On 29 June 2023, the European Commission published the new Machinery Regulation 2023/1230. This regulation replaces the Machinery Directive (2006/42/EC). The Machinery Regulation lays down the requirements and conformity assessment procedures that machinery has to fulfill before they are allowed to be sold or used in the European Union market.

You can download the text of the regulation here. More information about what you need to know about the new Machinery Regulation can be found here.

The Machinery Regulation has been in the making for more than five years. The Regulation introduces requirements for robots and artificial intelligence. Technologies that were not widely available at the time the Machinery Directive (2006/42/EC) was published.

In the next weeks, we will inform you about what the changes are that the new Machinery Regulation brings to the Machinery Directive (2006/42/EC).

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Do you have applied standards to prove compliance in regard to the mentioned regulations? We recommend you to check the new list of standards to see if any of the standards you applied have been updated. If so, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity. See the amendments here

Links and Downloads

• EC Amends the List of Standards under the PPE (Personal Protective Equipment Directive)
• OPSS Statutory Guidance Updates December 2022

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On December 29, 2022, the British Office for Product Safety and Standards (OPSS) published three product safety and product liability updates. We have listed them for your convenience. Do you have applied standards to prove compliance in regard to one or more of the mentioned regulations? We recommend you to check the links below to see if any of the standards you applied have been updated. When regulations have been updated by this list, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity.

• Designated standards: recreational craft
• Designated standards: equipment for explosive atmospheres
• Designated standards: pressure equipment

Links and Downloads

More OPSS updates from December 2022: OPSS Statutory Guidance Updates December 2022

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In December 2022, the British Office for Product Safety and Standards (OPSS) published a large number of updates related to product safety and product liability. We have listed them for your convenience. Do you have applied standards to prove compliance in regard to one or more of the mentioned regulations? We recommend you to check the links below to see if any of the standards you applied have been updated. When regulations have been updated by this list, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity.

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Do you have applied standards to prove compliance in regard to the mentioned regulations? We recommend you to check the new list of standards to see if any of the standards you applied have been updated. If so, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity. See the amendments here

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Do you have applied standards to prove compliance in regard to the mentioned regulations? We recommend you to check the new list of standards to see if any of the standards you applied have been updated. If so, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity. See the amendments here.

The post EC Amends the List of Standards under the Radio Equipment Directive 2014/53/EU appeared first on cemarking.net.

“How much does CE certification cost?”

It is a very understandable question. I am sure that it is on your mind as well. Before you start the process of getting the CE marking, it is good to have an overview of the costs involved. But most people do not realize how difficult it is to answer this question.

Actually, it is similar to going to a builder, say that you want a six-room house on two acres, and asking to know the costs. That question is simply impossible to answer. There are far too many variables. It is the same with CE marking and CE certification. There are so many variables that can affect the price you pay. You don’t buy CE marking by the pound.

The price of CE certification can differ greatly from one product to another. I have seen prices range from $ 64 to $ 64,000. The price is often affected by which certification procedure applies to the product, whether the company can do some or all of the conformity assessments themselves, as well as the level of support needed to prepare the required compliance documents, Technical File, user manuals, and product labeling.

Which CE certification procedure or procedures applies/apply, is based on the technical specifications of a product, as well as its ‘intended purpose’. Only when these factors are clear, the correct CE marking directive or directives (yes, a product can be covered by more than one CE directive at the same time), European harmonized standards, and certification procedure can be determined.
In many cases, the CE directives offer two or more certification procedures that may be used. The costs associated with one or the other procedure can vary, and thus this is one of the aspects to keep in mind.

What do you need to know to get an accurate overview of the costs of CE certification?

You need to clarify the following points:

• Which CE directive or CE directives apply/applies to the product?
• Which standards apply to the product? And do these standards have the status of European harmonized standards or not?
• Which certification procedure or procedures applies/apply?

With this information, you can compare quotes from service providers such as test laboratories, certification bodies, and consultants and ensure that will provide the same service. (Compare apples to apples!)

To determine the costs of CE certification you also should take into account the following aspects:

a. Are you required to involve a 3rd party certification body, or are you allowed to do self-certification?
The biggest myth about CE certification is:

“To get CE marking, products must be tested and certified by a third party certification body”.

This myth has cost a lot of companies a lot of money. In almost 90% of the cases, the CE marking regulations allow products to be self-certified for CE marking. In other words, you can do the CE marking yourself and you are not required to have the product certified by a third-party certification body. Obviously, CE marking self-certification can save your company a lot of time and money.
You too can learn to do CE self-certification. For example, with our online guides and courses, it is quite easy.

b. Is it possible for you to do in-house testing/inspections, or do you need to subcontract this?
Many of the required tests and conformity assessments can be performed by your company. Simply because it is a visual inspection or because it does not require special equipment and test equipment is available (or can be obtained).

c. Is it possible to leverage the tests and certifications already done by suppliers?
In many cases, it is possible to skip certain tests because they are already done by component or part suppliers. That can save you a lot of costs.

d. Do you want to combine CE marking with other (private) certifications/markings (e.g. GS, TUV, NEMKO, DEMKO, SEMKO, etc., etc.)?
There are testing and certification bodies that are accredited for various international markings and certification schemes. With one basic test in combination with some targeted additional tests, your product can be approved for many markets, and thus you can spread the costs of certification over a bigger number of products.

e. Can you buy CE-approved parts or components that will make your own CE marking effort easier?
I can give you a practical example: one of my clients manufactures a small optical inspection tool (a small car with a video camera) with an RF remote control module. The RF module was purchased from a vendor, and it already was CE approved. And as a result, my client did not have to test his product against the RF standards.

f. Have you thought about the internal company resources you require for CE marking? Do these have to be included in your budget?
What I mean here are the costs of the persons who will have to dedicate time to the initial CE (self) certification, and afterward to keep updated with the regulations and standards.

g. Have you taken into consideration that the existing design may not pass the conformity assessments and that it needs to be modified? How much time and money does it cost us to make design changes? How much does it cost us to do the re-testing?

As you can see there are many things to consider. All aspects mentioned above have an effect on the costs. In most cases, you can do a lot yourself, possibly with some guidance and instructions, thus saving a lot of money. Risk analysis, the compilation of the Technical File, conformity assessment against essential requirements of the directives and standards, and the Declaration of Conformity. These all can be done by you or your colleagues if you invest a little time in learning how to do it.

The biggest costs in CE certification are inherent to the time that test laboratories, certification bodies, and consultants need to spend on your products. I think that by looking at your product, you can already estimate that the time investment for conformity assessment, risk analysis, or the compilation alone is at least a full day of work, and likely more. Multiply this with a reasonable hourly fee, and you will conclude that the cost of CE certification easily exceeds $1500. For product testing alone you often need several days to run the required test procedure. I have seen wear and tear tests for construction products that take 1 month!

Surely, you may find laboratories and consultants in the market who claim they can do it for a very low fee. My experience and the experience of my clients with these companies is that the provided services are very cheap as well. Please consider this: the CE marking is about providing evidence that the product complies with the applicable requirements. In the case you have to involve a test laboratory or certification body, it is better to use a well-established, reputable company than a cheap unknown company. Because when your product’s CE compliance is challenged, its acceptance by authorities and your customers depend on the reliability of the (test)certificate and report.

At CEMARKING.NET, we have developed a Six Step CE Marking Framework that helps you to do as much as possible yourself, thus reducing the costs of CE marking. We offer this Framework as an On-Line Workshop, as a Coaching Program, and as a Done-For-You service. The first step is dedicated to determining which directives and standards apply to your products, and how you can do the CE marking efficiently and in a cost-effective way. For this, we conduct a documentation review and a gap analysis. We offer this first step of our framework as a separate service. That means you can get a report with an overview of the applicable requirements and recommendations with the steps you need to take, without investing in the full-service package. Contact us for more information on our services.

Want to reduce the costs of CE marking?

Learn more about our Six Step CE Marking Framework and how we help you to reduce the costs of CE certification. Click the Start Now button below. 

How much does CE certification cost? was updated on September 29-2022.

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IVDR Guidance Published Until Eudamed is Fully Functional – published on cemarking.net – July 18, 2022

Why this IVDR Guidance?

In the absence of a Eudamed database, the European Commission released guidelines on Wednesday for European Union member states and other parties on the implementation of certain In Vitro Diagnostic Medical Devices Regulation (IVDR) rules.

According to the EU, the guideline “intends to describe harmonized administrative practices and alternative technical solutions for information exchange until Eudamed becomes fully functioning.” The guidelines will enable member states and others to satisfy their commitments now that the IVDR’s phased implementation has begun while minimizing extra costs.

The guideline is intended for situations in which “the exchange of information would be difficult, if not impossible, to achieve based on the equivalent requirements of the in vitro diagnostic medical equipment directive,” according to the commission.

IVDR Guidance With an Amendment to the Timeframe

The European Commission has amended its timeframe for a fully operational Eudamed, with the goal of having the medical device database fully operational by the second quarter of 2024.

Eudamed is a database that will record every medical device permitted for use in the 27-member European Union, allowing national medical authorities and device manufacturers to be aware of authorized device usage, safety concerns, recalls, and new laws.

Links, Sources and Downloads

Other, related articles that may be of your interest:

• MDCG Publishes MDR Surveillance Guidelines

IVDR Guidance Published Until Eudamed is Fully Functional. The latest update is from July 18, 2022

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Ecodesign of energy-using products: the UK market versus the Northern Ireland market is also published on Product Compliance Manager on July 18, 2022

What is it about?

There are some differences in the rules for Great Britain (England, Scotland and Wales) on the one hand and Northern Ireland on the other. These have existed since 1 January 2021. The latest update is a publication dated 14 July 2022. Below is a summary of the differences. 

Overview

Many energy-related products have to comply with specific laws regarding their energy consumption. This is mainly to reduce the impact on the environment through increased efficiency and lower CO2 emissions.

All products that fall within the scope must:

• have supporting technical documentation (often called a technical file) to show that they comply with the regulations
• Have a declaration of conformity 
• have the appropriate conformity markings for the UK and/or NI markets, as applicable.

In Great Britain and Northern Ireland, the Ecodesign for Energy-Related Products Regulations 2010 (as amended) is the underlying legislation. However, there are differences in the way the Directive is applied in Great Britain and Northern Ireland.

What is covered by the regulations?

The Regulations cover the following energy-related products:

• air conditioners and comfort fans
• Air heating and cooling
• Circulation pumps
• computers
• dishwashers
• domestic ovens
• electric motors
• electronic monitors
• external power supplies
• fans
• lighting products
• refrigerated storage cabinets
• cooling appliances
• servers
• set-top boxes
• Solid fuel boilers
• space heaters
• stand-by and off mode
• transformers (guidelines for the reduction of regulations on power transformers)
• tumble driers
• hoovers
• ventilation
• Washing machines and washer-dryers
• boilers and water tanks
• water pumps
• welding equipment

(Products within the scope may also be subject to the Energy Information Regulations).

How to comply

A Declaration of Conformity must be completed, supported by technical documentation to demonstrate conformity. All documentation must be kept available for inspection for a period of at least 10 years from the date the product was last manufactured. It must also be made available to OPSS within 10 working days upon request. OPSS is explained further in this article.

Manufacturers

Manufacturers must also declare conformity with all relevant legislation by affixing

• the UKCA mark, in the case of a product placed on the market in GB; and/or
• the CE mark, in the case of a product placed on the market in NI

Some products will also be subject to regulations requiring mandatory third party conformity assessment.

Importers

Importers must:

• confirm that manufacturers have complied with the regulations for a product they place on the market in GB and/or NI
• retain a copy of the Declaration of Conformity
• ensure that the technical documentation is available to OPSS on request for 10 years from the date on which the last product was placed on the market

If an importer places a product on the GB or NI market under his own name or trademark, he must comply with all the manufacturer’s obligations.

Distributors

From 1 January 2021 some distributors will become importers and should know their obligations if their status has changed. You become an importer if:

• you are the first to bring goods from outside the UK and market them in the UK. Read more about how this change may affect you.
• you are the first person to bring goods into Northern Ireland from Great Britain or another non-EU country and place them on the Northern Ireland market. Read guidance on how this change may affect you.

If a company changes a product in a way that may affect the conformity of that product, it must comply with all the manufacturer’s obligations.

The role of the Office for Product Safety and Standards (OPSS)

The OPSS is the designated market surveillance authority for the Ecodesign Regulations in Great Britain and Northern Ireland.

Links and Downloads

Where to find more information for Great Britain?

• Ecodesign for Energy-Related Products Regulations 2010 (as applicable in GB)
• Ecodesign for Energy-Related Products and Energy Information (Amendment) (EU Exit) Regulations 2019 (as applicable in GB)
• Ecodesign for Energy-Related Products and Energy Information (Amendment) (EU Exit) Regulations 2020 (as applicable in GB)
• Energy Information Regulations 2011 (as applicable in GB)
• Ecodesign for Energy-Related Products and Energy Information (Lighting Products) Regulations 2021 (as applicable in GB)
• Ecodesign for Energy-Related Products and Energy Information Regulations 2021 (as applicable in GB)
• Ecodesign for Energy-Related Products and Energy Information (Amendment) Regulations 2021 (as applicable in GB)
• Placing manufactured goods on the market in Great Britain
• Read further information on conformity assessment and the appropriate markings.
• Read the latest information on UKCA and CE marking
• Read further information on placing goods on the GB market.

Where to find more information for Northern Ireland?

• Ecodesign for Energy-Related Products Regulations 2010 (as applicable in NI)
• Energy Information Regulations 2011 (as applicable in NI)
• EU Directive 2009/125/EC establishes a Framework for the setting of ecodesign requirements for energy-related products (as applicable in NI)
• Placing manufactured goods on the market in Northern Ireland

Other, related articles that may be of your interest:

• UK General Product Safety Regulations 2005
• Product Safety and Noncompliance Notification Guidance for Business
• PAS 7100:2022 on Supporting better product recalls.
• Product Safety and Noncompliance Notification Form
• EU Product Safety Business Alert Gateway system
• Product Safety Alerts, Reports, and Recalls site
• OECD Global Recall Portal
• EU Toys Safety Directive explained
• Making sure of complete European compliance, including the UK

Ecodesign of energy-using products: the UK market versus the Northern Ireland market, the latest update is from July 18, 2022

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What is the Objection of the German Government?

On June 16, 2022, the Federal Republic of Germany filed an objection under Article 11 of Regulation (EU) 1025/2012 of October 25, 2012 on European Standardization. The objection specifically addresses two standards included in this regulation. These are:

• EN 62841-1:2015 – Electrically powered hand-held tools, portable tools and lawn and garden equipment – Safety – Part 1: General requirements
• EN 62841-2-11:2016/A1:2020 – Electrically powered hand-held tools, transportable tools and lawn and garden equipment – Safety – Part 2-11: Particular requirements for hand-held reciprocating saws.

The Federal Government finds that the essential health and safety requirements of “Directive 2006/42/EC on machinery and amending Directive 95/16/EC (recast)” have not been fully taken into account.

Insufficient Protection

Germany is of the opinion that the two standards for electric jigsaws do not provide sufficient protection against unintentional starting after loss of voltage. Therefore, the suspicion arises that these standards are not in full compliance with the relevant parts of the Machinery Directive 2006/42/EC. The German government asks the Commission to take appropriate measures against the aforementioned standards immediately.

In its objection, the Federal German Government formulates the shortcomings of both standards in detail.

Conclusion:

According to the Machinery Directive 2006/42/EC, hand-held electrical machines, such as jigsaws, must incorporate technical solutions that exclude re-starting. This is regardless of the cause of the loss of voltage. From a German perspective, there is no reason why the regulations of the machinery directive should not be implemented.

From the German government’s point of view, the publication of the title of EN 62841- 1:2016-07 and EN 62841-2-11:2016/A1:2020 in the Official Journal of the European Union should be accompanied by a warning notice for the above reasons.

At the same time, a mandate should be given to CEN to revise the relevant standard with respect to the weaknesses objected to.

German Objection Machinery Directive 2006/42/EC – Links and Downloads

• Official download of the formal objection
• REGULATION (EU) No 1025/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2012
• Machinery Directive – 2006/42/EC

Other articles that may be of your interest:

• Harmonized Standards Toy Safety Directive: Important Validation Announcement
• Functions and Effects of European Standards: The Final Study

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Instructions for the use of medical devices are increasingly provided in electronic form. They replace the paper version. In order to regulate this properly, the Implementing Regulation (EU) 2021/2226 is in force as of January 2022.

Why this Implementing Regulation?

Since 2012, manufacturers have had the opportunity to offer instructions for use in electronic form. The framework that these previously had to comply with, is described in the EU Regulation 207/2012. This covers the old MDD and the AIMD. However, the requirements on electronic operating manuals are being adapted to the new regulatory framework of the MDR. It will be fully effective as of May 26, 2022.

Therefore, the EU Commission has decided to repeal the previously applicable regulation entirely: (EU) 207/2012 is no longer valid from the aforementioned date (with a few exceptions).

Transfer to the New Standard: (EU)2021/2226

A large part of the provisions from the old standard are also in the new one. These have been transferred without changing anything. The new regulations partly contain exactly the same phrasing and carry only a few new features. The goal is still to prevent environmental pollution by providing electronic instructions for use. It regards certain medical devices and the aim is also to reduce costs for the medical device industry. The existing level of safety should at least be maintained.

Furthermore, there are also medical devices that fall under the transitional provision of article 120, paragraph 3 of the MDR. These may be placed on the market or put into service until 26 May 2024. They will continue to comply with the requirements under the old Regulation No. 207/2012 for two more years.

Necessity and Content of the Instructions for Use According to the MDR

The instructions for use of a medical device include all information provided by the manufacturer. That includes information for the user on the purpose and proper use of the respective device. In addition, the manual also explains any precautionary measures. The information is provided together with the medical device and is mandatory for medical devices of all risk classes. Nevertheless, the MDR also provides for an exception (which is described in Annex I, Chapter III, point 23.1 under section d).

There is a possibility for devices under classes I and IIa to dispense with instructions for use. This is only possible if safe use of the devices concerned can be ensured even without instructions for use. The content of the instructions for use is determined by section 23.4, Chapter III, of Annex I to the MDR. However, the more extensive conditions for providing instructions for use in electronic form are specified in the new Implementing Regulation 2021/2226.

Scope of Application Limited to Certain Product Groups and User Circles

The scope of the new implementing regulation includes medical devices according to the MDR. There are also exceptions to this, which are listed in Annex XVI of the MDR. These are products without a medical purpose. However, not all manufacturers are allowed to switch to an electronic manual without further ado (according to the limitative enumeration in Art. 3(3)). That possibility is only offered to manufacturers of the following product groups:

• implantable and active implantable medical devices and accessories
• fixed installed medical devices and accessories
• medical devices and their accessories fitted with a built-in system that visually displays the instructions for use

Additional Limitation Regarding this Product Group

A further restriction applies: the aforementioned devices must be intended exclusively for use by professional users. Use by other persons is not reasonably foreseeable. “Professional users are “persons who use the medical device in the exercise of their profession as part of healthcare activity”.  The main novelty compared to the old Regulation 207/2012 is that the limitation to professional users does not (any longer) extend to medical software. Manufacturers are now also allowed to provide instructions for use in electronic rather than paper form for software that can be used by laypersons.

What is Not Included in the Scope of the New Implementing Regulation?

There are IVDs (in-vitro diagnostic devices) that fall under Regulation (EU) 2017/746. This is the standard for in vitro diagnostic medical devices (IVDR). These products do not fall within the scope of Implementing Regulation 2021/2226.

The IVDR defines a possible derogation in Annex I, Chapter III, Section 20 under section f. Manufacturers may omit the paper manual and replace it with an electronic instruction manual under one condition. That is when the IVD is intended for professional use only and is not intended for testing in the presence of patients.

Documented Risk Assessment

A manufacturer is still required to conduct a risk assessment. This must be documented and updated based on the experience gained in the period after the product has been placed on the market. For this reason, an article has been included that lists a set of minimum requirements for the risk assessment, Article 4.

Furthermore, it should include an explanation of user needs. Also, the risk assessment must include a description of what hardware and software are needed to display the electronic operating instructions.

In addition, the legal manufacturer is required to address, among other things, foreseeable medical emergencies in which information in paper form may be needed. 

Finally, the assessment calls for a protocol that users can follow if there is a (temporary) malfunction of the relevant website.

Addition to the New Risk Assessment Compared to the Old Standard

Article 4 of the new regulation added two items to the manufacturer’s assessment criteria:

• evaluation of the compatibility of the website when displayed on different devices that can be used to display the electronic instructions for use; and
• management of the different versions of the instructions for use.

Further Requirements for the Provision of Electronic Instructions for Use

The implementation of the risk assessment is not the only thing that manufacturers must comply with. There is also an extensive list of additional requirements. These are described in Articles 5 to 7. However, not much has changed compared to the previous standard. The requirements that were listed still apply today. They include the following aspects:

• The manufacturer must have a system for providing the paper instructions for use to the user free of charge and no later than seven calendar days after a request by the user.
• There is a clearly defined framework indicating how long manufacturers must keep the electronic instructions for use available to users. This is not uniform for all devices. It differs for each specific product or product group.
• The label must clearly indicate that the product’s instructions for use are provided in electronic rather than paper form. If it requires software to use the manual, this information must be provided in a place where access to the software is provided.
• The manufacturer must also make the electronic manual available on a website when:
  • the manufacturer does not make the electronic instructions available on an electronic storage medium that accompanies the product; and
  • if the electronic instructions for use are displayed by means of a system built into the product.

The website must comply with requirements listed in Article 7 (2) of the Implementing Regulation. If a manufacturer decides to offer both an electronic and a paper version of the user manual, the two must be identical in content.

One New Requirement In addition to the Existing Standard

This is described in Article 5(15). The manufacturer is required to put in place effective systems and procedures. Those procedures must ensure that users can be informed about adverse reactions or corrective actions after they have downloaded the electronic instructions for use from the website. This new information obligation will not only require a manufacturer to implement appropriate technical measures. Manufacturers will also have to look at this critically from the point of view of data protection legislation.

Electronic operating instructions must also be made available on the manufacturer’s website. In doing so, conditions are imposed on the language and on the availability of historical versions.

Conclusion

The new regulation is not very innovative compared to the previous standards. This is especially the case when you consider the speed of new digital developments. Medical device manufacturers are not really given the option to abandon paper user manuals altogether. These must be available at all times.

However, a pleasant change has also been made. That is the provision of the user manual in electronic form for medical software for layman’s use. This offers an advantage to manufacturers when they offer apps that must qualify as medical devices because of their intended medical purpose. Nonetheless, these apps raise the question of the extent to which they are actually medically ‘qualified’ and whether they confuse the user. But that is another (important) discussion.

Either way, an intensive analysis of the provisions of the new implementing regulation is advisable. This is not only for medical device manufacturers who have already used the option of electronic instructions for use under the previous regulatory framework.

(EU)2021/2226 explained: Electronic Manuals for Medical Devices – Sources, Links, and Downloads

• Official publication of the Commission Implementing Regulation (EU) 2021/2226
• Medical Devices Directive – 93/42/EEC
• Harmonized Standards Toy Safety Directive: Important Validation Announcement
• Functions and Effects of European Standards: The Final Study
• MDCG Publishes IVDR Guidelines MDCG 2022-6
• MDCG publishes MDR Surveillance Guidelines
• List of Harmonized Standards for Quality Management Systems, Sterilisation and the Application of Risk Management to Medical Devices Has Been Updated
• Electronic instructions for use of medical devices – Requirements under new Implementing Regulation (EU) 2021/2226, post on Lexology by Taylor Wessing

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Important Validation Announcement

This notice specifically regards the harmonized standards of the flammability requirements for toys. It also concerns changes in the standard for the toxic metal migration test.

The old standards EN71-2:2011 + A1:2014 (part 2), and EN71-3:2019 (part 3) are no longer valid. In effect, this updated list is important to all manufacturers of CE-marked products that have used European harmonized standards to prove CE compliance according to these regulations. So, did you test your toys according to one or both of these standards? You need to update your files. Possibly, you also need to have the toys retested.

Our post on Product Compliance Manager (in the ‘news and announcements’-section) outlines the changes for your convenience. Possibly, this publication is only available to subscribers. Feel free to subscribe, it is at no cost. We don’t like spam either, so we will not send it after you have subscribed.

Other, related articles, that may be of your interest

• List of Harmonized Standards for Quality Management Systems, Sterilisation and the Application of Risk Management to Medical Devices Has Been Updated
• Updated List of Harmonized Standards QMS and the Application of RM to MD
• Amendments List of Standards Machinery Directive 2006/42/EC
• Amendments List of Standards EMC Directive (2014/30/EU)

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Subtitle: Study on the Functions and Effects of European Standards and Standardization in the EU and EFTA Member States.

Introduction

In 2021, the European Commission published its roadmap for a new standardization strategy. The aim of the new strategy is to address the challenges facing the European standardization system. During an 18-month period, different categories of stakeholders from EU and EFTA Member States were consulted as part of this roadmap. The main results are now published in this study.

The objective of The Study

First of all, it is good to report the following about the European Standards (EN) definition in this report. It is fully in line with the definition as it is in Regulation 1025/2012. This does not take into account:

• the European Standards are the adoption of international standards (identical or modified),
• the European standards are integrally developed at the European level.

The EC strives for better regulation and improved competitiveness of European industry. This study will support this endeavor. It highlights not only the strengths of European standards and standardization, but also the weaknesses. The key question here is what economic and societal effects the current standardization is having. 10 sectors have been selected on which this question is projected. The main methods of data collection are desk research and field research.

The outcome of The Study on the Functions and Effects of European Standards

The researchers conclude that a lot of value is generated by the European standardization system. Also in view of the two major transitions that the economy is currently going through: the digital and the green. The added value of European standards is recognized by almost all companies. It has a positive effect on several dimensions at sectoral level. It also shows that European standardization is a powerful tool to promote a more efficient and effective cooperation between different market participants within the value chain. Furthermore, it also benefits the exchange of technology between various market players.In addition, positive effects are highlighted in the following areas:

• it is a source of efficiency (such as resources, inventories, circularity of products),
• one can use it as a tool to reduce risks (for organizations, their employees, the environment or for consumers),
• compatibility between products, sectors or applications is better ensured

At the same time, the study also points out possible improvements to the European standardization system. Thus, 30 different recommendations are made for further modernization of the European standardization process.

Functions and Effects of European Standards: the Final Study – Links and Downloads

• Official EC page of the final report

Other articles that may be of your interest:

• MDCG Publishes IVDR Guidelines MDCG 2022-6
• MDCG publishes MDR Surveillance Guidelines MDCG 2022-5
• EU Roadmap to Reduce Chemicals
• List of Harmonized Standards for Quality Management Systems, Sterilisation and the Application of Risk Management to Medical Devices Has Been Updated

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After a nine-month delay, the EU’s new In Vitro Diagnostic Medical Device Regulation has finally selected a seventh Notified Body (IVDR).

3EC International From Bratislava Joins Names as BSI, Dekra and TüvSüd

At long last, another Notified Body has been established under the IVDR. 3EC International a.s., a Slovakian certification organization located in Bratislava, has been approved to undertake conformity assessments for in vitro diagnostic medical devices (IVDs) under the IVDR, joining larger competitors such as BSI, Dekra, and TÜV SÜD. 3EC is already a certified Notified Body under the new Medical Device Regulation (MDR) and the old Medical Device Directive and the In Vitro Diagnostic Medical Directive.

Notified Body Capacity is Still Far Behind

With only three weeks until the IVDR’s Date of Application on May 26, 2022, all IVDs must be compliance assessed under the IVDR.  Unless they qualify for the IVDR’s restricted transitional provisions, any increase in Notified Body capacity is welcome news. The designation of 3EC, on the other hand, has little impact on the overall issue: Notified Body capacity for IVDs is still far behind what is required to handle the increased conformity assessment burden brought on by the IVDR. The continuous shortage of Notified Body capacity is a major roadblock to bringing new IVDs to market, as well as maintaining existing ones on the market.

This recent classification also doesn’t imply that the rate of increase in Notified Body capacity is speeding up. The latest Notified Body designation under IVDR occurred in August 2021, nine months ago, and the next designation is not projected until October 2022, still five months away.

Smooth Transition to IVDR Seems to be Wishful Thinking

Straightforwardly, the ship has sailed in terms of having enough Notified Body capacity to ensure a seamless rollout of the IVDR. For a long time, the industry will have to make do with the tiny number of Notified Bodies that are available and whatever support the regulators can provide. We all hope that the transition to the IVDR would be smooth, but this is more wishful thinking than expectation at this point.

New IVDR Notified Body in Slovakia: Sources, Links and Downloads

• Alex Denoon and Jamie Hatzel from Bristows LLP in Lexology
• Info about 3EC in the Official Journal of the EC

Other, related articles, that may be of your interest:

• MDCG Publishes IVDR Guidelines MDCG 2022-6
• MDCG publishes MDR Surveillance Guidelines MDCG 2022-5
• New MDCG guidelines for MDR compliance of older devices and requirements for parallel imports into the EU

The post New IVDR Notified Body in Slovakia appeared first on cemarking.net.

To Whom it Applies

The aim of this guidance document is to provide clarification on the concept of “significant changes in the design and intended purpose” under IVDR Article 110(3). It applies to producers of devices that comply with Directive 98/79/EC. Furthermore, they are placed on the market or put into operation after May 26, 2022, during the transition period. It must also be in accordance with Article 110(3) IVDR, regardless of whether those devices required notified body involvement under the IVDD at the time.

To Whom it Does Not Apply

The process for manufacturers submitting and notified bodies assessing changes to the approved design or substantial changes to the approved quality system or the line of products covered that are part of the conformity assessment process and surveillance defined by the appropriate notified body under the IVDD is not covered in this guidance document.

What is Included?

• The determination of whether alterations are “substantial changes in the design or intended purpose” in accordance with IVDR Article110(3).
• Changes not concerning the design or the intended purpose
• Changes that do concern the design or the intended purpose

FLOWCHARTS:

• CHART A – Changes in the intended purpose
• CHART B – Changes in the design
• CHART C – Changes in the software
• CHART D – Changes related to an ingredient or material
• CHART E – Changes in the design

The Assessment of Changes

Devices should not undergo any major changes in design or intended purpose after the date of application of the IVDR (that is 26 May 2022), in order to benefit from the transition periods established in Article 110(3) IVDR. This condition consists of two elements:

• there is a change in the design or intended purpose and
• that change is non-significant.

Article 110(3) IVDR does not apply to adjustments that do not affect the design or intended function of the product. Changes to the design or intended purpose, on the other hand, are only covered under Article 110(3) IVDR if they are considered “substantial.” The manufacturer is always responsible for demonstrating that adjustments do not have an impact on the design or the intended purpose. When a modification is likely to influence the device’s design or intended purpose. Furthermore, the relevance of the change should be evaluated on a case-by-case basis. Also, this must be accompanied by evidence to support the assessment’s conclusion. When the changes are considered insignificant, the maker must be able to justify their decision. Importantly, when a competent authority requests it, the justification must be documented and made available.

Moreover, there are additional considerations for devices covered by a certificate issued by a notified body. These are further explained in the document as you can find in the link below this article.

Changes Not Concerning the Design or Intended Purpose

Even if they have to be incorporated in the information to be supplied with the device, changes in the manufacturer’s organization (administrative changes) or changes in the manufacturing process should not be considered changes in the design or intended purpose within the scope of Article 110(3) IVDR (e.g. label or instructions for use). This includes for example:

• changes of the manufacturer’s name, address, or legal form, including a merger or acquisition involving the manufacturer;
• changes in relation to the authorized representative;
• relocation or addition of new manufacturing sites, including when it affects subcontractors or suppliers;
• changing the supplier of a material, ingredient, or component, provided the specifications of the new material, ingredient or component do not change;
• adding or replacing a new material number for logistic reasons without changing the material;
• changes to outer packaging (e.g. size, material, layout) that do not adversely affect the stability, sterility or microbiological state of the device;
• new process validation as part of manufacturing improvements or scale-up of manufacturing.

Changes in the QMS have little effect on the design or intended purpose, as long as the conditions for which the conformity assessment certification was issued are met.

Changes That do Concern the Design or the Intended Purpose

This paragraph in the guidelines addresses several subjects. First of all, it addresses the design and the intended purpose. Secondly, it explains the significance of changes. Thirdly, it clarifies some general considerations. These are further described in the document as you can find in the link below this article.

Flowcharts 

MDCG 2022-6 Annex and Chart A:

MDCG 2022-6 Chart B and Chart C:

MDCG 2022-6 Chart D and Chart E:

To analyze the flowcharts we kindly refer to the guidance document MDCG 2022-6 as listed below this article.

MDCG publishes IVDR Surveillance Guidelines – MDCG 2022-6: Sources, Links and Downloads

• EC official page for the MDCG
• MDCG 2022-6 download

Other, related articles that may be of your interest:

• MDCG Publishes MDR Surveillance Guidelines
• Extension of Delegated Powers MDR & IVDR? EC Wants 5 More Years

The post MDCG Publishes IVDR Guidelines MDCG 2022-6 appeared first on cemarking.net.

It continues to ail with Philips Respironics’ devices. After yesterday’s publication on the recall of the V60 family of ventilators, we now continue with the problems surrounding Philips Respironics’ sleep apnea and respiratory devices. Elise Reuter of MedTech Dive recently published an article on the latest problems at the manufacturer. In this article she talks, among other things, about the subpoena issued to Philips Respironics by the U.S. Department of Justice.

Subpoena for Philips Respironics

On April 8, 2022, the company received a subpoena from the U.S. Department of Justice. In it, it is summoned to provide information about the recall of their sleep apnea and respirators. Last week, the Royal Philips CEO, Mr. Frans van Houten, indicated that the company will spend even more money to solve the quality problems at Respironics. In a response to the subpoena, he said:

“At the moment it is a subpoena for information. This means that the prosecution is preparing an investigation. We just have to accept that.”

Frans van Houten (Royal Philips CEO)

“Requiring Philips to Present a Recall Plan “

The Center for Devices and Radiological Health (CDRH) is proposing to require Philips to submit a plan for recalling sleep apnea and respirators. The CDRH is the division of the United States Food and Drug Administration (FDA) responsible for approving all medical devices before they are marketed. It also oversees the production, performance and safety of these devices. 

What is Going on With These Devices?

Back in 2021, Philips announced that there were problems with the soundproofing foam of the Dreamstation series of sleep apnea and breathing devices. As a result, there is a risk of users inhaling or swallowing particles. This in turn leads to those users potentially being exposed to harmful substances. An FDA spokesperson stated at the time, “Once broken down, the foam can cause serious injury, including injury that may be life-threatening, cause permanent injury, and/or require medical intervention to prevent permanent injury. “

From that point on, Philips Respironics’ quality problems accelerated. As a result, the scope and cost of the original repair and replacement program increased significantly. However, in some cases patients may continue using the affected devices if stopping would pose a greater risk than continuing to use it. You can read this in the FDA’s Safety Communications about the recall. The latest update in this publication is from May 2, 2022.

What does the near future look like?

It is likely that the effects of the quality problem will last for a long time. Even after Philips has repaired or replaced the affected devices. Additionally, in March 2022, there were no less than 185 personal injury lawsuits pending against Philips. Furtermore, there were also 100 class actions related to these problems. Philips expects the class actions to be consolidated into two cases in the summer. In conclusion we can say that the end of the misery at Philips Respironics does not seem to be in sight for the time being.

More Problems Philips Respironics: Sleep Apnea Devices also Remain a Concern: Sources, Links and Downloads

• Elise Reuter of MedTech Dive 
• Jim Hammerand of MedicalDesign

Other related articles that may be of your interest:

• Philips Respironics Voluntarily Recall of V60 Ventilator Product Family
• Philips Health Systems Ventilators Safety Hazard Alert

In addition, some more blogs about this subject:

• Philips Respironics Receives FDA Notification Order
• ‘Philips is liable for health problems’ say users of apnea devices

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On April 22, 2022, Philips Respironics publicly announced the recall of a trio of medical devices. This is not the first time these devices have been in the news due to life-threatening flaws in the technology used. We have also published about this before (at the bottom of the “Links and Downloads” section are the links to our earlier publications).

The US FDA (Food and Drug Administration) also made the announcement of Philips Respironics. That was on May 2, 2022. By the way, they always do this when a manufacturer has a voluntary recall. It purely serves to inform the public and is not an announcement of a sanction against the manufacturer in question. If this proves necessary, a different procedure applies.

The Recall

“Royal Philips, a global leader in health technology, today announced that its subsidiary Philips Respironics is informing customers of its V60/V60 Plus and V680 fans of a possible problem with the electrical circuit in these fans that controls the 35V power supply to the fan and the alarm. Philips Respironics has already notified the relevant competent authorities. “

What’s Going On?

There can be a possible problem in the 35V electrical circuit with this equipment. As a result, there is a possibility that affected ventilation units will stop working. This can happen without triggering an audible and/or visual alarm (this is called a “Silent Shutdown”). As a result, a patient no longer receives respiratory assistance. Obviously, this is life-threatening. The manufacturer expects an average of less than one silent shutdown in a million users per year.

The Manufacturer’s Advice

On the advice of Philips Respironics, customers can do the following to reduce the danger:

First, Philips recommends implementing an oxygen analyzer with appropriate alarm settings for each V60/V60 Plus, or V680. Further, it is recommended that the equipment be connected to a nurse call system/remote alarm system. This is documented in the user manual. Upon request, Philips can provide technical assistance with this. Finally, there is the advice to monitor the patient. This can be done with pulse oximetry or other physiological monitoring appropriate to the capabilities of the facility and the needs of the patient.

In addition

When you use the V60/V60 Plus or V680 ventilator, an alternative ventilation method should be available. Then, when you detect a failure, you must immediately disconnect the patient and hook it up to the alternative device. Also, you must remove the ventilator from clinical use immediately and qualified maintenance personnel should repair the device

If these mitigations are not available, Philips Respironics “recommends that each institution make an informed decision weighing the risks and benefits of continued use of the V60/V60 Plus and V680 against the risks and benefits of discontinuing use and/or replacing other ventilators. Such decision-making must take into account the capabilities of the facility and the needs of the patient.”

How Will Philips Respironics Address This in the Future?

“We are committed to providing products and solutions that are safe and reliable for those who depend on them “ said David Ferguson, Business Leader of Philips Respironics. He continues by telling:“the V60 ventilator has been in use for over 10 years with a high state of reliability. We take every customer complaint seriously, and when we identify a problem, we address it thoroughly and transparently in consultation with the relevant competent authorities. We have assembled a dedicated team that is focused on addressing the current problem and providing technical support where needed. “The manufacturer will keep customers regularly informed of the development of its plan to address the problem. For that reason, the first update will be provided by June 30, 2022.

Information about the Device

First, it is important to note that the V60/V60plus is not a so-called “life-support ventilator”. It intends to improve the patient’s breathing. Therefore, this device is an “assistive ventilator”. In addition, we can say that the V80 provides both invasive and non-invasive respiratory support. All three types do not approve of use in a home or non-institutional setting.

The Nature and Scope of the Voluntary Recall

This is a voluntary recall notification for the US only. For the rest of the world, this is a field safety notice. It goes without saying that users in other parts of the world (than the USA) should be very vigilant when using these medical devices. In the USA, the FDA has classified the recall notification as a Class 1 recall.

Please report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Complete and submit the form online. By mail or fax: Download the form or call 1- 800-332-1088 to request a reporting form, fill it out and return it to the address on the pre-addressed form, or send it by fax to 1-800-FDA-0178

This recall conducts with the knowledge of the U.S. Food and Drug Administration.

Philips Respironics Voluntarily Recall of the V60 Ventilator Product Family: Links and Downloads

• FDA Announcement
• Philips Respironics voluntary recall and field safety notice

Other, relevant articles that may be of your interest:

• Philips Health Systems Ventilators Safety Hazard Alert (Cemarking.net Blog)
• Philips Respironics Receives FDA Notification Order (Cemarking.net Blog)
• ‘Philips is liable for health problems’ say users of apnea devices (Cemarking.net Blog)

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One of the tasks of each notified body is to continuously monitor the functionality of certified medical devices. The Medical Device Coordination Group (MDCG) has published policy rules for this purpose. It concerns devices with certificates issued under two old directives: the AIMDD and/or the MDD.

Article 120 – Transitional Arrangements Under the MDR

On March 26, 2021, the new regulations for medical devices in the EU entered into force. The transition of products from the old directives is regulated in Article 120 of the MDR. This states, among other things, that devices with a valid certificate under the old directives may be placed on the market until May 26, 2024. Unless their design or intended purpose is substantially changed.

Policy Framework Drawn Up by the MDCG

The communiqué focuses on the appropriate surveillance requirements by notified bodies under Article 120(3) of the MDR. Only devices for which a valid certificate has been issued under the AIMDD or the MDD earlier than 26 May 2021 are covered.

What Must the Notified Body Do?

First of all, the notified body establishes after examination which certificates under the old directives will continue to be used. This includes an inspection of the (future) area of application. Furthermore, rights and obligations under the old directives must be maintained. This is laid down in a contract. It is essential that this covers the monitoring activities until the end of the transition period (May 26, 2024).

The Manufacturer’s Transition Plan for Compliance with the MDR

The manufacturer has created a transition plan for compliance with the MDR. A notified body also assesses the scope of devices covered by the old directives. In doing so, it will need to take into account the manufacturer’s transition plan. This includes whether the manufacturer has adapted its quality management system in accordance with the requirements of Article 120(3) (Section 4.3 of the Directives).

The Audit Program

The notified body has the right to adapt the audit program. This is possible as a result of the evaluation of all documentation and this shows that it is necessary. Indeed, unannounced audits are also a possibility if there is reason to do so. Previously, not all MDR provisions applied to older devices. For that reason, the audit activities of the notified bodies should be a continuation of the previous monitoring activities. However, this is also with attention to the additional MDR provisions.

In Case of Lack of Conformity

An audit may identify a serious lack of compliance with the regulations. If this poses an unacceptable risk to the health and safety of patients or other persons, intervention is required. In this case, a notified body must inform the relevant competent authority. In the event that a certificate is suspended, withdrawn, restricted or canceled, the manufacturer’s notification requirements must be met, under Article 122 of the MDR.

Tool MDCG for Notified Bodies Performing Individual Audits

The requirements drawn up in the MDR’s guidelines have been defined by the MDCG in this table: 

This table is a tool for notified bodies performing individual audits. In addition to this table, the other, relevant, guidelines should also be used. In the case of Class IIa and IIb devices, Notified Bodies are requested to continue to apply the sampling plan established under the Medical Devices Directive to assess the technical documentation on a representative basis.

The guidelines also describe the possible scenarios that may arise if the technical records are assessed on a sampling basis. 

MDCG Publishes MDR Surveillance Guidelines; Sources, Links and Downloads

Sources:

• MDCG 2022-4
• MDCG 2022-5
• Charleen O’Keeffe, Aisling Casey and Sinéad Cullen from William Fry.com on Lexology

Other, related articles:

• Extension of Delegated Powers MDR & IVDR?
• EU Notified Body Medtech Services and How to Overcome the Urgent Shortage: a View from 3 Experts
• EU MDR 2017/745 What Changed?

The post MDCG publishes MDR Surveillance Guidelines appeared first on cemarking.net.

This roadmap is from the ECHA (European Chemicals Agency). In it, it defines its priorities in the period extending to the revision of the REACH regulation. This is estimated to be in 2027. Companies affected by this should prepare for the coming restrictions.

EU Strategy for Chemical Substances

In the EU, thousands of chemical substances will be curbed in the reasonably near future. This is described in a “Roadmap on Restrictions” from the European Commission. It published this on April 25, 2022 as part of the EU Strategy for Chemicals. Not only is this going to have essential consequences for the Chemical Industry. But also the manufacturers of products are going to be affected. They will probably have to adapt their articles. After all, they may not contain any substances in excess of the specified limits.

Objectives of the Restrictions Roadmap

The Restriction Roadmap has three main objectives:

1. This EU roadmap to reduce chemicals must ensure that the commitments under the strategy can be fulfilled in a transparent and timely manner. The Rolling List included in the Annex sets out the restrictions that have been planned and prepared, and those that have progressed, in particular for the most harmful substances. It will be the cornerstone for the multiannual planning under Article 68 of REACH on introducing new and amending current restrictions and Article 69 of REACH on preparing proposals for the period up to 2025-2027, until the new rules on the generic approach are put in place.
2. Provide an overview, through its Rolling List, of we are using the available authority resources. The Rolling List contains (groups of) substances that are being considered for a risk management measure or for which an entry in the Registry of Intentions (RoI) has been submitted.
3. This EU roadmap to reduce chemicals must provide transparency to stakeholders on the restriction work by authorities and allows companies to anticipate (potential) upcoming restrictions, e.g. by already beginning substitution activities

EU Roadmap to Reduce Chemicals – Roadmap Restrictions

The most remarkable thing about the EU roadmap to reduce chemicals is that the scope of this plan is very broad. Where the focus is now on individual regulation or regulation in small groups, that focus will undoubtedly shift. From now on, the focus will be on regulating chemicals by groups. All in all, the restriction process will have to be in place within 24 months. Furthermore, it is expected that around 2030 another 5 to 7 thousand chemicals will be restricted.

The UK government has yet to announce its chemicals strategy.

EU roadmap to reduce chemicals: Links and Downloads

• COMMISSION STAFF WORKING DOCUMENT Restrictions Roadmap under the Chemicals Strategy for Sustainability
• Emma Bichet and Jack Eastwood from Cooley

Other, related articles that may be of your interest:

• Consultation On RoHS Reform (EU)
• UK RoHS Update, April 2022 (UK)
• UK Guidance for Businesses on How to Notify Hazardous Products (UK)

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The European Commission wants to extend its delegated powers for five years. This is to be able to amend the MDR and IVDR where the text of the regulations allows. MDR stands for Medical Devices Regulation (EU) 2017/745. IVDR stands for In Vitro Diagnostic Medical Device Regulation (EU)2017/746.Indeed, in the past five years, the EC has not yet used its delegated powers. Earlier this week, Amanda Maxwell of Medtech Insight published an article. In it she talks about the report that the EC issued regarding the extension of its powers.

Delegated Acts or Implementing Acts?

It is good to explain the difference between the two. First, there are the delegated powers/acts. These give authority to amend or supplement basic laws. Then there are the implementing acts. These are aimed at implementing the basic laws. The uniform conditions for implementing those laws are ensured by the implementing acts.

MDR or IVDR?

It is also good to briefly explain the differences between the two regulations:

MDR

The EU MDR is the new EU legal requirement that applies to all medical devices manufactured in or supplied in the European Union. The MDR focuses on improving the identification of medical devices. It also aims to standardize technological advances in the field of medical devices.

IVDR

IVDR is specifically applicable to in vitro diagnostic medical devices manufactured and sold in the European Union. These are devices used to diagnose medical problems.

Milestone

We are back to the heart of the topic of this article: the European Commission wants to extend its delegated powers on the MDR and IVDR for five years. We are now almost five years after the adoption of the two regulations. This is an important milestone, not in the least because the EC was given this timeframe to adopt delegated acts. At that time, the medical device and IVD regulations were adopted. Also, in one month, on May 26, 2022, the IVD Regulation will apply in the EU.

Extension of Delegated Powers MDR & IVDR: The EC Wants 5 More Years

As mentioned above, the five-year deadline expires at the end of May 2022. But according to the Commission, more time is needed to adopt delegated acts. It has therefore issued a report to the European Parliament and the Council. This shows that the Commission has not yet adopted any delegated acts at all. The only “result” so far is that it is currently working on a delegated act for the UDI allocation for contact lenses. This is the conclusion after almost 5 years.

What Is the Usual Procedure?

Both the MDR and the IVDR mention that so-called “delegations of authority” are tacitly renewed. We are then talking about terms of the same duration. However, this does not have to be the case. Because in addition to this tacit extension, the European Parliament or the Council does have the right to object. The objection must then be made known at least 3 months before the end of each period.

Also, it says in the procedure that the EC must report no later than 9 months before the end of the five-year period. This is the report on the adoption of delegated acts under the regulations. It is issued to the European Parliament and the Council of the EU. This has not been done. Instead, the report was issued just before the end of the five-year period.

“It’s About the Bottom Line”

So the report shows that the EC has not yet used delegated powers under the MDR and IVDR. It acknowledges that there is currently “only limited experience of their application in practice”. In the report, the EC further stresses that “the rationale for delegating the power to adopt delegated acts has not changed. It is important to maintain the necessary flexibility in the legal framework,” it said, “to supplement or adapt it to technical and scientific … also on the basis of more experience with the application of the regulations”.

Executive Orders

The Commission, however, did use its powers to adopt implementing acts. It has adopted a total of 6. For example, one was recently adopted in the area of electronic operating manuals.

Updating Delegated Acts

Nevertheless, there have been advances over the past 5 years. The report discusses these in detail. A reference to the EC’s report to the European Parliament and the Council can be found below this article. 

Extension of Delegated Powers MDR & IVDR? Links and Downloads

• Amanda Maxwell from MedTech Insight
• REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL

Other, related, articles that may be of your interest:

• EU Notified Body Medtech Services and How to Overcome the Urgent Shortage: a View from 3 Experts
• EU MDR 2017/745 What Changed?
• French & German warning: EU must extend MDR transition period
• MDCG Addition to IVDR to-do List

The post Extension of Delegated Powers MDR & IVDR? appeared first on cemarking.net.

Finally, the new Polish national legislation on medical devices is a reality. The new regulations were signed by the President on April 20, 2022.

This has led to better consistency between the national law and the European directives. It now aligns with EU Regulation 2017/745 (on medical devices, the MDR) and EU Regulation 2017/746 (on in vitro diagnostic medical devices, the IVDR). 

Key Points Defined in the New Regulations

The most essential provisions deal first of all with the information obligations of economic operators on the market of medical devices and in vitro diagnostic devices. At the same time, rules for advertising medical devices are defined. Finally, the law describes the system of administrative sanctions related to non-compliance with the MDR, the IVDR or the law.

Advertising for Medical Devices

Never before had Polish regulation of medical device advertising been established. Now there is. Nevertheless, the term “advertising” is not factually defined. Advertising aimed at the general public must contain understandable language so that even a layman can know what it is about.

What is Not Allowed in Medical Device Advertising?

A number of rules have been laid down stating what is not allowed. First of all, it is not permitted to show an image of someone who practices or claims to practice, a medical profession. This also means that the presentation of the product in question may not be done by a medical professional. Similarly, the suggestion of such a professional is also prohibited.

In addition, the advertising must not be aimed directly at children. This group may in no way be urged to buy the product itself, nor persuaded others to do so. Furthermore, the advertisements may not relate to specific professional devices. It may only be about medical devices used by laymen.

Finally, Article 7 of the MDR and Article 7 of the IVDR lay down some additional proscripts. These deal with claims made in relation to the medical device. The new Polish law now states that advertising must not violate the rules as laid down by these two articles.

What is Required to be Stated in Medical Device Advertising?

There are two things that every advertisement must contain at least. First, of course, there is the name or trade name of the product. Next, it is mandatory to describe the intended use.

The Minister of Health is going to draft another supplementary regulation. This will not only include detailed regulations regarding the necessary information in advertisements. They will also include the manner in which advertisements should be made.

Further Provisions on Advertising

In summary, the new regulations also provide guidance on a number of issues. For example, it answers the question of who may advertise medical devices. Furthermore, the law defines, among other things, who is responsible for advertising. In addition, the new regulations also lay down to which other advertising-related activities the described provisions apply.

Violators

Measures can be taken if the rules are violated. This may involve correcting the violation or stopping the publication. The public publication of a correction can also be a measure.

Register of Distributors

There will be a national register of distributors. These are the companies that market devices, systems and procedure packaging located in Poland. The first time this happens, the distributor has to apply to be on the list. That application is made by the dealer to the president of the URPL. In Poland, this is the agency for the registration of medicines, medical devices and biocides.

As well as explaining the registry and where a distributor can submit their registration, the rule also provides guidance on what a request must meet.

Administrative Fines

When the law is violated, a fine can be imposed. In the worst case, this can be as much as 1.1 million euros. On the other hand, there are also provisions that allow the penalty to be mitigated.

When do the Law and the Additional Provisions Enter Into Force?

These Polish national regulations are valid as of May 26, 2022. There is also the part of the supplementary provisions concerning the advertising of medical devices. It is expected that this part will come into effect on January 1, 2023.

Finally, there is a part that frames the provisions on the registration of devices and market participants. That part is expected to take effect on July 1, 2023.

Conclusion

The medical device industry continues to undergo significant changes. We are nearing the end of the legislative process for Poland’s new medical device law will radically change the current environment for doing business in Poland’s medical device sector. 

Polish Medical Device Law Renewed, Links and Downloads

• Medical Devices Act of Poland
• Form for applying for a license to manufacture or import medicines 

Related articles that may interest you:

• EU Notified Body Medtech Services and How to Overcome the Urgent Shortage: a View from 3 Experts
• EU MDR 2017/745 What Changed?
• Irish NSAI Expects Approval to get EU MedTech Certification

The post Polish Medical Device Law Renewed appeared first on cemarking.net.

There are new proposals published for UK guidance for businesses in regard to the designated standards of 

• Personal Protective Equipment,
• Pressure Equipment, and
• Recreational Craft.

The UK OPSS updated their guide on 22 April 2022. This guidance applies to businesses supplying goods on the Great Britain and Northern Ireland markets. 

The documents above are suggested changes to the lists of standards that companies can use to demonstrate that their products, services, or processes conform with the relevant GB law’s key requirements.

A designated standard is a consensus-based standard that BSI proposes and that is recognized by the government, in part or in full, by posting its reference on GOV.UK in a formal notice of publication.

OPSS Commitment

The OPSS is committed to giving stakeholders the chance to object to designation if they have cause to believe that a standard proposed for designation does not completely or partially meet GB key legal requirements. 

Proposals for new or revised notifications are made publicly available on the official website for 28 days (unless immediate action is necessary), during which time interested parties may object to a publication proposal by emailing designatedstandards@beis.gov.uk an objection form. The objection must explain why the standard proposed for designation does not, in whole or in part, meet GB key legal requirements.

Links and Downloads:

• UK Official Government Website
• Designated standards: new or amended notices of publication

Some of the earlier UK and EU published updates 

UK updates or proposed amendments:

• UK Guidance for Businesses on How to Notify Hazardous Products
• UK Guidance for Market Surveillance Authorities

EU updates or proposed amendments:

• EU MDR 2017/745 What Changed?
• Amendments Machinery Directive 2006/42/EC
• Amendments EMC Directive (2014/30/EU)
• MDCG Addition to IVDR to-do List
• EU Proposal: New Harmonized Standards for the Marketing of Construction Products

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Three well-known notified body experts discuss how they are trying to make the new regulatory framework work as demand for EU notified body Medtech services rapidly outpaces capacity. Last week, Amanda Maxwell from Medtech Insight published an article in which the 3 experts address the issues.

Notified Bodies in the Spotlight

As manufacturers struggle to comply with the new Medical Device and IVD Regulations on time, notified bodies are continuously in the spotlight. When it comes to implementation, they are the cornerstones. As the pressures mount and they must adjust to the extra work that new structures and documents entail, these critical structures are bearing the burden of handling the missing components of the new medtech regulatory framework.

Three Experts Give Their Views

Representatives from three EU notified bodies described how MDR and IVDR will fail to perform as intended unless notified bodies have the competence and instruments to carry out their responsibilities. They outlined what the European Commission and other regulators must do to assist them in better performing their critical jobs.Because of the high demand for their services, each notified body must carefully consider whether it can accept each MDR/IVDR conformity assessment request.

The Expert From BSI

Manufacturers with existing BSI certificates for the Medical Devices Directive (MDD) or the Active Implantable Medical Devices Directive are given priority by BSI (AIMDD), According to Medtech Insight, Graeme Tunbridge, now senior vice president of global regulatory and quality, medical devices at BSI, In other cases, he said, BSI may have to make “the difficult decision” not to take on new manufacturers until it is certain it has enough resources.

He forecasted that as demand develops over the next two years, the situation will get more difficult, particularly for the assessment of legacy devices that are still on the market and certified against applicable medical devices regulations.

Tunbridge, who was the former head of devices at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and was instrumental in shaping the new EU regulations during his time there, added that BSI is working with clients to ensure that MDR applications are submitted as soon as possible, because “timely submission of documentation is a critical aspect of ensuring as smooth a transition as possible.”

The Expert From TüvSüd

TÜV SÜD is also approaching capacity constraints, according to Andreas Stange, VP of the medical and health services group at the German recognized organization. For the time being, if his notified body is unable to accept applications immediately, he stated, he will work with manufacturers to establish a submission timetable based on the availability of specialists and the area.

So that’s the current position. However, the German notified body anticipates a severe lack of evaluation capacity beginning next year because the rate of MDD certifications being replaced with MDR certificates is still much too low. This is true for all product categories, according to Stange. Like BSI, the German notified body is pushing all manufacturers to organize their submissions ahead of time “so it can complete the transition in time and avoid any unforeseen surprises” he said.

The Expert From IMQ

Meanwhile, Daniele Bollati, medical devices lead auditor and laboratory specialist for Italy’s IMQ, noted that his notified body, as a medium-sized participant, has capacity but is taking longer to perform the tasks.

“We are aware that we can’t guarantee our [existing] MDD customers that they will be all certified under the MDR in time; it is currently not feasible in terms of man-hours required,” he said. IMQ is trying to increase, or reallocate, resources to manage the workflow.  

EU Notified Body Medtech Services Shortage | Photo source: The This is Engineering image library on Unsplash

Recruitment And Logistics

Despite considerable expenditure over at least half a decade, all three notified bodies continue to seek for new talent due to the high level of demand.

TüvSüd today has around 800 medtech professionals, with the company growing at a pace of about 20% per year over the last four to five years. In a similar time frame, BSI has nearly quadrupled its technological and clinical resources.

Unfortunately, due to the large additional requirements of the new regulations and other restraints, like as the impact of the COVID-19 epidemic, this does not equate to a fivefold increase in capacity, according to Tunbridge.

Despite this, BSI has been able to add new manufacturers as a result of its expansion.

The Importance of Good Recruitment Strategies

All three notified bodies are aiming to hire more people and are aware of the importance of good recruitment strategies, but Stange and Tunbridge both mentioned the limited talent pool that everyone participating in the regulatory system is hoping to tap into. There is also, of course, a large amount of time spent training staff to be competent in conformity assessment work.

Personnel concerns, according to Bollati, are one of the most important issues confronting notified bodies right now. In his opinion, a change of the NBOG 2017-2 guidance paper regarding qualification standards, particularly for the clinical section, would be beneficial. Bollati also feels that shortening the on-site audit length for the first certification operations (particularly for legacy equipment) could free up more notified body time.

Shortage of Auditors

Bollati’s concern about a shortage of auditors was mirrored by Stange, who claimed that a condensed program of two years of professional experience in each product area should be adequate to qualify.However, he was quick to point out that even this would not be enough to handle the workload of notified bodies in 2023/24, despite the fact that it would certainly help IMQ make better use of its existing resources, as would hybrid audits and a more consistent interpretation of Medical Device Coordination Group (MDCG) documents, he said.

IVD Regulation

All three notified bodies are concerned about the slow pace of notified body designations under the IVDR, arguing that this creates additional work for those notified bodies that have already been designated and jeopardizes some companies’ ability to transition from the Directive to the Regulation on time.Under the IVDR, both BSI and TÜV SÜD are recognized. According to Bollati, IMQ was not previously classified under the IVDD but is in the process of being designated under the IVDR.

‘Steep Learning Curve Ahead’

Experts expressed relief that the IVDR has extended the deadlines for many legacy devices. However, Tunbridge pointed out that when manufacturers begin to grasp the level of technical, clinical, and performance information that will be necessary to satisfy notified body evaluations, “a particularly steep learning curve” ahead. Nevertheless, he is hopeful that the revised IVDR deadlines will allow BSI to hire new IVD makers following the IVDR application deadline in late May.

Large Notified Bodies’ Assistance for Smaller Bodies

With the IVDR, both BSI and TüvSüD are assisting other recognized entities. TüvSüD is supporting other notified organizations in their preparation for designation by giving training, contributing to position papers, and making recommendations to the commission on how to improve the regulatory framework. Furthermore, BSI is investigating how larger notified bodies with more experience in this area might assist smaller or new notified bodies.

However, Tunbridge reiterated that there is “no quick fix.”

Added IVDR Challenges

Because so many manufacturers would be engaging with notified organizations for the first time, the outlook for conformity assessment timescales under the IVDR is more uncertain than the MDR, according to Tunbridge.

In the IVD space, Stange expressed “special concern” over the sluggish adoption of essential guidance documents, implementing rules, and standard specifications. According to Tunbridge, the appointment of EU reference laboratories is also taking a long time, and the delays will have an influence on the supply of the highest-risk IVDs.

“All this contributes to an increased IVDR workload for notified bodies and further reduces the limited assessment capacity,” Stange warned.

2026 And 2027 Squeeze

The new transition periods, according to Stange, will provide much-needed relief and help to spread the assessment burden over the coming years; however, the significant decrease in IVDR notified body applications is likely to result in serious capacity issues for designated IVDR notified bodies when the transition periods end in 2026 and 2027.

Figures from MedTech Europe indicate that for about 70% of all devices on the market, i.e., class C and B devices, the transition will fall in this period, he added. Moreover, when it comes to class D high-risk devices, Stange said, “we anticipate that the EU reference laboratories will not cover the full range of these devices so we will need to implement our own approach to batch verification for some device types.” 

These are difficult challenges, he concluded.

Remote And Hybrid Audits

Remote audits are one option that could assist speed up auditing under the new requirements by reducing travel time for notified entities and complicating scheduling.

However, because the future legal status of virtual and hybrid audits (which combine in-person and remote auditing) is unknown, BSI is returning to in-person audits wherever possible (although on a case-by-case basis as restrictions remain in some countries). 

‘Boots on the Ground’

For many aspects of auditing, there is “no substitute for getting boots on the ground and visiting a manufacturer in-person,” Tunbridge acknowledged. But he emphasized that BSI’s experience shows that it is possible to combine in-person auditing with simultaneous remote auditing for certain processes. This is particularly the case for practices that are non-physical in nature and mainly documentation based, such as quality management system records, he said.

“Not only is this a more efficient use of resources, but it also allows us to draw on a wider range of expertise to support the audit. It also supports one of the tenets of new legislation in increasing transparency as it means that a regulatory authority can easily witness an audit undertaken anywhere in the world,” he said.
With notified bodies’ resources stretched and more expertise in remote auditing gained during the pandemic, Tunbridge believes hybrid auditing has the “greatest potential moving forward.”

Bollati shared this sentiment, saying that notified bodies are asking the commission for a rule modification to allow hybrid audits on a larger scale in the context of the new legislation, not least because of the environmental and resource-saving benefits they provide.

While TüvSüD has returned to in-person audits conducted by its local specialists, the pandemic has made it more difficult to hire experts from other countries.

TüvSüD prefers hybrid audits, in which an on-site team is aided by a remote specialist, he said. This has shown to be highly effective in our experience. According to Stange, fully remote audits are becoming increasingly unusual.

He, too, agreed that “existing legal restrictions make them complicated and only viable in unusual instances.” Above all, Stange wants “a standard and consistent strategy across the EU allowing notified entities to perform hybrid audits.” According to Stange, who is located in Japan, travel within China is challenging, and organizing audits is tough owing to the frequently shifting pandemic situation.

MDCG Documents

Tunbridge is also concerned about keeping BSI’s teams up to date with the European Commission’s MDCG’s tens of thousands of pages of guidance. While clarity on the member states and the commission’s goals is welcome, he believes there is a risk of overburdening those who must execute the recommendations.

As deadlines approach, working on the critical concerns that will support patient access to high-quality, safe products becomes increasingly crucial, he said.

The main problem, according to Stange, is the inconsistent interpretation of MDCG advice materials by responsible authorities, which leads to time-consuming conversations with firms concerning their implementation. He’d want to see a unified approach to setting realistic implementation timelines for these guideline materials.

EU Notified Body Medtech Services and How to Overcome the Urgent Shortage: Sources, Links and Downloads

• “Against The Odds: Notified Bodies Pinpoint The Real Obstacles And Ways To Move Past Them“ by Amanda Maxwell from Medtech Insight
• Some of our previous articles you might be interested in:
  • Irish NSAI Expects Approval to get EU MedTech Certification
  • French & German warning: EU must extend MDR transition period
  • MDCG Addition to IVDR to-do List

The post EU Notified Body Medtech Services and How to Overcome the Urgent Shortage: a View from 3 Experts. appeared first on cemarking.net.

The new medical device regulation, EU MDR 745/2017, has several additional criteria in regard to previous legislation. This new regulation also has a stronger connection to EN ISO 13485:2016. What modifications are made to the prior medical device regulation, and how must you implement these changes in your current quality management system?

This article contains important information for manufacturers and distributors of medical devices

To retain your certificates, you must understand the changes and know how to implement them. Firstly, knowledge of the interfaces between EN ISO 13485:2016 and the EU MDR 2017/745 is crucial to comprehend and implement the amendments. Furthermore, you need to understand which elements of EU MDR 2017/745 are not covered by EN ISO 13485:2016. Certificates issued under the existing MDD remain valid. Thus, you can place products on the market for a limited period. However, no significant changes can then be made to the products, the quality system, or the company. There can also be no certificate extensions during this time.

Products destined for the UK market must comply with the UK government’s new product marking UKCA. That went into effect on January 1, 2021. The UKCA transition period for medical devices is currently planned to end on June 30, 2023.

A Bit of History and the Current Actuality

Two new medical device regulations were issued on May 5, 2017, and they took effect on May 25, 2017.

• The Medical Devices Regulation (MDR) has May 26, 2021 as date of application.
• Compliance is required to be permitted to place medical devices on the European market after that date.
• Unless transitional arrangements allow for continuing placement of devices on the market.
• The In Vitro Diagnostic Medical Devices Regulation (IVDR) has May 26, 2022 as date of application.

What is MDR (EU) 2017/745 – Medical Devices Regulation?

1. The Medical Devices Regulation (EU) 2017/745 has taken the place of two previous directives: The MDD (Medical Devices Directive) and the AIMD (Active Implantable Medical Device Directive).2. The IVDR will take the place of the In Vitro Diagnostic Directive (IVDD). Both laws offer lots of significant enhancements to medical device conformity assessment, with the goal of:

• Enhance the quality, safety, and dependability of medical devices sold in Europe.
• Consumers and practitioners should have more access to information on medical devices.
• Increase market supervision and vigilance of devices in use.

EU MDR 2017/745 What Changed and How Will it Affect Your Business?

The impact of these changes on your business will vary. That depends on the sort of product you make and the position you hold (manufacturer, importer, authorized representative). Does your organization aims to achieve compliance with the regulations, then you must expect significant changes to the:

• compliance process;
• quality management system; and 
• technical documentation.

As a stakeholder, you need to successfully implement and certify these changes as relevant to the device classes and roles of your organization. It is vital that you become familiar with the new standards’ requirements as soon as possible. So that you can plan for a smooth transition.

EU MDR 2017/745 What Changed? Quick Overview of Key Differences

The revisions to the MDR and IVDR are frequently mistaken as a revision of the requirements. On the contrary, it is actually new legislation that should be treated as such.In general, the current legislation maintains the MDD and IVDD principles and requirements. But in addition to that, there are number of new requirements that manufacturers need to address before an application for certification to the MDR and IVDR can be made. 

#1 The Technical Documentation

There is a new structure of the technical file. Also, the level of details from the content of the technical file has changed. The MDR describes in Annex II and III specifically what must be included in any documentation. Previously the MDD specified comparatively little in terms of content, the MDR now tightens up and even goes a step further by specifying criteria for a TD on post-market surveillance.

#2 Establishment of Compliance with ”General Safety and Performance Requirements”

With the implementation of the new EU Medical Device Regulation (MDR 2017/745), the ‘Essential Requirements’ of the MDD and AIMDD will become superseded by the new EU MDR General Safety and Performance Requirements (GSPRs). 

#3 Requirement for a ”Person Responsible for Regulatory Compliance”

Under the new regulation, you require a ”Person Responsible for Regulatory Compliance”. He or she must be appointed within the manufacturer (Article 15 of the MDR). It intends to ensure companies have a qualified regulatory expert at their disposal.

#4 New Procedures Concerning Information Databases

New regulations implement new or revised procedures to handle new requirements. This includes entering information into the databases, such as Eudamed.

#5 Strengthened Requirements for Post Market Surveillance

There are strengthened requirements for post market surveillance. Moreover, the requirements for clinical evaluation, post market follow up and clinical investigations (Annex III XIV & XV) are also strengthened. It should be noted that the processes for post market surveillance/post market clinical follow up should implemented as soon as possible. This is because the data generated will be very useful for documenting compliance to the new requirements when you apply for MDR or IVDR.

#6 Requirement for ”Summary of Safety and Clinical Performance”

The Summary of Safety and Clinical Performance (SSCP) is a new requirement under the EU MDR (applicable to Class III and implantable devices). The basic requirements for the SSCP are described in Article 32 of the EU MDR. Further guidance was issued by the Medical Device Coordination Group (MDCG) in August 2019: MDCG 2019-9 Summary of safety and clinical performance – A guide for manufacturers and notified bodies.

Although the MDCG guidance is careful to distinguish between requirements and recommendations it represents current best practice, and regulators will look for conformity with all of its recommendations. This White Paper explains the purpose and contextual background of the SSCP and summarizes the key requirements and recommendations from the MDR and MDCG 2019-9 guidance.

#7 Changes to the Classification Rules

The conformity assessment system, as we know it from the MDD, is generally upheld. Even though there are changes to the classification standards. Some products have been assigned a higher class, necessitating a more rigorous conformity assessment process (for example, some products that used to be IIb are now class III and thus subject to a design examination.) Furthermore, the notified body’s assessment procedure has become more complex, with heightened scrutiny, particularly for class III and IIb implants and infusion devices.

#8 Implementation of Unique Device Identifier (UDI)

One of the new things that come with the new EU MDR 2017/745 and IVDR 2017/746 is the introduction of the UDI. More specifically, it is a Unique Identification Number Europe, as there is also one in the USA. This element will be key for the traceability of devices in Europe.

New Certification Audit

The Notified Body will need to perform a new certification audit of your organization once it has been implemented. The certification procedure begins with a new certification application and closes with a new certificate that is valid for up to 5 years. Assessment of technical files (Class IIa, IIb), evaluation of the design ( Class III ), inspection of the quality system for compliance, and finally an on-site audit where compliance is validated are all part of the certification process. If the manufacturer outsources important tasks or relies on key suppliers, an audit of these parties may be required before the certification procedure is completed and the certificate awarded.

EU MDR vs. ISO 13485

First of all, it is important to note the difference between these two frameworks. In a nutshell, the EU MDR outlines what you must do in order to manufacture medical devices for the European Union market. Whereas the EU MDR only applies to companies who sell medical devices within the EU, ISO 13485 is applicable to any company anywhere in the globe.

MDR EU 2017/745

The EU MDR is a law issued by the European Union that specifies what an organization must do in order to manufacture or import medical devices into the EU. This legislation specifies how medical devices must be labeled and certified. Also, it specifies revisions on what information must be given to the Eudamed database.

EN ISO 13485:2016

On the other hand, ISO 13485, is a globally recognized platform for the development of a quality management system for medical device companies. Any company that demonstrates it develops medical devices and provides related services that consistently meet consumer and regulatory criteria can employ ISO 13485 requirements. 

How ISO 13485:2016 Helps With EU MDR Compliance

The EU MDR outlines the minimum requirements that need to be included in a QMS. All of these are also covered in the ISO 13845. The QMS requirements, described in article 10 of the EU MDR, are listed here below. Behind each description you can find the exact clause that covers that specification in the ISO 13485.

• “A strategy for complying with regulation” is also covered in ISO 13485, clause 4.1
• “Safety and performance”  is also covered in ISO 13485, clause 7.5
• “Management responsibility”  is also covered in ISO 13485, clauses 5.1 and 5.5
• “Resource management”  is also covered in ISO 13485, clause 7.4
• “Risk management”  is also covered in ISO 13485, clause 7.3
• “Clinical evaluation” is also covered in ISO 13485, clause 7.3
• “Product realization” is also covered in ISO 13485, clause 7
• “Verification of Unique Identity assignment” is also covered in ISO 13485, clauses 7.5.8 and 7.5.9
• “Post-market surveillance system” is also covered in ISO 13485, clauses 8.2.1 and 8.2.2
• “Communication with authorities” is also covered in ISO 13485, clause 8.2.3
• “Incident reporting” is also covered in ISO 13485, clause 8.2.3
• “Corrective and preventive actions” is also covered in ISO 13485, clauses 8.5.2 and 8.5.3
• “Monitoring and measurement, data analysis and product improvement” is also covered in ISO 13485, clause 8.2

EU MDR 2017/745 What Changed? And is ISO 13485 mandatory for MDR?

The short answer is that ISO 13485 certification is not required for EU MDR compliance. However, despite the fact that the EU MDR law does not specifically mention ISO 13485, it does require that you have a QMS in place. The EU has produced a list of harmonized standards to aid firms in understanding all of the standards that apply to medical devices in the EU, and the ISO 13485:2016 standard is the only QMS standard indexed on this list — as a result, most companies utilize ISO 13485 to execute their QMS.

Furthermore, It’s worth noting that the EU MDR regulation isn’t aiming to replace ISO 13485 as a QMS standards document. The EU MDR legislation specifies specific processes for medical devices. Moreover, the ISO 13485 standard is meant to be an all-encompassing set of interrelated regulations that establish internationally recognized best practices for a medical device manufacturer. When you construct your QMS following the ISO 13485 criteria, you can assure that not only do you have an excellent system for your medical devices. But also, you have a system that meets the EU’s authorized QMS standard.

EU MDR 2017/745 What Changed and How Does it Impact a QMS Implemented Using the ISO 13485 Requirements?

Largely, to comply with the EU MDR criteria, more records will be required. For example, ISO 13485 mandates that you keep a medical device file (clause 4.2.3), which must contain a minimum set of data. This documentation, however, will need to include all of the information specified in Annex II of the EU MDR for the medical device technical file in order to comply with EU MDR rules. The EU MDR also necessitates the keeping of additional post-market surveillance and clinical evaluation records. The procedures you use to create, update, and maintain this documentation, on the other hand, will essentially remain unaltered.

Conclusion

Although ISO 13485 is not directly cited in the EU MDR law, it is the only QMS standard listed in the EU list of harmonized standards. This makes it the only reasonable approach to implement a QMS in accordance with the MDR. That is an extra benefit on top of becoming MDR compliant, because ISO 13485 provides a full system dedicated to helping you improve your quality operations. 

EU MDR 2017/745 What Changed? Sources, Links and Downloads

• Getting ready for the new regulations
• Medical Devices Regulation
• In Vitro Diagnostic Medical Devices Regulation
• EN ISO 13485:2016
• Rimsys
• MDCG Addition to IVDR to-do List (BLOG)
• Research and Markets
• DNV Healthcare

The post EU MDR 2017/745 What Changed? appeared first on cemarking.net.

New Legislation

The European Commission must appoint inspectors to conduct assessments and certify devices for use. In fact, they do so according to new legislation. The new In Vitro Diagnostic Regulation (IVDR) regulates devices that use biological samples to make diagnoses. You can think of pregnancy and diabetes tests, for example. It will go into effect next month. It requires the European Commission to appoint inspectors – known as notified bodies – to carry out examinations in order to certify devices for use.

New Criteria

This includes a number of new criteria, such as:

• updated risk-based criteria for evaluating devices, 
• improved communication across member states, and
• more stringent post-market surveillance to track how gadgets are used in practice.

Officially, the laws go into force next month. However, the transition periods for specific devices have been extended by many years, depending on their danger level.

“We’re on schedule for designation this summer, but there’s no specific date yet,” an NSAI spokesman said.

Slow Process of the Selection of Notified Bodies

On the other hand, the medical device sector has criticized the new regulation’s process for selecting notified organizations as being excessively slow. Consequently, there are only six notified bodies as of yet. This raises concerns that there may be a capacity shortage in Europe to certify devices under the new framework. Under the prior rules, there were 19 notified bodies.The IVDR rules will take effect on May 26th, however the European Commission has delayed the transition period, staggered the dates for specific devices, and given some of them a 2028 extension.

“Member states, manufacturers and notified bodies must now use the additional time to build up the necessary capacities, and manufacturers must prepare to transition to the new requirements“.

“There is no time to rest,” EU health commissioner Stella Kyriakides said.  The Medical Device Regulation, which is designated for all other devices, is a sister regulation to the IVDR. 

Irish NSAI Expects Approval to get EU MedTech Certification: sources, links and download

• Jonathan Keane from Independant.ie
• Medical Device New Regulations, Official page from the EU
• Download MDR, available in 24 languages
• French & German warning: EU must extend MDR transition period (Blog)

The post Irish NSAI Expects Approval to get EU MedTech Certification appeared first on cemarking.net.

SNITEM and BVMed are seeking for major changes following a meeting with European Commission representatives in Paris on March 14, 2022. 

Not Enough Notified Bodies

It is clear that the number of Notified Bodies available is insufficient. Therefore it is hard to conduct the required conformity assessments under the new standards. For the most part, this is one of the main difficulties in the transition to a new medical device regulatory framework. As a matter of fact, the current transition is posing significant challenges for manufacturers attempting to comply with the new requirements with their existing medical devices. Reportedly, it is already having a negative influence on health services. This is one of the main issues in the coöperative French & German warning.

Postponement After Postponement

In spring 2020, the European Commission postponed the MDR’s Date of Application (DoA) by a year. The EC acknowledged that there could be severe issues. As the deadline for the IVDR’s DoA approached, the EC was obliged to take a similar action in December 2021. In fact, the EC extended the IVDR transitional periods for most in vitro diagnostic medical devices (IVDs). Obviously that was to give business more time to comply. This came after a powerful statement from key individuals in the European pharmaceutical industry. They warned that vital IVDs for cancer detection would be driven off the market if new conformity assessments could not be secured in time.

Press Release for Joint French & German Warning

Nonetheless, it is obvious that Notified Body capacity is not growing fast enough. It can’t keep pace with the increasing demand for conformity evaluations. In the most recent dramatic turn of events, SNITEM and BVMed issued a press release. At the moment this is only available in French and German. They announced a Franco-German initiative to avert a crisis in patient care. Evidently a crisis caused by a lack of medical device availability under the new framework. Furthermore they urge the European Commission and “other concerned actors” to take immediate action to grasp the situation. The trade groups are concerned about a “collapse” of patient care, according to the news release. Another wake-up call should come in the form of a letter like this from key European industry organisations.

SNITEM and BVMed Call for Changes

Significant expansions to the MDR transitory periods will likely attract the most attention: 

• firstly, two years for Class III and implantable medical devices, and
• secondly, four years for all others. 

Indeed, these proposed measures are there to keep existing medical devices on the European market. This, by taking a “lighter touch” approach to conformity assessment. This is much like granting “grandfathering” to some “old” medical devices. This would be similar to the IVDR’s tapering transitory periods, which were recently amended. Furthermore, the French & German warning calls upon for more changes:

• Expanding the capacity of Notified Bodies through:
  • lowering the time it takes to designate new Notified Bodies,
  • streamlining the Notified Body designation process, and
  • creating incentives for new organizations to become Notified Bodies;
• To conduct conformity checks, make better use of current resources. SNITEM and BVMed aren’t really clear on what this signifies, but they offer a few possibilities:
• Post-market surveillance of “legacy” medical devices could be more “sensible” (at least in the short term); 
• the use of “conditional” conformity assessment certificates, which allow manufacturers to supplement dossiers with post-market data to support conformity; 
• the use of “second look” consultation and scrutiny procedures (in Article 54); and 
• the establishment of specialist rules for niche products (presumably to allow those niche products to be fast-tracked through conformity assessment).

‘Lighter Touch Approach’ to Conformity Assessment

This appears to be the case where SNITEM and BVMed call for more intelligent use of existing resources. 

Will the EU Respond to this French & German warning?

It will be interesting to see how and whether the EU responds to this call to action. Meanwhile, the passing of time continues. In two months, the IVDR’s DoA will arrive. The first anniversary of the MDR’s DoA is near, and the remaining time under its transitional periods is ticking away. We expect this latest intervention by SNITEM and BVMed to result in some form of regulatory leniency from the EU. For this reason, the industry should not abandon its efforts to adapt to the new standards. 

French & German warning: EU must extend MDR transition period: links and downloads

• Bernard Banga from BioWorldAlex Denoon and Jamie Hatzel from Bristows LLPThe MDR explained
• BLOG: EU-MDR Lurches Towards US-FDA Approach
• BLOGPOST: Compliance And The Growth Of The Medical Industry
• BLOG: EU No Longer Priority Market For Medical Device Manufacturers

The post French & German warning: EU must extend MDR transition period appeared first on cemarking.net.

The manual is updated on 14 April 2022. 

This guidance applies to businesses supplying goods on the Great Britain and Northern Ireland markets and sits alongside PAS 7100:2022 on Supporting better product recalls. 

What is the Reason for this Guide?

This guidance is for businesses providing consumer and non-consumer items on the UK market. Basically, it summarizes the requirements for alerting relevant authorities if products pose a risk to consumer or workplace health and safety. Furthermore it explains the procedure if their products are found to be non-compliant with applicable legislation.

Summary of How Businesses Must Notify Hazardous Products

Firstly, the guide starts with establishing the authority of The OPSS. Further, the guide explains what the notification requirements stem from and how and to whom notifications should be made. Subsequently, this guide clarifies to whom it applies.

Why is There Legislation on Product Safety Notification?

The product safety legal framework requires businesses supplying goods on the UK market to notify the relevant authority where they become aware that a product they have placed on the market, supplied or distributed is unsafe and poses a risk to the user, or is noncompliant with the relevant legislation. 

Product safety notifications support:

• The safety of people and the environment, by ensuring that corrective actions and steps are taken to reduce the risks to consumers and users;
• Business, by allowing regulators to provide advice and support to address issues, minimising the likelihood of future noncompliance; and
• Regulators, by recording and sharing information to permit authorities to focus activities on issues and products identified as presenting the greatest safety risks

General Product Safety Regulations 2005

This guide explains in general how the General Product Safety Regulations applies to businesses when their products fail to meet compliance or when they are dangerous.

Sector-Specific Safety Legislation

For some sectors, e.g. the Toys Industry, there is sector-specific regulation. This may differ from the usual regulations. A list of sector-specific safety legislation and references to the legal provisions for notification can be found in Annex A of the guide, including the relevant authority for each regulation and circumstance.

Northern Ireland

If a product sold on the Northern Ireland market is found to be unsafe, this must be reported to the relevant authority who will share this information with OPSS via the Product Safety Database. Individual EU Member States may have specific arrangements in place for notifications where a product that does not meet the safety requirement has been supplied on their markets. You should seek confirmation within each Member State you supply products to regarding product safety notifications and may wish to make use of the EU Product Safety Business Alert Gateway system

What’s More?

Furthermore, the guide includes the following:

• Notifications – the role of Market Surveillance Authorities and Enforcement Authorities
• Other Statutory Product Notifications to OPSS
• Legal Metrology;
• Restriction of Hazardous Substances (RoHS): and
• Serious Undesirable Effects (Cosmetics)

UK Guidance for Businesses on How to Notify Hazardous Products: Links and Downloads

• UK General Product Safety Regulations 2005
• Product Safety and Noncompliance Notification Guidance for Business
• PAS 7100:2022 on Supporting better product recalls.
• Product Safety and Noncompliance Notification Form
• EU Product Safety Business Alert Gateway system
• Product Safety Alerts, Reports and Recalls site
• OECD Global Recall Portal
• EU Toys Safety Directive explained
• Making sure of complete European compliance, including the UK

The post UK Guidance for Businesses on How to Notify Hazardous Products appeared first on cemarking.net.

This manual is updated on 14 April 2022. 

What is the Reason for this Guide?

It provides market surveillance authorities information on how they must use the PSD to report unsafe and noncompliant products. PSD stands for Product Safety Database. Basically, it is a directory used for reporting unsafe and noncompliant products.

Summary of UK Guidance for Market Surveillance Authorities

This guidance is intended for market surveillance and enforcement authorities in the United Kingdom who are responsible for product safety and legal metrology regulation. It specifies the need to notify the Secretary of State if items endanger consumers’ health and safety. Furthermore, it outlines the requirement to notify the Secretary of State when products are found to be noncompliant with the relevant product safety legislation.Subsequently, this guide clarifies to whom it applies and how notifications should be made. Furthermore, it provides related authorities transparency on how the OPSS will take legal action following notification on the PSD. 

What’s More?

In short, the guide includes the following:

• Legal requirements to notify product safety risk and noncompliance
• General Product Safety Regulations 2005.
• Regulation on Accreditation and Market Surveillance (Great Britain)
• EU Regulation on Market Surveillance and Compliance (MSC) of Products (Northern Ireland) .
• Sector-specific legislation
• Notifying the Secretary of State using the PSD (the role of the Market Surveillance Authority
• Post-Notification Actions and Requirements (the Role of OPSS)
• Validation of Product Safety Notifications 
• Publication of Alerts
• International Reporting and Market Surveillance Data Exchange
• Additional UK Product Safety Contact Point functions
• Overseas Liaison and Engagement
• International surveillance
• Domestic Surveillance

UK guidance for Market Surveillance Authorities, links and downloads

• Official OPSS page
• Product Safety and Noncompliance Notification Guidance
• Access the PSD
• Read information on serious undesirable effect (SUE) and safeguarding notifications for cosmetics
• MDCG Addition to IVDR to-do List

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This is the thrust of the series of publications that the British government started on 29 March 2019. These announcements return on a very regular basis and they have only one reason: to keep consumers safe. 

We fully support this initiative, hence our attention to these posts.

Consumer Protection and Advice: Things to Consider When Buying and Using Products

Product safety regulations protect you from harm caused by the items you own or use at home or while outdoors. You may, however, take practical precautions to protect yourself and your family. Let’s go through a few important steps that consumers can take to keep their consumption as safe as possible:

1. Check Before You Buy: What to Think About When Shopping

Firstly, you need to think carefully about who and where you are buying from. 

While the internet has made it much easier to get a product delivered to your door, this, too, involves a risk. If you buy it from a seller outside the UK, there’s a danger it wasn’t made or labeled in compliance with our safety rules.

Take a moment to examine any merchandise you’ve purchased. Are there any warning labels on it? And furthermore, are the directions easy to understand? Do you know the manufacturer’s name and address? If not, these could be red flags. When utilizing the product, exercise caution. Furthermore, when purchasing secondhand items, you must also exercise caution. If the instructions are missing, the manufacturer’s website may provide them. 

When you want to buy electrical products online you need to pay extra attention.  Electrical Safety First, an initiative from the UK government, provides very good and specific details on what to do. In fact, underneath in the “links and downloads-“ section, you can find the link to their website.

1.a. Marking

Some products must bear the necessary labeling or else they may not be sold in the UK. This is a manufacturer’s statement that the product complies with particular safety, health, and environmental standards.

Toys, electrical goods, gas appliances, fireworks, and personal protection equipment such as goggles, gloves, and helmets are examples of products that fall under this category. Only buy these types of products if they are clearly marked and have the manufacturer’s name and address on them.

Until 1 January 2023, products sold in Great Britain may display:

• CE marking, or
• UKCA marking, or
• UKCA marking and CE marking, or
• UKNI marking and CE marking

Products sold in Northern Ireland may display:

• CE marking, or
• UKNI marking and CE marking

2. Register Your Products

Many household devices, particularly those that are electrical, have the option of being registered with the manufacturer. This is commonly done to activate an extended warranty or guarantee, but it is also crucial for safety reasons.

By registering your product, you will be notified immediately if there is a safety issue with it, and you will be able to get any necessary repairs completed as soon as feasible. If it’s recalled, you’ll get a refund or a replacement.

To register a product, go to the manufacturer’s website, find the registration page, and fill out and submit the form. In fact, underneath in the “links and downloads-“ section, you can find the link to a page called “Register my appliance”. You might also be able to register via phone or mail. Both new and used products are eligible for registration.

If you don’t register, you risk unintentionally using dangerous products.

3. Examine the Instructions and Follow Them to Optimize Consumer Protection and Advice to Stay Safe

The instructions that come with products are designed to help you use them safely. Therefore it’s important to read and follow them.

For example:

• cleaning fluids should be securely stored in cupboards, well out of reach of children;
• heavy furniture should be attached to the wall to avoid it tipping over;
• fridge freezers need to have enough room behind them for air ventilation.

Detailed product safety information on specific types of products is available from the Royal Society for the Prevention of Accidents (RoSPA). In fact, underneath in the “links and downloads-“ section, you can find the link to their page. 

4. What to Do if Your Product Has a Potential Safety Risk

Consumer products are the responsibility of all businesses that manufacture, import, distribute, or sell them in the United Kingdom.

If a company discovers that a product it has sold poses a safety concern, it must take steps to address the problem. This could include giving customers new instructions, changing the product, or ordering them to cease using it and return it for a refund. The maker must notify all of the consumers who are known to be affected by the problem and inform them of what they should do.

If you receive an email or letter from a manufacturer with the words ‘Important Safety Warning’ or ‘Product Recall’ displayed, you should:

• check if it relates to a product you own
• take any actions it recommends
• get answers from the website shown on the notice if you have questions, or by calling the manufacturer, whose number should be provided in the letter or email

5. What to Do if You Are Concerned About the Safety of a Product

If you are concerned about the safety of a product, contact the consumer helpline to Citizens Advice in England or Wales or to Advice Direct Scotland. The links to their webpages are in the section underneath this post. Your complaint may be referred to the relevant local Trading Standards service, who may take further action.

You may be entitled to a refund, a replacement or a repair if there is a safety issue with a product you own, but not if you have damaged or misused it.

6. What to Do if a Product Causes Injury or Damage

Depending on the circumstances, you may be able to seek compensation if an unsafe product causes injury to you or your family or property damage. For more information, call Citizens Advice in England and Wales or Advice Direct Scotland’s consumer helpline. In fact, Citizens Advice can also provide information on how to file a claim for compensation. 

Consumer Protection and Advice for Staying Safe: things to consider when buying and using products in the UK: Links and downloads

• Electrical Safety First
• Register my appliance
• Royal Society for the Prevention of Accidents (RoSPA)
• Citizens Advice (for England & Wales)
• Advice Direct (for Scotland)
• Product Safety Alert (Recalls and other information about hazardous products)
• Product Recalls and Alerts (UK government page about recalls and alerts)
• Consumer Rights (after their product  has been alerted on safety issues or when it is recalled).
• Toys Safety Directive (2009/48/EC) explained (example of European regulation for producers and manufacturers)

Find information on the safety of other products

Finally, the safety of some consumer products is the responsibility of specific agencies:

• Workplace products are covered by the Health and Safety Executive (HSE)
• Foods are covered by the Food Standards Agency (FSA)
• Drugs and medical devices are covered by the Medicines and Healthcare products Regulatory Agency (MHRA)
• Vehicles and vehicle parts and accessories are covered by the Driver and Vehicle Standards Agency (DVSA)

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On March 18, 2019, the EC also published amendments to the Machinery Directive. That was Implementing Decision (EU) 2019/436 as regards harmonized standards for truck mixers, cranes and other machinery.

The current changes regard to Article 1 of decision (EU) 2019/436 and the Annexes I, II, III and IV. 

It will be known as Implementing Decision (EU) 2022/621.

Most decisions took effect on April 7, 2022. There are however, some exemptions:

• Points (1), (4), and (6) of Annex I shall apply from 11 October 2023.
• Point (3) of Annex I shall apply from 19 March 2019.

Addition to Article 1 of Implementing Decision (EU) 2019/436

In this article, the following paragraph is added:

‘The reference of harmonised standard EN 474-1:2006+A5:2018 for Earth-moving machinery drafted in support of Directive 2006/42/EC, listed in Annex IIA to this Decision, is hereby published with restriction in the Official Journal of the European Union. That reference shall be deemed to have been published in the Official Journal of the European Union for the period set out in that Annex.’

Changes to Annexes I, II, III and IV of Implementing Decision (EU) 2019/436

There a several amendments to these addenda. Some rows in the tables have been deleted, whereas others have been inserted or replaced. All amendments are categorized in one good overview. You can find this here. Accordingly, this link refers to the official EU-page with regards to the latest implementing decision.

Amendments Machinery Directive 2006/42/EC: links and downloads

• Machinery Directive (2006/42/EC) explained
• Harmonized Standards on the Machinery Directive 2006/42/EC – Official Journal
• COMMISSION IMPLEMENTING DECISION (EU) 2019/436 of 18 March 2019
• COMMISSION IMPLEMENTING DECISION (EU) 2022/621  of 7 April 2022

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Do you have applied standards to prove compliance with the aforementioned directive? In that case we recommend you to check the new list of standards to see if any of the standard you applied have been updated, or whether there are new standards available for your products.

When standards have been updated by this list, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity.

On August 5, 2019, the EC also published amendments to the EMC Directive. That was Implementing Decision (EU) 2019/1326 as regards harmonized standards for electromagnetic compatibility.

The current changes regard to Annexes I and II of the Implementing Decision 2019/1326.
  
It will be known as Implementing Decision (EU) 2022/621.

In Annex I to Implementing Decision (EU) 2019/1326, new entries are added

• No 16, EN IEC 62053-21:2021
  • Electricity metering equipment – Particular requirements – Part 21: Static meters for AC active energy (classes 0,5, 1 and 2)
  • EN IEC 62053-21:2021/A11:2021

• No 17, IEC 62053-22:2021
  • Electricity metering equipment – Particular requirements – Part 22: Static meters for AC active energy (classes 0,1S, 0,2S and 0,5S)
  • EN IEC 62053-22:2022/A11:2021

• No 18, EN IEC 62053-23:2021
  • Electricity metering equipment – Particular requirements – Part 23: Static meters for reactive energy (classes 2 and 3)
  • EN IEC 62053-23:2022/A11:2021

• No 19, EN IEC 62053-24:2021
  • Electricity metering equipment – Particular requirements – Part 24: Static meters for fundamental component reactive energy (classes 0,5S, 1S, 1, 2 and 3)
  • EN IEC 62053-24:2022/A11:2021

• No 20, EN 61009-1:2012
  • Residual current operated circuit-breakers with integral overcurrent protection for household and similar uses (RCBOs) – Part 1: General rules.
  • EN 61009-1:2012/A13:2021’

In Annex II to Implementing Decision (EU) 2019/1326, new entries are added

• No 14, EN 62053-21:2003
  • Electricity metering equipment (a.c.) – Particular requirements – Part 21: Static meters for active energy (classes 1 and 2)
  • Date of withdrawal: 13 October 2023

• No 15, EN 62053-22:2003
  • Electricity metering equipment (a.c.) – Particular requirements – Part 22: Static meters for active energy (classes 0,2 S and 0,5 S)
  • Date of withdrawal: 13 October 2023

• No 16, EN 62053-23:2003
  • Electricity metering equipment (a.c.) – Particular requirements – Part 23: Static meters for reactive energy (classes 2 and 3)
  • Date of withdrawal: 13 October 2023

• No 17, EN 61009-1:2012
  • Residual current operated circuit-breakers with integral overcurrent protection for household and similar uses (RCBOs) – Part 1: General rules.
  • Date of withdrawal: 13 October 2023

Amendments EMC Directive (2014/30/EU): links and downloads

• EMC Directive (2014/30/EU) explained
• Harmonized Standards on the EMC Directive (2014/30/EU) – Official Journal
• COMMISSION IMPLEMENTING DECISION (EU) 2019/1326 of 5 August 2019
• COMMISSION IMPLEMENTING DECISION (EU) 2022/622 of 7 April 2022

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Introduction

The Medical Device Coordination Group is responsible for fundamental issues in the medical device industry. The issues range from Notified Body monitoring and standardization to market surveillance. Related international problems, innovative technology, and clinical research are also within the range of their focus. Its expertise originates from its division into 13 subgroups, which respectively provide advice and draft guidance on their expertise field.

The members of the subgroups are appointed by the Member States for a duration of 3 years. Stakeholders participate as observers and are appointed following a call for applications procedure also for a duration of 3 years. They meet regularly with the EU Commission as Chair. It is the MDCG addition to the IVDR to-do list and Eudamed that we discuss in this article.

Why Is the Section on Older Devices Updated?

There is a need for guidelines on what will happen in May 2022. Therefore, the MDCG has amended its joint implementation and preparedness plan for the In Vitro Diagnostic Regulation (IVDR). This includes sections on older devices and Eudamed.

The EU is implementing IVDR in stages. It means that more tests will become legacy devices than were initially envisaged. Legacy devices are goods that were put on the market under the previous directive. The IVDR mentions legacy device regulation, but MDCG believes the “wording of this paragraph is rather general.” This necessitates a clarification of the particular regulations that would apply to older devices beginning in May 2022.

MDCG has added fresh guidance to its list of priority activities in this regard. The goal is to cover the application of IVDR requirements to legacy devices in the same way that MDCG covered the Medical Device Regulation (MDR).  This guidance is still in the consultation stage. However, it is expected to be released in the second quarter of 2022, according to MDCG.

Why Is the Section on Eudamed Updated?

In addition to the update of the section on Older Devices, a new paragraph on Eudamed has been included. Because the Eudamed database will not be completely functional until May 2022, IVDR will not make use of the system mandatory or enforceable. “Guidance on harmonized administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional,” MDCG concluded.

What Is the Objective of these Updates?

Member states and other stakeholders will be able to “meet their obligations under the IVDR effectively while minimizing any potential additional burden on the parties concerned.” The committee is primarily concerned with “cases where the exchange of information would be difficult, or even impossible, to achieve in absence of guidance.” With this in mind, the advice is in the consultation stage and has a second-quarter timeframe.

New priority actions on advice for notified bodies, performance evaluation, and expert panels have been included in the amended IVDR. The second and third quarter timeframes are being worked on for the two texts. 

MDCG Addition to IVDR to-do List: sources, links & downloads:

• MDCG Update
• Nick Paul Taylor from RAPS
• Medical Devices Directive – 93/42/EEC
• Active Implantable Medical Devices Directive – 90/385/EEC
• Regulation (EU) 2017/746 on Wikipedia 
• MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
• EUDAMED
• In vitro diagnostic medical devices and repealing Directive 98/ 79/ EC and Commission Decision 2010/ 227/ EU, Official Journal of the European Union

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RoHs, a quick overview

The regulation on Restriction of Hazardous Substances lays down rules on the restriction of the use of hazardous substances in electrical and electronic equipment (EEE). It is designed to contribute to the protection of human health and the environment. Consequently, this includes the environmentally sound recovery and disposal of waste EEE. If you produce, import, or distribute electrical and electronic equipment (EEE) for the UK market, you must ensure that levels of certain hazardous substances and chemicals are not exceeded.

Numerous types of electronics (EEE) are regulated in the United Kingdom and Northern Ireland to restrict the quantities of dangerous substances and chemicals they contain, with the goal of safeguarding human and animal health. All products included in the scope must:

• demonstrate compliance, and have supporting technical documentation (commonly referred to as a technical file);
• have a Declaration of Conformity;
• labeled with the required information; and
• display the appropriate conformity marking for the GB and/ or NI markets as appropriate

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (as amended) are the underpinning legislation. This is for Great Britain as well as for Northern Ireland. However, there are differences in how they apply in Great Britain and Northern Ireland. Great Britain operates its own exemptions system, independent of the EUexemptions system. Northern Ireland continues to follow the EU exemptions system.

UK RoHS Update: Check the Latest Documentation

The ‘How to comply’ section is amended in relation to technical documentation and notifications guidance and form updated. We kindly refer to the official UK government page that published this update: Guidance for manufacturers, importers and distributors.

Other links and downloads:

• RoHS Directive explained
• WEEE Directive explained
• REACH Regulation explained

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What Is The Current Trend In The US?

According to a Boston Consulting Group poll, the United States have surpassed the European Union as the most important market for medical device makers. 89 Percent of MedTechs planning to prioritize US Food and Drug Administration (FDA) approval in the future. In one of our earlier posts, we summarized the results of this survey. 

Are the MDR’s New EU Standards a Considerable Constraint?

UK-based Healthcare Business International (HBI) thinks the economic impact could be very painful. The author of their blog, David Farbrother, states:

“There is a new threat to healthcare businesses across Europe which, HBI hears, has the potential to have a greater impact than Covid or Brexit in terms of costs.”

He continues: “The EU Medical Device Regulation is now in place after a transition period, and it strengthens the existing regulatory system for medical devices in Europe in a way that many companies find distasteful. The new standards could lead to the EU adopting a US-style FDA approach. Then more clinical data will be required before devices can be approved. It can easily be argued that this will impose additional costs.”

Is Additional Paperwork Necessary for Improved Product Safety?

This question is at the root of many fierce debates. On the one hand, there is the group that believes that additional paperwork only increases costs. But it will not increase the safety of the devices. On the other hand, others point to the PiP affair of 2010. Back then, regulatory and quality control procedures failed. Thousands of women suffered from the health risks of PIP breast implants. Either way, when the EU-MDR lurches towards the US-FDA approach, it is likely that costs will rise.

How Is Britain Taking It?

When it comes to medical devices, the UK now has its own regulation. However, it is more or less the same as the EU’s regulatory system. Critics say the options are two-way: either control can be tightened, or control can be loosened. However, the second option is not attractive to international manufacturers. They argue that producing products at two levels is more difficult than producing one standard product at a higher level.

What Is The Preliminary Conclusion?

After the transition phase, the European Union’s MDR is already in place. It tightens the existing regulatory framework for medical devices in Europe. And that in a way that is unacceptable to many market participants. They find the additional paperwork unnecessary and cost-prohibitive. With the new rules, the EU-MDR lurches towards a US-FDA approach and manufacturers, don’t like that.

Links, sources and downloads:

• The PIP scandal
• Boston Consulting Group
• Healthcare Business International

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The time of the pandemic seems, at least for the time being, to be behind us. We now see that the period behind has forever changed the way we work and live. This is also a fact for the medical device and related artificial intelligence industry. A digital transformation took place for several reasons. There is the assurance of product quality, but also the conformity to the currently applicable regulations regarding the safety of the equipment.

Artificial Intelligence’s Influence in Medical Regulations

There is a clear trend: the medical industry is struggling with the growing demand for their services. Added to this is the fact that some of the personnel involved are struggling to meet the changing needs of patients. After all, the medical device industry is improving at a rapid pace. This is due to the ever-increasing group of patients with changing motivations. All parties involved have to keep up. So do the regulations and their enforcement.

Huge expenses and operational inefficiencies are forcing companies to rethink their entire life cycle. The role that artificial intelligence will play in this is also becoming increasingly important. It is the science of equipping a machine to make human decisions and mimic human behaviour. Partly due to the impact of the pandemic, artificial intelligence has long since ceased to be science fiction and has become a daily reality. So when we take a look at the development of medical devices, then what does the future hold for compliance?

Strict Regulatory Standards can Provide Reasonable Safety

Very strict regulatory standards apply to the safety of medical devices. Artificial intelligence provides meaningful insights. For example, it can discover (small) patterns in gigantically large data sets and make advanced analyses of how different systems work. It also has predictive abilities with regard to reading texts and symbols. For humans, these are often laborious procedures that take a lot of time. Artificial intelligence allows this to be done in a fraction of the (human) time. It can also significantly improve error handling and performance management.

Digital Innovation is the Key to Conformity and Growth of the Medical Industry

The medical industry faces many operational challenges. One is that they must maintain ongoing compliance with then-current safety policies. New standards are created and the industry is facing deadlines to meet them. New technologies are going to help with that. Think artificial intelligence, 3D printing, and cloud-based services. They will not replace human interaction and intelligence, however, they will play a major role in reducing the risk of errors and increasing efficiency in various areas.

Compliance and the Growth of the Medical Industry, does it Collaborate?

We must ask this is order to continue the growth and innovation on one hand and keep the market safe on the other. There is already a noticeable shift in where the industry’s prioritized approval lies: The US-based FDA is now top-ranked, above EU authority. According to a study from the Boston Consulting Group the shift is being driven by the EU’s “complex and unpredictable” Medical Device Regulation (MDR). In our post EU No Longer Priority Market For Medical Device Manufacturers we commented on this shift.

This raises even more questions about the route to take for safe medical devices in the future without interfering with new developments…

Links & Downloads

• Boston Consulting Group
• Blogs:
  • New MDCG guidelines for MDR compliance of older devices and requirements for parallel imports into the EU
  • Artificial Intelligence, New EU Rules Proposals
  • UKCA mark for medical devices: The practicalities
  • Permanent AI-Working Group
• Source of this article: Elizabeth Engler Modic from Today’s Medical Developments

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On March 30, 2022, the European Parliament and the Council published the proposal for new harmonized standards for marketing construction products. These standards should replace Regulation (EU) 305/2011, the CPR.

At the same time, the new harmonized standards should amend Regulation (EU) 2019/1020 on market surveillance and compliance of products.

What is the CPR?

Regulation (EU) No 305/2011 (the ‘Construction Products Regulation’ or CPR) lays down harmonised conditions for the marketing of construction products. In doing so, the CPR ensures that the single market runs effectively and that construction materials are freely moved throughout the EU. It does so through harmonized technical requirements, which establish a common technical language for testing and communicating building product performance.

What Are The Reasons For This Proposal?

In their 2016 implementation report on the CPR, the Commission found some flaws in its implementation. Furthermore, it identified plenty of other issues, including standardization, micro-enterprise simplicity, market surveillance, and enforcement. All of these deserve additional investigation and discussion. The shortcomings of the framework hinder the functioning of the single market for construction products, and therefore they fail to achieve the CPR’s objectives.

Additionally, there is a need to improve the functioning of the still fragmented single market for construction items in order to realize the potential for growth and jobs. The CPR’s participation in efforts toward energy- and resource-efficient structures and renovations (as well as addressing the sustainability of construction materials), was emphasized in the European Green Deal Communication, the Circular Economy Action Plan, and the Renovation Wave Communication. 

Also, The proposal for a revised Energy Performance of Buildings Directive stressed the need of calculating the Global Warming Potential of new structures as of 2030, using life cycle GHG emissions from buildings and building materials. GHG stands for Greenhouse Gas. 

What are the main objectives of this proposal?

As a result, the CPR revision’s two main goals are:

• 1. to create a well-functioning single market for construction products and 
• 2. to contribute to the green and digital transition’s goals, especially the contemporary, resource-efficient, and competitive economy.

The proposal is part of the Regulatory Fitness Programme (REFIT). It matches with the REFIT program’s goals of making EU rules clearer, more focused, and easier to comply with. There are 4 main problems identified and this proposal aims to tackle them:

• 1. Single market for construction products is not achieved.
• 2. There are implementation challenges at a national level.
• 3. Complexity of the legal framework/simplification is not achieved.
• 4. The CPR is unable to deliver on broader policy priorities, such as the green and digital transition, and product safety.

Downloads and links:

• Official EU Proposal
• Construction Products Regulation – Regulation (EU) No 305/2011

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Who’s Initiative Is This?

OPSS has been working with consumers and businesses in recent months to assist in the development of a Code of Practice. This will help businesses understand their obligations to provide safe products to customers. The British Standards Institution (BSI), the UK’s national standards body, has been sponsored by OPSS to develop a Code of Practice. The main goal is to assist businesses in bringing goods to market safely. 

For Whom Is This Code Released?

“PAS 7050:2022, Bringing safe products to market”, was released to assist businesses in meeting their product safety duties. As a result, it should ensure that new and used consumer products placed on the market are safe. PAS stands for Publicly Available Specification.

“As product supply chains become more complex, businesses need to develop their systems to ensure they only bring safe products to market. This new Code will help protect consumers by supporting businesses to get it right the first time. The (PAS) has been developed by BSI, which has brought experts together. The expertise is in the field of consumer organizations, manufacturers, retailers’ businesses, and regulators.

Furthermore, OPSS also asked BSI to oversee a PAS 7100 examination of product recalls and corrective actions. These two Codes of Practice are now mutually beneficial. This new PAS includes modifications to encompass online marketplaces, as well as repair and refurbishing, for better product recalls”

Graham Russell, Chief Executive of the OPSS

What Is This Code For Safe Marketed Products About?

The objective of a Publicly Available Specification is to speed up standardization. This code for safe marketed products is designed to help businesses. PAS 7050:2022 is a two-part standard. It focuses on the processes, procedures, roles, and responsibilities associated with bringing safe consumer products to the market.

• Part I is intended for businesses. This includes manufacturers, designers, importers and distributors.  Furthermore repairers, refurbishers and the operators of online marketplaces for consumer products are within the scope.
• Part II is intended for regulators that support businesses in not only meeting the guidance in Part I but also the implementation of a product safety management plan (PSMP).

What Does PAS 7050:2022 Cover?

Part I of the Code For Safe Marketed Products

This part gives recommendations for the management of internal systems and supply chains. It focusses on the delivery of safe products to consumers. Besides this, it also applies to all new and second-hand consumer products (and their components, ingredients and raw materials. These include products for hire and loan. Consumer products include those intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers.

NOTE: 

Firstly part I is limited to the safety of products only. It is not concerned with safety in the workplace. Nor is it concerned with protecting the safety of persons due to the environmental impacts that can be caused by products. It doesn’t cover products covered by sector-specific schemes (e.g. automotive, medicines, medical devices). Nor does it cover transactions made consumer to consumer without the intermediation of any business.

Part II of the Code For Safe Marketed Products

This part provides recommendations for all those with regulatory responsibilities for consumer product safety, i.e. from policy through to enforcement. It covers how regulators can subsequently:

• support businesses in developing their product safety management plan (PSMP) so that they bring only safe products to the market;
• support businesses in assessing and improving the quality, documentation, and implementation of their PSMP; and
• subsequently, respond proportionately where businesses fail to meet their legal obligations.

Why Is There a Code For Safe Marketed Products And Why Should You Use It?

This PAS can help the government and industry improve how product safety is integrated into everyday operations. It can also assist organizations in the following ways:

• firstly to ensure that products comply with consumer safety product legislation;
• secondly to improve the efficiency with which safe products are brought to market;
• thirdly to accelerate innovation and expertise in safe product manufacture;
• subsequently to give supply chain partners more confidence in your products, making it easier to trade; and finally
• reduce product-safety related repetitional, commercial, and compliance risks.

PAS 7050:2022 contributes to UN Sustainable Development Goal 3 on good health and well-being and Goal 9 on industry, innovation and infrastructure. 

Sources, links and downloads:

• Office for Product Safety & Standards (OPSS) Official website
• OPSS News Story / Publication about the Code of Practice
• The British Standards Institution (BSI), release about the Guide/Code of Practise
• Safe products for consumers, PAS 7100:2022 and AS 7050:2022
• Our OPSS-related blog about the HTML-accessibility of their guidance
• PAS explained on Wikipedia

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Philips Health Systems ventilators safety hazard alert. This alert concerns V60 and V60 Plus non-invasive ventilators. The official warning from the Medicines and Healthcare products Regulatory Agency (MHRA) is published on March 29, 2022.

Philips Health Systems has found a serious safety concern related to the potential for all of their V60 and V60 Plus non-invasive ventilators to shut down unexpectedly. Invasive ventilators with the V680 model number are also affected in critical care situations.

THIS IS A NATIONAL PATIENT SAFETY ALERT FROM THE BRITISH HEALTHCARE REGULATOR

All hospital trusts and other healthcare providers who use the impacted ventilators should take action as soon as possible. This is a complex and life-threatening National Patient Safety Alert. An executive leader should be in charge of implementation, care and heads of procurement.  

Explanation of Identified Safety Issue

In March 2022, Philips Health Systems notified the MHRA of a serious safety concern over the potential for all of their V60 and V60 Plus non-invasive ventilators to shut down unexpectedly. Invasive ventilators with the V680 model number are also affected in critical care situations.

The V60 and V60 Plus are intended for usage in hospitals. They can be used to treat patients in critical care and high-dependency units (HDUs) with average volume-assured pressure support (AVAPS), pressure-controlled ventilation (PCV), continuous positive airway pressure (CPAP), and positive pressure ventilation (PPV).

The safety concern identified relates to a number of electrical faults in the devices, which can result in an unexpected shutdown, leading to loss of ventilation.This shutdown can take place in two ways: 

• The first will emit a warning tone to inform the user that the machine is about to shut down. This will alert the user that they need to change their ventilation source. While this second source of ventilation is being prepared, the patient may become unventilated.
• The device will shut down without notice in the second failure condition. The patient will be unventilated until the clinician becomes aware and responds if a ventilator fails in use and does not alarm.

Ventilation failure can have a serious health impact on patients if it goes unreported by healthcare workers. Hypoxia is one example, which might cause long-term cognitive impairment in the patient. If a patient is without ventilation for an extended period of time, there is a risk of death.

Because Philips does not have a permanent solution to this problem, the MHRA issues this alert to assist hospitals in managing the risk.

Note: This is not the same notice that the MHRA issued on September 23, 2020, for a similar set of devices. This alert should be followed up on right away.

Actions Required

All Actions to be Completed by 31 May 2022

• Urgently identify and locate affected devices in your organization.
• Identify alternative ventilators available on site. (a) If no alternatives are available, use local procurement procedures to acquire suitable alternative devices. (b) If no suitable alternative is available, and capacity is an issue currently (or expected imminently), additional devices are available for NHS organizations. Details for how to access these devices can be found in the ‘Additional information’ section of this alert.
• Train all relevant staff on alternative ventilators and ensure training records are up to date.
• If continued use of the device is required while actions 1–3 are implemented, extra patient monitoring should be enacted as detailed in the ‘Additional information’ section. A backup form of ventilation must be available at all times
• When actions 1–3 are complete, remove affected ventilators from use and quarantine.
• Place the alternative devices into service in place of the affected ventilators
• You may continue to use affected ventilators if there is a risk of severe patient harm due to lack of ventilator availability. A thorough risk assessment must be completed, and additional monitoring must be used (see action 4).

Additional Information for the Philips Health Systems Ventilators Safety Hazard Alert

Information on Adverse Incidents

Philips has received five reports of unexpected shutdowns in the UK linked to this issue since 2018. All of these occurrences were preceded by relevant alarms. To yet, no patient injury has been documented in the United Kingdom.

There have been 340 reports of similar failures all around the world. There have been a lot of major injuries as well as several fatalities as a result of this. In the United Kingdom, none of the cases involving patient death or harm have occurred.

Ordering of Replacement Devices if Required

The DHSC National COVID ICU Equipment Reserve provides free alternate ventilators to NHS organizations in the United Kingdom. A limited number of Lowenstein Medical Prisma VENT50-C devices will be made available to ease the transition away from the affected Phillips devices in cases where there is an immediate clinical necessity.

Organizations in the NHS in England can order this equipment directly via their regional EPRR leads on the NHS Foundry system.

Devolved Administrations can order equipment by emailing the DHSC Medical Technology Directorate Operations team at medtech.operations@dhsc.gov.uk.

Please contact medtech.operations@dhsc.gov.uk if you have any questions or would like to request a full list of available devices.

Devolved Administrations Additional Contact Points for Supply Issues

• Scotland – Health Boards in Scotland should contact National Procurement to discuss COVID-19 pandemic ventilator supply (if required). National Procurement contact details are: Kate Henderson, kate.henderson@nhs.scot, tel: 0781 353 1487 or Josh Foggo, josh.foggo@nhs.scot, tel: 07855 060 653.
• Wales – Please contact haz-aic@gov.wales for guidance.
• Northern Ireland – please contact niaic@health-ni.gov.uk.

Risk Assessment and Additional Patient Monitoring Requirements

Philips Health Systems ventilators safety hazard alert:

If any of the impacted devices must be used until suitable substitutes can be found, a thorough risk assessment must be conducted and recorded before the patient starts breathing.Patients who need to use these ventilators should be placed in a ward where they can be observed by healthcare professionals. If the patient is in a respiratory or acute medical ward, consider whether they should be moved to a critical care unit. At all times, a backup source of ventilation must be accessible.

When possible and appropriate, independent capnography (CO2) monitoring should be used. This monitoring should have alarm limits that are appropriate for the patient. Capnography is used to ensure that the patient is breathing and that airflow is passing through the machine. It should not be used to monitor CO2 levels in place of blood collection. Capnography monitoring should be taught to all staff who care for the patient.

At all times, the patient’s physiological status should be monitored appropriately. This comprises non-invasive blood pressure, electrocardiogram (ECG), and blood oxygen saturation levels (SpO2). All measurement alarm limits should be set appropriately for the patient. All alarms should be attended to as quickly as possible.

Stakeholder Engagement

An incident management team was consulted on the actions detailed in this alert. This team consisted of members of the Department of Health and Social Care, NHS England and NHS Improvement, and representatives from the Scottish, Welsh, and Northern Ireland Governments.

Report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

For any enquiries about this alert contact: info@mhra.gov.uk

Sources, links, and downloads for additional information:

• National Patient Safety Alert: Philips Health Systems V60, V60 Plus and V680 ventilators: potential unexpected shutdown leading to complete loss of ventilation (NatPSA/2022/002/MHRA)
• Medicines and Healthcare products Regulatory Agency

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What Is RoHS?

RoHS is an EU directive that restricts the use of certain hazardous substances in electrical and electronic equipment (such as lead, mercury, cadmium, hexavalent chromium, PBBs, and PBDEs). The scope of RoHS has expanded steadily since its initial introduction. It was extended in July 2019 to include all EEE that is not specifically exempted. In December 2021, the Commission passed 12 Delegated Acts ending existing exclusions for specific product categories.

Why Does RoHS Need Revision?

RoHS is being amended as part of a much bigger review of EU chemicals law and a general effort to make products more environmentally friendly. Other significant components of EU chemicals law, such as REACH and the CLP, are also being amended at the same time.

What Are The Changes That We Can Expect?

The Commission is currently looking at the following legislative proposals:

• The introduction of non-legislative “soft-measures” ; 

(e.g. an update to the RoHS FAQ document to describe how RoHS interacts with other laws (primarily REACH and Ecodesign).

• The introduction of revising legislative “hard measures” ;

(these are to either clarify or to improve: 

• the exemption criteria and process, 
• the substance restrictions trigger, criteria and process, and/or 
• the implementation and enforcement.)
• Transforming the RoHS Directive into a Regulation 

(to simplify its application, this should apply in the same way in all countries)

• Repealing the RoHS Directive

(RoHS’ provisions should be incorporated into REACH and/or sustainable products legislation, such as the new EU ecodesign rules).

What Is The Goal Of This RoHS Revision?

In the European Commission’s 2022 work programme, the goal of the RoHS revision is stated as to: 

“Strengthen and simplify legislation to better protect citizens and the environment against hazardous chemicals, inter alia by taking into account the move towards a process of ‘one substance – one assessment’ and providing for greater transparency when prioritising action to deal with chemicals, as well as by encouraging innovation for the development of safe and sustainable alternatives, as highlighted in the European Green Deal. The revision will aim to reduce administrative burden with regard to the exemptions process.”

Hopefully, the RoHS revision will help make requirements for consumer electronics clearer and provide greater alignment with the rest of the EU chemicals regime. The public consultation is your chance to share your thoughts on the best way to improve the RoHS Directive. Here you may find further information as well as a link to the consultation questionnaire.

The Commission has suggested that it will publish draft legislation in Q4 of 2022.

The expectation is that this legislation would likely be passed in 2023/2024 and the enforcement date would be 2025/2026.

How Can The RoHS Revision Impact Your Business?

Changes could have far-reaching implications, especially if they lead to tighter controls on the chemicals which can be used in electronic items sold in the EU. Changes to RoHS are expected to have an impact on legislation in other nations throughout the world.

Once it is clear how the Commission intends to alter the RoHS regulation, we will be able to analyze the impact of any modifications.

How Does This Impact Your Business In The UK?

For the time being, the UK RoHS Regulations are still in line with EU policy. It’s unclear whether the UK will take the same strategy as the EU in the future, or if the EU’s measures will be repeated in the UK. The UK government is likewise concerned about hazardous compounds in products. Reduced usage of hazardous compounds in materials and products could increase the use of secondary materials, according to a current waste prevention consultation (as they are more likely to comply with the potentially more stringent future restrictions on the use of hazardous substances). 

The consultation document “Waste Prevention Programme for England” and the policy paper “Our waste, our resources: a strategy for the future” can both be found in the link & download section underneath.

Links and downloads:

• The current RoHS explained on cemarking.net
• The RoHS in the Official Journal of the EU
• The European Commission’s 2022 work programme
• The REACH regulation explained on cemarking.net
• More information about this consultation on the EC website
• Link to the Official Questionnaire
• “Waste Prevention Programme for England”
• “Our waste, our resources: a strategy for the future”

Source: Emma Bichet and Corinne Robinson from Cooley.com

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Why Do They Start This Campaign?

The campaign focuses in particular on raising awareness among consumers when purchasing smart devices, modems and routers. The Agency says there is a risk in purchasing these devices from outside the European Union, as smart devices without CE marking can cause malfunctions or even be vulnerable to hackers. The marking indicates that equipment meets European requirements for safe use within a home network. 

What Exactly Is The Problem?

In the campaign, the Netherlands Radiocommunications Agency explains what consumers should pay attention to when buying smart devices, modems and routers. The agency explains that devices without CE marking can operate in the same frequency range. Some examples of wireless products that are quite common on the EU single Market and often bear no CE marking, are:

• baby monitors, 
• dimmers, 
• remote controls, 
• weather stations, and 
• wireless headphones 

Equipment that does not meet European requirements for interference sensitivity can interfere with the safety of other devices. This is not only irritating for users, says the Agency, but can also be harmful. In the campaign, the Radiocommunications Agency therefore warns for the proper protection of smart devices.

How Can You Install a Wireless Device In a Secure Way?

The Telecom Agency’s campaign includes tips on how to install devices properly, ensure that devices are properly secured and ensure a good Wi-Fi distribution in a home. It has also put a page online for distinguishing between a real and a fake CE mark. In the “Links and Downloads“-section underneath you will find more information about this particular subject, including a tutorial video on false and real CE certification.

What Is The Difference Between a Real And a False CE Mark?

For people with a technical background, the information page may be full of open doors, but the campaign is therefore aimed at the average citizen who gets devices cheaply from abroad without being aware of the potential dangers. Over the next two weeks, posters will be hung in public spaces in the six major cities of Groningen, Amsterdam, Rotterdam, Utrecht, Eindhoven and The Hague, and an online campaign will be set up.Since February, the Netherlands “Agentschap Telecom” (AT), which is the Dutch Radiocommunications Agency has been investigating smart home devices together with the ACM, “Autoriteit Consument en Markt” (the Dutch equivalent of the US FDA e.g.). 

What Is The Goal Of This Campaign And Investigation?

Regulators look at whether these devices are secure enough, receive updates and whether they ‘continue to do what was agreed‘ after purchase. The ACM and the AT want to use the investigation to monitor the rules regarding home automation devices. 

Links and Downloads:

• Official Campaign-page from the AT (Agentschap Telecom)
• Official website from the Dutch “Autoriteit Consument & Markt” (ACM)
• How to determine whether a CE Marking is True or False? Very educational video.
• What is the CE Mark? Tutorial video
• Product Safety Alert Website and also on Instagram.
• Updates & Latest CE Marking News

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The European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (CENELEC) are requested to draft one or more new European harmonized standards or revise existing standards in support of (EU) 2019/2013 and (EU) 2019/2021 for electronic displays.

CEN and CENELEC shall prepare a joint work program indicating all the standards listed in Annex I, the responsible technical bodies and a timetable for the execution of the requested standardisation activities.

Deadline for feedback: 14-04-2022 
Commission contact point for this notification ENER-ECODESIGN@ec.europa.eu

ANNEX I

– NEW STANDARDS TO BE DRAFTED, 

– EXISTING STANDARDS TO BE REVISED, AND 

– DRAFT STANDARDS TO BE COMPLETED, 

REFERRED TO IN ARTICLE 1 SUITABLE FOR PUBLICATION IN THE OFFICIAL JOURNAL OF THE EU

Reference information and adoption deadlines:

The list underneath is given as an overview of the requirements to be covered it is up to the ESOs (European Standardization Organisations) to decide whether one or multiple standard(s) are needed.

The dated references given here may be replaced by more recent ones, at the time of publication of the deliverables under this SReq.

‘Adoption' refers to the relevant European standardization organization making an adopted standard available to its members or the public.

1. The European standard on measurement of power demand in Watts (W) in on mode in standard dynamic range (SDR) for electronic displays. Reference standard(s) EN 62087-1:2016, EN 62087- 3:2016, EN IEC 62087-7:2019 or any other relevant standard. Date of deadline will be 27 months after notification of this Decision to the ESOs.

2. The European standard on measurement of power demand in Watts (W) in on mode for displays with High Dynamic Range (HDR) functionality activated. Reference standard(s) IEC TR 63274:2021, updates of IEC 62087-2:2016 and IEC 62087-3:2016 or any other relevant standard (4). The date of deadline will be 27 months after notification of this Decision to the ESOs. Next editions of IEC 62087-2 and IEC 62087-3 (currently under development) will cover HDR.

3. The European standard on testing method for ABC (Automatic Brightness Control) including control characteristics for electronic displays. Reference standard(s) EN 62087-1:2016, EN 62087- 3:2016, EN IEC 62087-7:2019 or any other relevant standard. The date of deadline will be 27 months after notification of this Decision to the ESOs.

4. European standard on testing method for forced menu and set up menus for electronic displays

Reference standard(s) EN 62087-1:2016, EN 62087- 3:2016, EN IEC 62087-7:2019 or any other relevant standard. The date of deadline will be 27 months after notification of this Decision to the ESOs.

5. European standard on measurement of peak white luminance for electronic displays with Standard Dynamic Range (SDR) functionality activated Reference standard(s) EN 62087-1:2016, EN 62087- 3:2016, EN IEC 62087-7:2019 or any other relevant standard. 01.01.2024/ Date will be 27 months after notification of this Decision to the ESOs.

6. The European standard on measurement of power demand in Watts (W) in off mode, standby and networked standby mode for electronic displays Reference standard(s) EN 50564:2011, EN 50643:2018, EN 62087-1:2016, EN 62087-3:2016, EN 62087-7:2019 or any other relevant standard. Date will be 27 months after notification of this Decision to the ESOs.

7. The European standard on method for determining the availability of off, standby and networked standby modes for electronic displays. Reference standard(s) EN 50564:2011, EN 50643:2018, EN 62087-1:2016, EN 62087-3:2016, EN 62087-7:2019 or any other relevant standard. Date will be 27 months after notification of this Decision to the ESOs.

8. European standard on method for determining the availability of automatic standby in electronic displays. Reference standard(s) EN 50564:2011, EN 50643:2018, EN 62087-1:2016, EN 62087-3:2016, EN 62087-7:2019 or any other relevant standard.  Date will be 27 months after notification of this Decision to the ESOs.

9. The European standard on methods for the measurement of screen area and verification of resolution for electronic displays. Reference standard(s) EN 62087-1:2016, EN 62087- 3:2016, EN 62087-7:2019 or any other relevant standard. Date will be 27 months after notification of this Decision to the ESOs.

10. The European standard on testing and assessment methods for material efficiency for electronic displays. Reference standard(s) EN 45554:2020, EN 45555:2019, EN 45556:2019, EN 45558:2019, EN 1043-1/A1:2016 or any other relevant standard. Date will be 27 months after notification of this Decision to the ESOs.

11. The European standard on methods for determining an industrial display including ingress protection level for dust tightness and projected water. Reference standard(s) EN 60529:2001/A2:2014. Date will be 27 months after notification of this Decision to the ESOs.

12. The European standard on method for determining the specifications of a professional display. Reference standard(s) EN 62087-1:2016, EN 62087- ESOs 3:2016, EN 62087-7:2019 or any other relevant standard. Date will be 27 months after notification of this Decision to the ESOs.

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MedTech Manufacturer’s Executives Respond to BCG’s Poll

Boston Consulting Group (BCG), which worked with UCLA Biodesign to present data from a survey of 104 senior executives, said the shift is being driven by the EU’s “complex and unpredictable” Medical Device Regulation (MDR). The MDR took effect in mid-2021, making obtaining a CE mark more difficult.

The EU’s MDR “is killing innovation,” stated the European cardiac device business CEO who responded to the study.

The Appeal Of The European Market Is Now Declining

The decline in the EU’s appeal has occurred at a time when the FDA is courting the MedTech industry. Only 34% of respondents say the EU has adapted adequately to the changes brought on by digital technology, while two-thirds of respondents believe the FDA has. According to BCG’s study based on survey data, the FDA has “spent extensively to keep pace with digital changes” and the United States “has emerged as the go-to-market for worldwide launch.”

European Approach vs United States Approach

There is a significant difference in the approach that regulators on both sides of the Atlantic seem to be using nowadays. This is leading to a shift in the industries’ priorities.

Europe Is Redefining Requirements

Regulators on both continents have shifted their stance on MedTech in recent years. The most significant developments have occurred in the European Union, where the MDR and the In Vitro Diagnostic Regulation are redefining what it takes to bring pharmaceuticals to market in the region.

At the same time, the FDA has set a goal of making the United States a priority market for device developers.

The FDA Is On Track To Make The US The Priority Market

According to the FDA’s most recent evaluation, this leads to the current situation that nearly two-thirds of manufacturers of novel technological devices expect to introduce their goods to the United States first. Either just in the US or in tandem with other key markets. The BCG research adds to the growing body of evidence suggesting the FDA is on track to meet its goal.

The EU Now Has Fallen Behind Japan And China

The shift in focus from Europe to the United States appears to be due to what Europe has done to alienate the business as much as what the FDA has done to woo it. The EU has now fallen behind Japan and China on the list of priority markets for 23% of CE-marked companies, suggesting concerns about the impact of MDR and other considerations.

Europe Alienates MedTech Businesses, US Adapts To MedTech Businesses

“Respondents overwhelmingly view new MDR rules as complex and unpredictable, making it less appealing to develop and launch novel products in Europe. Other factors, including Brexit and intense reimbursement pricing pressure, may also reduce the attractiveness of pursuing the CE mark,” the BCG report states.

Only 22% of those polled believed the EU regulatory confirmation process for conventional medical devices is predictable. The United States’ percentage was 62 percent. Although the FDA still has space to improve, with just 33% of respondents believing its digital product pathway is predictable, there was widespread approval for some of its important objectives and a belief that it currently offers a clearer path to market than the EU.

According to the study, 79 percent of respondents strongly agreed or somewhat agreed that the FDA is effectively responding to medical improved technology. When it comes to artificial intelligence and machine learning, executives polled believe US regulators have a significant advantage.

AI/ML Products Require a High Level Of Competence From Reviewers

According to the BCG report, MedTech companies are rapidly developing AI/ML products (Artificial Intelligence / Machine Learning)

“More than half of the FDA’s 343 approvals of these kinds of products since 1997 were in 2019 and 2020. Because they are creative, these items require a higher level of competence from reviewers as well as more regulatory clarity for businesses“, according to the report. 

The FDA’s breakthrough device designation program was praised by survey respondents, with 88 percent saying the guideline is at least somewhat clear and 75 percent believing it will lead to quicker patient access. More than half of those polled felt the program encourages more flexible research design.

Information of interest:

• Summary of the survey, from Boston Consulting Group: For Cutting-Edge Innovations, the US Pulls Ahead of the EU in Medtech Regulation
• Official website of the FDA
• Text MDR
• EU MDR explained

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Great Brittain And Northern Ireland Guides Made Easier Accessible

The OPSS Legal Guidance has been enhanced from PDF to HTML format on 15 March 2022. The UK Office for Product Safety and Standards attempts to make them more accessible for users but their content remained the same. It concerns all guides that are mentioned underneath.

These guides will help you understand the legislation as they were revised at the end of the transition period on December 31, 2020, including producer and distributor duties.

To access these regulatory guides even more conveniently, we lined them up for you. Underneath are the links to the different guides in HTML formats, for GB as well as for NI.

Overview Of GB And NI Guides On Product Safety Legislation:

General Product Safety Regulations 2005 GB / NI

All consumer products must be safe in their customary or probable use, according to the standards. Specific laws exist for certain product categories, setting out essential requirements for product safety.

Toys (Safety) Regulations 2011 GB / NI

Supply of Machinery (Safety) Regulations 2008 GB / NI

This guidance will assist your understanding of the regulations as amended at the end of the transition period on 31 December 2020 and includes obligations for responsible persons (manufacturers and their authorized representatives).

The legislation applies to:

• machinery
• interchangeable equipment
• safety components
• lifting accessories
• chains, ropes, and webbing
• removable mechanical transmission devices
• partly completed machinery

Radio Equipment Regulations 2017 GB /  NI

The Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 were repealed on December 26, 2017, however, they still apply to devices that were put on the market before that date.

Electrical Equipment (Safety) Regulations 2016 GB / NI

The Electrical Equipment (Safety) Regulations 1994 were revoked on 8 December 2016 but continue to apply to relevant products placed on the market prior to this date.

Electromagnetic Compatibility Regulations 2016 GB / NI

The Electromagnetic Compatibility Regulations of 2006 were repealed on December 8, 2016, however, they still apply to products that were placed on the market or put into operation before that date.

Personal Protective Equipment (Enforcement) Regulations 2018 GB / NI

The PPE Regulations 2002 were revoked on 21 April 2018 but continue to apply to relevant products placed on the market before 21 April 2019.

Equipment for Explosive Atmospheres Regulations 2016 (Applies to England, Scotland, and Wales)

The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 1996 were revoked on 8 December 2016 but continue to apply to relevant products placed on the market or put into service prior to this date.

Gas Appliances (Enforcement) Regulations 2018  GB /  NI

Guidance for businesses on Regulation 2016/426 and the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018. The Gas Appliances (Safety) Regulations 1995 were revoked on 21 April 2018 but continue to apply to relevant appliances and fittings placed on the market before this date.

Lifts Regulations 2016 GB / NI

The Lifts Regulations 1997 were revoked on 8 December 2016 but continue to apply to relevant products placed on the market prior to this date.

Pressure Equipment Safety Regulations 2016 GB / NI

The Pressure Equipment (Safety) Regulations of 1999 were repealed on December 8, 2016, however, they continue to apply to products released prior to that date.

Pyrotechnic Articles (Safety) Regulations 2015 GB / NI

The Pyrotechnic Articles (Safety) Regulations 2010 were revoked on 17 August 2015 but continue to apply to relevant products placed on the market before this date and to pyrotechnical articles to which regulation 74(1) or (2) applies.

Simple Pressure Vessels (Safety) Regulations 2016 GB / NI

The Simple Pressure Vessels (Safety) Regulations 1991 were revoked on 8 December 2016 but continue to apply to relevant products placed on the market prior to this date.

UKCA vs CE MARK, PRODUCT SAFETY AND COMPLIANCE (OPSS) UPDATE PUBLISHED FEBRUARY 2022

After the Brexit, a transition period for product safety and standards, as well as market surveillance, remained in effect. During this period, EU rules continued to apply throughout the UK. This period ended on December 31, 2020 (even though the UK government approved to extend the transition period for CE product marking in the UK until January 1, 2023). The legislation covers industrial products marketed in GB that were previously subject to EU CE marking.

In our post in February 2022, we summarized the latest updates on product safety for your convenience.

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Philips openly acknowledged product safety risks with certain sleep apnea and ventilator machines. On June 24, 2021, the Dutch company initiated a voluntary recall notification.

“Philips’ Attempts To Alert Users Are Inadequate”

However, the  U.S. Food and Drug Administration (FDA) is aware of frustration expressed by patients, users, and durable medical equipment suppliers. Some are unaware of the recall and have received insufficient information on their next steps regarding the recall process. Now, the FDA has taken action, but this problem concerns consumers worldwide.

“Philips’ previous attempts to alert customers about a sleep device recall are inadequate”, according to the FDA. A news release from March 10, 2022 announced that a notification order to Philips Respironics has been issued. The company is ordered to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about the recall and the health risks posed by the foam used in the recalled products.

The order also directs Philips “to maintain prominently displayed information”  to patients regarding the risk of using ozone cleaners on the recalled devices on their main web page for the recall and provide instructions for device users to register their devices on the Philips website. 

In November 2021 we published the article: Philips is liable for health problems’ say users of apnea devices. Four Dutch users of a Philips device used to treat sleep apnea, the Dreamstation 1, are holding the manufacturer liable for health problems. Their lawyer Mr. Mark de Hek has announced this in a letter to the company. The users say they suffer from headaches or breathing problems or have cancer. 

“Philips Does Not Provide Patients And Other Consumers With Adequate Information”

The order comes nine months after Philips issued a Class I recall for some sleep apnea and ventilator units. Despite its efforts to have Philips “voluntarily enhance” communication efforts, the FDA continues to hear from patients who are uninformed of the recall. In addition to concerns over the recall’s notice, the FDA states that it has worriment that Philips does not provide patients and other consumers with adequate information on the recall’s status and the process for receiving replacement devices. 

Philips issued the official recall due to the breaking down of foam used to dampen sound in machines. That provides a risk of particles being breathed or consumed by users, potentially exposing them to harmful substances. More than 5 million devices were recalled as a result of the recall.

“Once broken down, the foam can result in serious injury, including injuries that can be life-threatening, can cause permanent impairment and/or require medical intervention to prevent permanent injury”, according to the FDA in Thursday’s statement.

FDA Order

The FDA ordered Philips to alert all device users, durable medical equipment suppliers, distributors, retailers, and healthcare providers who prescribe the recalled items about the health hazards posed by the foam. Other orders from the FDA are to improve the information on Philips’ website and that the company must provide a link to testing done on devices using the foam.

Philips has 45 days from the time of the order to comply. We will keep you up to date on the latest developments. 

Sources:

• Philips
• FDA News Release
• Medtechdive

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After the Brexit, a transition period remained in effect. During this period, EU rules continued to apply throughout the UK. This period ended on December 31, 2020 (even though the UK government approved to extend the transition period for CE product marking in the UK until January 1, 2023). The regulations cover industrial products marketed in GB that were previously subject to EU CE marking.

Product Safety and Compliance Regulatory Framework: UK-EU Transitional Arrangements in 2021 and 2022

The UK Government Office for Product Safety and Standards (OPSS) published an update on 23 February 2022 on some of the forthcoming changes with respect to the time before the Brexit. Underneath, we describe a summary of them.

This update includes the term Conformity Assessment Body (CAB). It is used for:

• APPROVED BODIES,
• NOTIFIED BODIES IN THE UK (FOR NORTHERN IRELAND MARKET),
• APPROVED THIRD PARTY ORGANISATIONS (RTDS),
• USER INSPECTION BODIES (UIS), AND
• TECHNICAL ASSESSMENT BODIES (TBIS).

Change in Status of CABs in the UK Previously Notified Under EU Regulations

CABs based in the UK that have been approved and notified to the EU as of December 31, 2020, will retain the status of approved inspection bodies by the UK government. EU-recognized Third Parties, User Inspection Bodies and Technical Assessment Bodies based in the UK are also recognized in the UK.

All UK-based bodies retain their status as a CAB for certifying goods placed on the Northern Ireland market. These goods will then bear the UK(NI) mark in addition to the relevant EU conformity mark.

UK-based bodies will retain the same 4-digit identification number as before.

The UK Market Conformity Assessment Bodies (UKMCAB) database was launched at GOV.UK. This database is the UK database of CABs and the UK equivalent of the EU NANDO database.

Result of UK-EU trade Agreement Regarding UKCA vs CE Mark

The UK and EU have reached an agreement on technical trade barriers. This agreement should help to ensure that there are no discriminatory regulatory regimes. It also aims to eliminate unnecessary trade barriers for UK exporters.

This is called the "Technical Barriers to Trade" (TBT).  The technical requirements for the UK and EU markets should not slow down the market.

Mutual Recognition Agreement

No commitment has been made, regarding the proposal to reach a mutual recognition agreement. As a result, CABs are no longer recognized in the UK as competent bodies to carry out conformity assessments based on EU regulatory requirements. This includes, for example, affixing a CE mark on products placed on the EU market.

Similarly, EU-based CABs are not recognized as competent to perform compliance assessments against GB regulations for UKCA marking.

In most cases, the CE mark will remain recognized until Jan. 1, 2023. This is for goods placed on the GB market (including where the assessment has been carried out by an EU CAB). After this date, the goods will have to comply with UK requirements. From then on, any mandatory third-party compliance assessments must have been carried out by a UK-based CAB. Where the third party is based outside the UK, it will have to be a body recognized under the PRA.

These measures have been introduced to give companies time to prepare for the introduction of the new regulations. However, we will continue to urge manufacturers to prepare to UKCA mark their products as soon as possible, if necessary by engaging a UK CAB.

Validity of Existing Certificates

This is about the validity of existing certificates issued by UK authorities before the end of the transition period. As stipulated in UK legislation, these remain valid for the marketing of UKCA marked products in GB. If the certificate is no longer the responsibility of the UK-based body, it will not apply. This may be, for example, because it has been transferred to a body outside the UK, such as an EU-based Notified Body.

A certificate that has been transferred in such a way will no longer be valid in the UK after the expiry of the current transition period.

Issuance of New Certificates Based on Previous Assessments

The Brexit provisions aim to facilitate the issuance of new certificates. At the request of a manufacturer, a CAB must share information on conformity assessments carried out before the end of the transition period with a body based in the other market (UK or EU).

Separate CABs in the UK issue certificates. It is also their responsibility to ensure that the products for which these certificates are issued comply with the relevant requirements. However, it is not necessarily necessary to retest or completely reassess a product before a UK body issues a new certificate.

Reviewing existing documentation by an EU-based CAB performed conformity assessment results to verify them may be sufficient. After all, the UK and EU essential requirements are currently the same.

It is not a condition of accreditation for UK CABs that they have directly performed all the assessments underlying the certificates for which they are responsible. Nor is it a condition that they conduct a full reassessment for clients they have taken on after the end of the transition period and who previously held a certification from an EU-recognized body.

It is not a condition of accreditation for UK CABs that they have directly carried out all the assessments underlying the certificates for which they are responsible. Nor is it a condition that they conduct a full reassessment for clients they have taken on after the end of the transition period and who previously held certification from an EU-recognized body. However, the CAB must ensure that the relevant requirements have been met, as it is ultimately responsible for the certification.

The receiving CAB must have a copy of the technical file. To effect a UKCA transition, the CAB must ensure that the technical file contains sufficient detail to demonstrate that the product is compliant. The UK CAB is not required to re-certify or issue the supporting certificates.

The receiving CAB must have a copy of the technical dossier which must contain evidence that the product complies with the essential requirements of the relevant regulations (including copies of all relevant supporting certificates). To effect a UKCA transition, the CAB must ensure that the technical file contains sufficient detail to demonstrate that the product complies with the regulations. The UK CAB is not required to re-certify or issue the supporting certificates.

Combining EU and UK Certification

During the period of time-limited recognition of certification by EU CABs only (limited to goods being placed on the GB market in 2021 and 2022 for most areas), it is permissible for goods to be UKCA marked and placed on the GB market based on:

• a Module B / “type-examination” certificate issued by an EU body where there is a second module (e.g. Module D) which has been carried out by a UK CAB
• a certificate issued by a UK CAB that relies in part on a separate certification (e.g. of an individual component) issued by an EU CAB.

A certificate issued by the UK may stipulate that it is valid only when the product in question is used together with another product certified by a CAB recognized by the UK. If so, it is considered valid for use together with any product certified by one of the EU that was placed on the market before the end of the period of time-limited recognition of EU certification in GB.

From 2023 (in most cases), all certificates used for products marketed in GB, including module B certificates/type-examination as well as certification, and all other certificates for which legislation requires them to be issued by an approved CAB, must have been issued by the UK approved CABs. This does not apply to CABs from the EU.

Status of EU Based Bodies and Expansion to the Scope of Accreditation

To be eligible for appointment as a CAB for the GB market for the relevant regulations, an applicant must be a legal entity in the United Kingdom (or a country with which the UK has agreed on an MRA). After the transition period, CABs not based in the UK will no longer be able to certify goods for the GB market. This provides opportunities for UK CABs to expand their scope.

UKAS remains the UK's sole national accreditation body and retains its role in the accreditation of CABs. If, as a UK-based CAB, you require an addition or modification to your accreditation scheme, you must apply for an extension of scope. Before applying, you should contact UKAS to discuss your requirements and timelines.

Annex 1 – terms used in this document

CONFORMITY ASSESSMENT BODY (CAB):

An Approved Body, Notified Body, Recognised Third Party Organisation, User Inspectorate, or Technical Assessment Body formally recognized as able to assess conformity against a particular set of regulations. In this document, CAB does not generally refer to conformity assessment bodies undertaking activities not required by legislation.

UK CAB / UK-RECOGNISED CAB:

A compliance assessment body recognized by the UK as able to carry out conformity assessment activities for the GB market. Such bodies may be located outside of the UK e.g. if they are operating under a Mutual Recognition Agreement between the UK and another country.

UK-BASED CAB:

A compliance assessment that is physically established in the UK (i.e. the legal entity which is recognized as a CAB by the UK is located in the UK even if some facilities are located elsewhere). EU CAB: A compliance assessment body recognized by the EU as able to carry out conformity assessment activities for the EU market. Such bodies may be located outside of the EU e.g. if they are operating under a Mutual Recognition Agreement between the EU and another country.

Annex 2 – List of legislation covered by OPSS update 16-02-2022

UKCA vs CE MARK, PRODUCT SAFETY AND COMPLIANCE (OPSS) UPDATE PUBLISHED FEBRUARY 2022, Source: OPSS

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From 1 January 2022, goods entering the UK from the EU or elsewhere will need a full customs declaration. Importers and traders will no longer benefit from the possibility to delay this declaration. The opportunity to stall documentation at the border for 175 days is no longer available.

Further Disruption Due to New Rules Are Expected

Having said this, the Benefits of Brexit will be used to the fullest extend. That is the thrust of Boris Johnson's message to British consumers. He made a vow in December 2021 to maximize the benefits for the UK. The same consumers however are advised to expect further disruption as new laws are set to take effect. According to the Prime Minister, the UK Government will "go further and faster” to take advantage of the “enormous potential that our new freedoms bring” in the new year.

As for the new rules: the British Frozen Food Federation (BFFF) already said that new border controls will cause serious delays at ports in 2022. Food import in the UK is 5 times the amount as their export. This means that especially in January the risk of major issues in the food supply chain is serious. Also, two mobile phone networks, EE and Vodafone, will reintroduce roaming charges for their clients traveling to Europe, starting from January immediately. Three will follow this step in May 2022.

"Restore Common Sense to UK Rulebooks"

Nonetheless, Prime Minister Johnson stated that his administration will “cut back on EU red tape” and restore “common sense to our rulebooks” in 2022. He heralds the departure from the EU. It allows Britain to forge its own policies on immigration, coronavirus vaccines, bilateral trade deals and standards. At the moment, officials are analyzing retained EU law: thousands of Brussels made regulations which have automatically been kept on the statute book after Brexit. Laws that do not stand up to criteria that benefit the UK will be reformed or even repealed.

Great Britain Is Set to Take the Lead Regarding Regulations of Innovative Products

The UK is also looking to take the lead on regulations regarding artificial intelligence and self-driving cars. further, Great Britain is set to reform data rights to be “more proportionate and less burdensome than the EU’s GDPR” regime, and reform medical devices regulation to allow for the introduction of “cutting edge technology” in the health sector.

The Prime Minister said: “A year ago today we entered our new relationship with the EU through the world’s biggest ever zero-tariff, zero-quota free trade deal – the UK-EU Trade and Cooperation Agreement. That was just the start: our mission since has been to maximize the benefits of Brexit so that we can thrive as a modern, dynamic and independent country.

“We’ve replaced free movement with a points-based immigration system. We’ve secured the fastest vaccine rollout anywhere in Europe last year by avoiding sluggish EU processes. And from Singapore to Switzerland, we’ve negotiated ambitious free trade deals to boost jobs and investment here at home."

“But that’s not all. From simplifying the EU’s mind-bogglingly complex beer and wine duties to proudly restoring the crown stamp onto the side of pint glasses, we’re cutting back on EU red tape and bureaucracy and restoring common sense to our rulebook.

“The job isn’t finished and we must keep up the momentum. In the year ahead my Government will go further and faster to deliver on the promise of Brexit and take advantage of the enormous potential that our new freedoms bring.”

Conclusion

It is clear that this government intends to make rapid progress in the process towards full independence from the EU. The self-proclaimed successes that have already been achieved are eagerly used to pat themselves on the back. However, the near future will show whether this is how it feels not only to the British consumer but also to traders and importers.

Boris Johnson Set To Maximize Brexit Benefits – source: Carl Bennet, GBNEWS

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What happened?

September 2018, a Stint, an electric boxcar used by many childcare providers to transport children, runs onto the tracks near a train station in the Dutch town of Oss. A train rams the cart. Four children between 4 and 8 do not survive the accident.

Shortly after the accident, Minister Cora van Nieuwenhuizen (Infrastructure) decides to take all Stints off the road. This decision comes as a total surprise to the childcare sector. After all, the vehicle is approved for public roads. Emmeline Bijlsma, director of the Childcare Sector Organization: "Let's be honest: accidents with cars and buses happen every day. Even fatal accidents. And yet those vehicles are not immediately taken off the road."

Decision Challenged

Daycare centers and the manufacturer challenge the minister's decision. In the end, it turns out that the ministry had made mistakes much earlier, in 2011. The ministry should not have allowed the Stint on the public roads at the time. The Ministry was so keen to have innovative vehicles on the streets that it was too lenient with the safety criteria.

The Stint had to be re-inspected, according to new criteria. Production was halted for a year and a half and the manufacturer almost went bankrupt. Childcare organizations suffer considerable damage because of the decision to take all Stints off the road. They have to arrange other transportation for a long time, such as vans and cabs.

District Court Ruling

In March 2021, the District Court ruled that the government could have known at the time of admission that the Stint did not comply with the rules. And so it is a matter of carelessness. Therefore, the manufacturer and the daycare centres are entitled to compensation, according to the District Court.

But the minister appeals the decision. The case then ends up at the Council of State. There, the state advocate argued that the government was right to remove the Stint from the road because "the level of safety was inadequate for passenger transport". According to the state advocate, the Stint that crashed was of a different type than the approved model.

Final Ruling by The Council of State: Dutch Ministry Must Compensate

The final ruling came on Wednesday 22 December 2021. For the manufacturer and the childcare centers, this brings an end to the legal battle: they are entitled to compensation from the Ministry of Infrastructure and Water Management for the ministry's decision to remove the vehicle from the road. This was decided by the Council of State in the appeal lodged by the Ministry.

As far as the daycare centers are concerned, the right to compensation applies to users of the "light" Stints with an electric motor of 800 watts, writes the council in the ruling. The Minister cannot be obliged to compensate users of 'heavier' Stints. These have officially never been allowed on the road, but have been driving for years because these daycare centres did not know that only the light Stint was allowed. Therefore, the council is calling on the minister to consult with the users of the heavier Stints about compensation.

For the 170 daycare centers alone, the damage amounts to 100,000 euros per institution, said Emmeline Bijlsma of Brancheorganisatie Kinderopvang on Monday in Nieuwsuur, a Dutch news program. The manufacturer is as good as bankrupt.

The Minister was instructed to issue a new decision, which included compensation for the manufacturer and the nurseries.

Dutch Ministry Must Compensate For Taking Stint Off The Road – sources:

• Nu.nl
• NOS.nl

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The European Union General Court dismisses Dyson’s claim for compensation for alleged loss. Dyson Ltd and other applicants seek compensation. That is for the loss which they claim to have suffered as a result of the unlawfulness of the regulation. The alleged loss is valued at € 150m or even more.

What was at the root of this conflict?

All vacuum cleaners marketed in the EU were ranked from A to G in terms of energy efficiency. The Court's case was about these energy efficiency badges. The first tests needed an empty bag or dust compartment. Dyson argued that this version did not reflect real-world use. Dyson contended with succes: The regulation was overturned in 2018 by intervention from the European Court of Justice. The 2013 Regulation was annulled. That was on the ground that the testing method carried out with an empty receptacle did not reflect conditions as close as possible to actual conditions of use. Based on this result, Dyson went back to court and claimed compensation for alleged losses.

However, on Wednesday 8 December 2021 the General Court rejected this claim. The EU's lower General Court ruled that the Commission did not violate their duty to act fairly or indiscriminately towards bagless vacuum cleaner manufacturers like Dyson. According to the General Court the Commission's choice to use an empty bag can be justified because there was enough doubt over the efficacy of tests. Therefore the EU General Court ruled that Dyson is not entitled to £150m in damages over flawed energy efficiency regulation.

“By using the standardised empty receptacle testing method, the commission did not manifestly and gravely disregard the limits on its discretion or commit a sufficiently serious breach of the principles of equal treatment and sound administration,” the court said in a summary of the judgment published on Wednesday.

The latest developments

Dyson has said it will appeal against this ruling. Sir James Dyson, the company’s billionaire owner, argued that mandatory EU tests had “illegally misled millions of consumers” and sought compensation from the European Commission for lost sales and wasted time. He basically said that testing his vacuum cleaners with empty dust compartments was an awry approach in favour of their German rivals.

According to a Dyson spokesperson: “The general court has chosen to turn back from the earlier decision of the European court of justice and seems unconcerned that the commission broke their own law and ignored Dyson’s evidence – they declare it is not obvious enough for them to justify damages. This is an insult to the millions of shoppers who were misled and totally ignores the substantial harm – running to £150m – caused to Dyson. Meanwhile the commission walks away scot-free despite having favoured the European bagged-machine lobby, including the major German manufacturers, throughout."

Dyson has the right to appeal to the court of justice within the next two months and 10 days. We will keep you up to date on the latest developments.

Dyson’s claim dismissed by EU General Court, sources:

• Press Release General Court of the European Union
• Publication of Reuters

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The UK government wants to extend the deadline for registrations in the new REACH database. The plan is to extend until October 2025. This is a two-year delay. This gives industry extra time to implement a new safety regime for chemicals. The British industry pertinently opposed to the current plans to set up a new UK chemical safety database. Already in February 2021, the industry demanded an extreme rethink of the existing plans. These will, according to their figures, cost the industry £1 billion.

During 2022, the government will begin consultations with all stakeholders. This will be about extending the deadlines for providing full registration data. More details will follow after the consultation rounds.

Furthermore, the need for replication of the EU REACH will be scrutinized. Replication of the EU regulations should be reduced by placing more emphasis in the new rules on understanding the uses of chemicals in Great Britain. Northern Ireland, incidentally, will remain under EU regulation.

According to The Chemical Industries Association, the extension of the REACH deadlines provides more time to work on a long-term solution. This would then be able to deliver at least the same results while reducing unnecessary costs resulting from data overlap.

Link to source page is News Story – Deadline for UK REACH to be extended

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‘Wish flouts product safety regulations’, says the French government. France has ordered search engines and app stores to ban the American e-commerce platform. The famous online marketplace platform has been subject to these exceptional sanctions.

Dangerous products

Wish will soon no longer appear in the results pages of Google or Bing, nor in the list of apps in the App Store or Play Store. Although the site can still be accessed by typing the URL directly into the browser bar, the removal from the search engines and app stores is a huge blow to the platform’s online visibility.

The government decision comes after an earlier investigation by France’s Directorate General for Competition, Consumer Affairs and Anti-Fraud (DGCCRF), reports Euractiv. That revealed that Wish offered a large number of non-compliant and dangerous products for sale. Of the toys and electrical appliances inspected, 95% were found to be non-compliant with legal requirements. Moreover, 45% of the toys and 90% of the appliances were even deemed dangerous.

The investigation also revealed that Wish did not properly fulfill its obligations as a distributor in terms of product withdrawals and recalls. The platform did take action in most cases against products deemed to be dangerous, but often they were later offered again under a different name.

Level playing field

In July, the DGCCRF gave Wish two months to comply. That didn’t happen and so the government is now having the platform removed from search engines and app stores. According to French Economy Minister Bruno Le Maire, the decision illustrates the government’s efforts to protect consumers and effectively fight against unfair competition from players who flout product safety rules.

Moreover, on French radio station Franceinfo, Le Maire stated that this was the final warning for Wish. “Either the site complies with consumer protection rules, or we will go one step further and ban the site entirely on French territory.”

France blocks Wish from Search Engines – Posted December 2021, source: Ministère de l’économie des finances et de la relance

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The European Commission has made changes to the list of harmonized standards under the Toys Safety Directive. These have been published on 16-11-2021. In this article, we summarize the standards on the list that have been amended.

The following standards are replaced with effect from 28 November 2021:

• EN 71-7:2014+A2:2018 (Part 7: Finger paints – Requirements and test methods) is replaced by EN 71-7:2014+A3:2020 (Part 7: Finger paints — Requirements and test methods)

Informative note:

For the allowed preservative Climbazole (entry 22 in Table B.1 of Annex B to this standard) the presumption of conformity applies up to a maximum allowed concentration of 0,2 % (not: 0,5 %). (As seen in the ADDENDUM)

• EN 71-12:2013 (Part 12: N-Nitrosamines and N-nitrosatable substances) wordt vervangen door EN 71-12:2016 (Part 12: N-Nitrosamines and N-nitrosatable substances)

Informative note:

The limit values in point (a) of Table 2 of clause 4.2 of standard ‘EN 71-12:2016 Safety of toys — Part 12: N-Nitrosamines and N-nitrosatable substances’ are lower than the limit values to be complied with set in point 8 of part III of Annex II to Directive 2009/48/EC.

In particular those values are as follows:

Substance N-nitrosamines

• Standard EN 71-12:2016: 0,01 mg/kg
• Directive 2009/48/EC: 0,05 mg/kg

Substance N-nitrosatable

• Standard EN 71-12:2016: 0,1 mg/kg
• Directive 2009/48/EC: 1 mg/kg

The following standards are replaced with effect from 21 February 2022:

• EN 62115:2005 (Electric toys – Safety) IEC 62115:2003 (Modified) + A1:2004
• EN 62115 :2005/A2:2011 (IEC 62115:2003/A2:2010 (Modified)
• EN 62115:2005/A2:2011/AC:2011
• EN 62115:2005/A11:2012
• EN 62115:2005/A11:2012/AC:2013
• EN 62115:2005/A12:2015

are replaced by EN IEC 62115:2020 (Electric toys — Safety) EN IEC 62115:2020/A11:2020

The following standards are replaced with effect from 15 May 2022:

• EN 71-2:2011+A1:2014 (Part 2: Flammability) is replaced by EN 71-2:2020 (Part 2: Flammability).
• EN 71-3:2019 (Safety of toys — Part 3: Migration of certain elements) is replaced by EN 71-3:2019+A1:2021 (Safety of toys — Part 3: Migration of certain elements)
• EN 71-4:2013 (Safety of toys — Part 4: Experimental sets for chemistry and related activities) is replaced by EN 71-4:2020 (Safety of toys — Part 4: Experimental sets for chemistry and related activities)
• EN 71-13:2014 (Safety of toys — Part 13: Olfactory board games, cosmetic kits and gustative games) is replaced by EN 71-13:2021 (Safety of toys — Part 13: Olfactory board games, cosmetic kits and gustative games)

Amendments Toy Safety Directive — Source: EUR-lex

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Introduction

There is a need for improved MDR compliance of older devices in the EU. There is also a need to review the requirements related to parallel imports. Therefore, the Medical Device Coordination Group (MDCG) published two guidelines on October 20, 2021. The MDCG is the expert panel of the EU member states and the EC. These guidelines are a useful manual for, on the one hand, the manufacturers, importers and distributors of so-called "legacy devices" and, on the other hand, the parallel importers. For the first group, the guidelines deal with which MDR obligations they must comply with (Guideline 2021-25). Regarding the parallel importers, the guideline mainly focuses on the repackaging and labeling of medical devices under Article 16 MDR/IVDR (Guideline 2021-26).

Guidance for MDR Conformity of Legacy Devices

Medical devices certified under the previous directives 93/42/EEC or 90/385/EEC may remain on the market for a transitional period without being certified under the MDR. This is described in Article 120(3) of Regulation 2017/745 on medical devices. The date of application of the MDR is May 26, 2021. However, there is a condition that the MDR requirements regarding surveillance and vigilance are met. Now it is the case that many medical devices are still using this transitional mechanism. So the following question arises: What monitoring and surveillance obligations specifically must be met by importers and distributors of such older devices? This question is of critical importance.

MDCG advice on existing devices and devices placed on the market before May 26, 2021

Directive 2021-25 provides guidance on the application of the MDR requirements to 'existing devices' and to devices placed on the market before May 26, 2021, pursuant to Directive 90/385/EEC or Directive 93/42/EEC. The document provides detailed guidance and, in particular, addresses the extent to which periodic safety reports (PSUR) must be prepared. Surprisingly mildly, the MDCG opinion is that manufacturers of older devices do not need to designate a PRRC for those older devices. A "Person Responsible for Regulatory Compliance" is responsible for regulatory compliance. This runs counter to the previously held, stricter view that a PRRC is necessary for older devices as well, for oversight and vigilance purposes. In view of these new guidelines, manufacturers, importers and distributors of older medical devices will need to carefully assess their current processes and adjust them as necessary.

Parallel import of medical devices

Directive 2021-26 provides additional questions and answers on the repackaging and re-labeling of devices. The title of this directive is 'Questions and answers on repackaging & re-labeling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746'

The parallel importer must notify the original manufacturer under Article 16(3) MDR/IVDR. It is notable that the MDCG considers that this does not apply to older medical devices. However, the guidelines do not address the question of whether parallel importers of older devices must notify the trademark holder of the original manufacturer. This is based on ECJ jurisprudence on trademarks for pharmaceuticals. Original manufacturers are therefore advised to:

• establish and maintain robust procedures;
• monitor and take enforcement action against non-compliant or trademark-infringing parallel trade in their medical devices.

It states that importers and distributors must have a quality management system (QMS) that ensures the accuracy of the relevant procedures. Procedures regarding the handling of non-compliant devices, market recalls and, if necessary, corrective action procedures must be defined in the QMS. In addition, importers and distributors obtain a certificate issued by a notified body certifying that the QMS meets the requirements set out in the same provision.

New MDCG guidelines for MDR compliance of older devices and requirements for parallel imports into the EU

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Some of those conditions are also mentioned in safety warnings about the device. The users want to investigate whether the use of the Dreamstation 1 has led to the health complaints in them. About 50,000 of these devices have been sold in the Netherlands. Earlier this year, the US based FDA took additional actions related to the Philips Respironics ventilators, BiPAP, and CPAP recall. You can find a link to the descriptions of those actions underneath this article. Sleep apnea is when a person’s breathing stops while they sleep. The machine then ensures that breathing continues.

Safety warning

Last summer Philips warned about problems with the sound-absorbing foam in the Dreamstation People were therefor advised to stop using the device and to contact a doctor. But for some users, sleeping without the machine was not possible for medical reasons. ‘Some of my clients are still using the device,‘ says attorney De Hek. ‘They don’t know if it’s safe, but if they stop they’ll be tired all day, have headaches, or they might fall asleep at work or in the car. So it’s choosing between two evils.’In the safety warning, Philips says it has received complaints about black particles in the mask, among other things. Users are also said to have suffered from headaches, coughing and chest pressure, among other symptoms.

Admitting liability

According to De Hek, Philips must now acknowledge liability, so that the consequences of using the device can be investigated. That investigation should be done and paid for by Philips, says the lawyer. ‘It would be the opposite world if my clients had to do this research and pay for it. Philips brought these problems into the world, so should take responsibility for them.’

He says the studies should help translate from the general warning to the situation of individual users. ‘There is a lot of ambiguity and uncertainty among my clients now.’ Should the investigations show that his clients’ health problems were caused by use of the apnea device, Philips should have to compensate for those damages, the lawyer says.

Solve the problem as soon as possible

Philips says it cannot comment on the liability claim. ‘I would like to reiterate that we take the safety notification regarding these devices very seriously and that we strive to resolve this as well and as quickly as possible,’ says a spokesperson.

Source: NOS

On September 10, 2021 the FDA has taken additional actions related to the Philips Respironics ventilators, BiPAP, and CPAP recall. For details, see FDA Actions.

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Introduction

The EU Commission has put forward a series of new proposals related to Artificial Intelligence. These are legislative and non-legislative proposals. For example, there is a ve regulation establishing rules on AI. (Artificial Intelligence Act – AIA). With this, the EC seeks to create a first, comprehensive legal framework for the rapidly developing family of technologies. The following is a summary of the groundbreaking proposal. There are 4 main topics:

1. the main policy considerations;
2. the proposed new restrictions;
3. the proposed risk classifications and
4. the related obligations for providers and users of AI arising from this proposal.

The EC plans to review the AI coordination plan with the MS. This aims to

• accelerate;
• address and;
• align with each other.

This will enable Europe to become a global leader in the development of human-centered, sustainable, safe, inclusive and reliable AI. The plan also provides an overview of both existing and planned projects related to AI at the European level. It also gives a picture of the various funding opportunities. These include the new “Facility for Recovery and Resilience”. This provides for a 20% digital spending target at Member States level.

Furthermore, the EC has made a proposal to revise the regulatory framework for machines. AI technologies (built into both consumer and professional products) must now be taken into account. The new machinery regulation will replace the current machinery directive (2006/42/EC). The aim is first to ensure safety and further to introduce an EU-wide conformity assessment when placing such AI-enhanced products on the EU market.

Status quo of the EU policy debate

The AIA proposal follows the EU’s standard legislative procedure (i.e., the “ordinary legislative procedure”). It is now being debated in parallel in the European Parliament (EP) and the Council. The complex and far-reaching nature of the AIA proposal will undoubtedly lead to lengthy negotiations. These are likely to last well into 2022. The European Parliament sees the need to create a regulatory framework that defines the restrictions on AI technologies and robotics. In particular, there will be a well-defined legal liability regime for products and services that use AI.

1. The Slovenian Presidency of the Council will host a high-level conference on AI in September 2021;
2. Maintain a competence over the legislative file regarding:

• the high level expert group on artificial intelligence;
• the High Level Expert Group on the impact of digital transformation on EU labour markets;
• or the expert group on liability and new technologies;
• The associated committee, in addition to the Committee on Industry, Research and Energy (ITRE).

IMCO Committee rapporteur Brando Benifei (S&D Group, Italy) hopes that the EU Parliament can approve its negotiating mandate by the end of 2021. That seems very ambitious given the complexity of the AIA proposal.

There will be provisions that could affect the fundamental rights of citizens. Consider, for example, remote biometric recognition. Of these, it is expected that the European Parliament will take an aggressive stance. It is also possible that the EP will propose to ban even more AI practices in the EU. Also, in some cases, it will start challenging the self-certification capabilities of high-risk AI providers.

The EU Council has been discussing the proposed AIA at a technical level. Last June, the Council of Ministers already exchanged views on the AIA proposal for the first time. Top priority is given to the Slovenian Presidency. It aims to reach a general approach by the end of its mandate (in December 2021). However, it can be expected that these complex deliberations will last well into 2022 [1].

In that case, it will be up to the French Presidency of the Council to pursue that general orientation. It is even possible that its conclusion will be during the period of the Czech Presidency. Some EU member states share industry concerns about the potential impact of the AIA on competitiveness and innovation. A number of other member states are particularly concerned about the potential of AI systems to support law enforcement, counterterrorism, and the like.

The new artificial intelligence act (AIA)

From a policy perspective, the EC recognizes the benefits that AI can play in society. Those benefits range from, for example, better medical care to better education. However, the EC also believes that some AI systems carry risks. A new regulatory framework is needed to protect users without limiting technological developments. The EC also hopes to create more clarity and legal certainty around AI. With this, trust and excellence in AI solutions can be established. This will not only encourage their adoption and expansion in the EU, but it will also prevent regulatory fragmentation of AI systems.

There are already several AI-enhanced products and services on the EU market. So now the EC has proposed the world’s first comprehensive regulatory regime for AI. That proposal incorporates feedback from external stakeholders and expert groups [2].

The scope of AIA, new EC proposals.

The scope of the proposed AIA [3] (Title I) includes providers that market or provide service for AI systems, regardless of whether these providers are located inside or outside the EU. Users of AI systems are covered under the new rules only if they are located in the EU.

AIA will apply even if the provider and user are located outside the EU, but the output produced by those systems is used in the EU. Some examples are:

• providers of AI systems, (e.g. a developer of a CV screening tool);
• Users of such AI systems, (e.g., a large employer who purchases this CV screening tool);

The AIA will not apply to non-professional use. Also exempt are systems developed and used solely for military purposes.

Risk categorization

The EC proposes a risk-based categorization of AI systems. In doing so, they use 4 levels of risk, the corresponding legal obligations and the corresponding legal restrictions:

AIA, new EC proposals – Risk level No. 1 – Unacceptable risk (Title II)

A small number of particularly harmful AI systems that violate the values of the EU are prohibited because they violate fundamental rights [4]. These include

• “social scoring” by governments;
• the exploitation of vulnerabilities of children or otherwise disabled people;
• the use of subliminal techniques that can cause physical and psychological harm;
• live remote biometric identification systems in publicly accessible areas used for law enforcement purposes. However, some exceptions do apply to this category.

AIA, new EC proposals – Risk level No. 2 – High risk (Title III, Annex III)

Article 6 defines “high risk” AI systems as systems

• where the AI system is intended to be used as a safety component of a product, or is itself a product
• and that product is subject to an existing third party conformity assessment (e.g. motor vehicles, trains and aircraft).

In addition, the EC has the power to directly designate an AI system as a high-risk system by adding it to Annex III of the AIA. However, certain criteria must then be met. The EC proposes to review the list of covered systems annually. This is in view of the rapid evolution of high-risk AI use scenarios.

The EC would adopt delegated acts to amend the list of high-risk AI systems in Annex III.

Annex III contains a number of cases of AI applications that can (potentially) have a negative impact on people’s health, safety or fundamental rights. These cases are therefore designated as “high risk”. Such cases include AI systems that, for example

1. use biometric identification;
2. manage or operate critical infrastructure;
3. are used for education or vocational training;
4. are used for recruitment or personnel or work-related tasks;
5. determine access to essential private and government services, including benefits, ;
6. be used in a law enforcement context;
7. be used in a migration, asylum or border management context or;
8. are used in the administration of justice or democratic processes [5].

High-risk AI systems can only be placed on the EU market or put into operation if they meet certain minimum requirements. In doing so, providers must subject the system to a prior conformity assessment. Also, that assessment must be repeated if there are significant changes to the AI system. In certain cases, an independent notified body must be involved in that assessment.

Even after the product is placed on the market, providers of AI systems must implement quality and risk management systems. This is to ensure that they

• comply with the new requirements;
• To minimize the risk to users and affected persons.

Market surveillance authorities will support post-market monitoring through audits.

For high-risk AI systems, the EC proposes a set of new mandatory requirements (Title III), including:

1. The establishment of a risk management system (Art. 9), which in a continuous and iterative process manages the risks associated with the AI system;
2. quality criteria for the sets of training, validation and testing data used (Art. 10);
3. technical documentation describing, among other things, the AI system’s compliance with applicable requirements, including for law enforcement purposes (Article 11)
4. record keeping requirements to ensure an appropriate level of traceability of the operation of the AI system (Article 12)
5. transparency and information provision to enable users to interpret and appropriately use the output of the system (Article 13);
6. The systems are effectively under human supervision (Article 14) – The systems must achieve an appropriate level of accuracy, robustness and cyber security throughout their life cycle (Article 15) The following new obligations apply to providers and users of high-risk AI systems, among others;
7. General obligation to comply with the above list of requirements – Maintain a quality management system (Art. 17) – Ensure that their systems go through the relevant conformity assessment procedure (Art. 19);
8. Maintain automatically generated logs (Art. 20);
9. Obligation to take corrective action when the AI system does not comply with the AIA (Art. 21), obligation to report serious incidents or malfunctions to the competent national authorities (Art. 22) and obligation to cooperate with those authorities (Art. 23);
10. Specific requirements apply to importers of high risk AI systems (Art. 26), as well as distributors (Art. 27) and users (Art. 29) The EC will establish a publicly accessible register of high risk AI applications and systems (Art. 60).

AIA, new EC proposals – Risk level No. 3 – Limited risk (title IV)

Certain AI systems will only be subject to new transparency requirements (Title IV). This is for example when there is a risk of manipulation (e.g. chatbots) or deception (e.g. deep fakes). Natural persons must be aware that they are interacting with an AI system, unless this is clear from the circumstances and context of use.

Exceptions exist for law enforcement purposes.

AIA, new EC proposals – Risk level No. 4 – Minimal risk

All other AI systems can be developed and used in compliance with existing law without new legal obligations through the AIA. According to the EC, a large number of AI systems currently in use in the EU fall into this category. The EC recommends voluntary codes of conduct for providers of such AI systems.

Monitoring/Enforcement (Title VI)

The proposed enforcement measures provide for penalties of up to €30 million or 6% of global revenue (whichever is higher) for the most serious violations of the new regime. This makes the penalty regime even more draconian than that for violations of the General Data Protection Regulation (GDPR). This is the case for the use of prohibited AI systems and the violation of data management provisions when using high-risk AI systems.

All other cases of non-compliance with the AIA are subject to a fine of up to 20 million euros or 4% of global turnover (whichever is higher). Merely providing false, incomplete or misleading information to the competent authorities is already liable to a fine of up to 10 million euros or 2% of global revenue.

MS authorities will play a key role in the application and enforcement of the new AI regulatory regime. Newly designated national AI supervisory authorities will oversee the application of the AIA and conduct market surveillance activities. A new European Artificial Intelligence Council will be established at the EU level, which will support and guide the EC and national authorities in their relevant activities

Enforcement rests with the Member States. This is also the case for the GDPR. It can be expected that sanctions will be introduced gradually. In doing so, enforcement efforts will initially focus on those who do not seek to comply with the regulation. It is also to be expected that there will be a lot of material on how to comply with the regulation, as well as interpretative notes.

AIA, new EC proposals: the potential impact on the industry

Somewhat similar to the GDPR, the AIA proposal in its current form will have extraterritorial reach. As such, it could potentially affect a large number of companies with customers located in the EU. The regulation is in the midst of the EU legislative process, so it is not yet set in stone. However, the direction suggested by the EC is clear.

The proposed AI regulatory scheme worldwide is the first of its kind. Therefore, many experts expect it to have a major impact on other regions of the world. This is called the “Brussels effect” [6] (similar to what was experienced after the adoption of the GDPR). Therefore, it is all the more important that all stakeholders get involved in the debate now in order to create an adequate EU regime for AI.

It is critical is to participate in the current regulatory and policy debate. Yet many organizations will also need to start preparing for the new AIA and the risks associated with the new AI rules.

What is the next step?

The debit surrounding the legislative process on the AIA proposal will last until 2022. In addition to the current legislative debates, the EC will come up with additional legislative measures related to AI in 2022. These are aimed at adapting the liability framework to apply to emerging technologies. Most likely, these will include

• a revision of the Product Liability Directive;
• a legislative proposal related to the liability of AI systems;
• adjustments to existing sectoral safety legislation (including the General Product Safety Directive or the Radio Equipment Directive).

Importantly, in 2021 the EC will publish a policy program to implement Europe’s digital compass. This will cover a wider range of policies relevant to aligning the EU’s digital ambitions for 2030. It will include a roadmap setting out

• the general principles and commitments that Member States will be advised to follow;
• concrete actions needed to achieve the policy goals.

The use of AI systems is cited as one of the key areas to be developed to achieve the EU’s 2030 digital ambitions. Three quarters of European businesses should use cloud computing services, big data and AI solutions.

The EU plans to set the standards that will pave the way for ethical technology worldwide. At the same time, the EU needs to remain competitive. The industry has expressed deep concern about the far-reaching impact the future law will have on their businesses. This is evident from the public consultation on the proposed AIA. Not only will the AIA create unnecessary and burdensome compliance obligations in the eyes of much of the industry. It will also be very costly to industry.

In contrast is the view widely shared by civil society, trade unions and data protection authorities. They share the conviction that the proposed law does not go far enough. In their view, there should be tighter restrictions on high-risk AI use and compliance obligations for AI systems. Either way, for now it remains an open question whether the proposed AIA is going to become a de facto global standard.

The EU legislative process will lead to the first significant regulation of AI systems worldwide and any company that wants to do business in or with the EU will have to comply. That much seems certain by now. The legislative proposal is the basis on which the EC will continue to formulate its future policies around the various facets of AI. AI systems are constantly evolving. Therefore, it is difficult to guarantee that the legislative framework will be future-proof. However, this stage of the legislative process is the ideal time to understand the direction in which the negotiations will go. After all, now the technical elements of the bill are being discussed. It provides ample opportunities to engage with policymakers and thus influence this critically important new AI legislation.

AIA, new EC proposals: the current legislative phase

An organization will need to familiarize itself with what the new AI regulatory regime may mean. What steps can be taken now to anticipate and manage the new regime. Such steps may include the following:

• An inventory of all AI systems used by the organization;
• A risk classification system;
• Risk mitigation measures;
• Independent audits;
• Data risk management processes;
• An AI governance structure;

FOOTNOTES

• [1] The Slovenian Council Presidency will host a high-level conference on AI on September 13-14, 2021.
• [2] E.g. the High-Level Expert Group on Artificial Intelligence; the High-Level Expert Group on the Impact of Digital Transformation on EU Labour Markets; or the Expert Group on Liability and New Technologies.
• [3] A regulation is an EU legal instrument that will be directly applicable in all EU member states and thus must take another step at the national level to become applicable law.
• [4] E.g., the Charter of Fundamental Rights of the EU.
• [5] See AIA, Annex III, for details.
• [6] “The Brussels Effect – how the European Union rules the world”, by Anu Bradford, Oxford Pres

Source: The National Law Review

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The amendments to harmonised standards under the Pressure Equipment Directive (PED) are published in an executive order. These took effect on October 11, 2021. It covers the harmonized standards for:

• metallic industrial piping systems;
• bolted connections for flanges and their joints;
• flame tube boilers made of corrosion-resistant steel.

Article 12 of Directive 2014/68/EU

In accordance with Article 12, pressure equipment or assemblies thereof [1] shall be presumed to conform to the essential safety requirements [2].

[1]: Article 4(1) and (2) refer to assemblies which are in conformity with harmonized standards or parts thereof. The references have been published in the Official Journal of the European Union.

[2] The conformity is with the essential safety requirements described in Annex 1 to the Directive covered by the standards (or parts thereof).

In 1994, the EC made a request (M/071) to the European Committee for Standardization (CEN). In that request, the CEN is asked to draw up both product-related standards and the standards of a horizontal nature in connection with pressure equipment. This is in support of Directive 97/23/EC. Because when that was replaced by Directive 2014/68/EU, the essential safety requirements in Annex 1 did not change.

Standards amended and revised by the CEN

CEN has amended some existing standards. This was done based on the request M/071 and to reflect the state of the art.

Concerning bolted connections for flanges and their joints: The old harmonized standard from 2009 has been replaced by a new harmonized standard (EN 1515-4:2021).

Flame arresters made of corrosion resistant steel: The old harmonized standard from 2003 has been replaced by a new harmonized standard (EN 14222:2021).

Regarding metallic industrial piping systems, the harmonized standard EN 13480-3:2017 has been amended.

Furthermore, CEN together with the Commission verified the compliance of the above measures with request M/071.

Official Journal of the European Union about the amendments Pressure Equipment Directive

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What if a manufacturer delivers machines without controls because the customer takes care of this himself or by others? The manufacturer has tags in use with and without the CE mark.

The questions that may arise in a case like this are:

1. Which tag should a manufacturer use in the above situation? Should the manufacturer place a nameplate with or without a CE mark on a machine without control? It is clear that another party takes care of the control of the machine and ensures with its hardware and software that the motors and drives eventually can move.
2. Does it make sense to affix a CE mark since the machine must ultimately be declared CE-worthy by another party? Or does the customer have to take care of this himself? It can also happen that the manufacturer delivers a production line or part thereof to a customer.
3. Is the manufacturer compelled to provide each machine with a type plate separately? After all, the manufacturer is not responsible for the total CE marking of the production line. Does the manufacturer provide unfinished machinery?

What is ‘unfinished machinery’ according to the Machinery Directive?

It is often thought that as long as the machine does not have control it cannot produce anything anyway and that it is then a so-called “incomplete machine”.

Definition g) in article 2 of the current directive (2006/42/EC) reads:

• “Incomplete machinery” means an assembly that almost forms a machine but that cannot independently realize a given application.
• A drive system is an incomplete machine.
• An incomplete machine is intended only to be incorporated into or assembled with one or more other machines or other incomplete machine(s) or equipment, to form a machine to which this Directive applies;

A key role in determining whether there is an incomplete machine or a completed machine is reserved for the word ‘specific application’. The current interpretation of the Machinery Directive is set out in the document ‘Guide for the application of Machinery Directive 2006/42/EC – 2th edition – June 2010’ and in this the following is written about ‘specific application’:

‘Typical machinery-specific applications include, for example, the processing, treatment, or packaging of materials, or the moving of materials, objects or persons.’

When a manufacturer is supplying their customer with a machine that will surely achieve a ‘specific application’ if fitted with a correct control system, the question of CE-labelling arises. In many cases, the manufacturer would deliver it to their clients with a CE mark when the machine indeed was fitted by a control system that the manufacture provided internally.

Such examples often occur with larger users in the process industry who purchase several machines and want to control them from one and the same basic process control system (BPCS). Think, for example, of a so-called ‘reaming bridge’ or auger press that is supplied to a sewage treatment plant.

When the user is provided with a working machine that is equipped with all the necessary drives, motors, and sensors, which can perform its specific application simply by using its own switch box with control, the manufacturer will also be expected to provide the user with time sequence diagrams and all the necessary information to enable correct control. There is a separate definition for such a machine in the current Machinery Directive under a) second indent.

Definition a) second indent:

‘an assembly referred to in the first indent, missing only the components to connect it on-site or to sources of energy and motion.‘

Based on the above analysis, the answer to the first two questions is that the manufacturer must supply their machine without a controller with CE marking. However, the manufacturer will be well advised to provide a clear annex to the EC Declaration of Conformity stating the safety conditions under which the CE marking is valid.

Looking into CE marking for your products? What are the biggest frustrations and questions? Start by watching one of our videos HERE.

Does a manufacturer who delivers a machine that will later be built into a production line need to provide the CE marking?

It is often thought that a machine builder who delivers a machine that will later be built into a production line must deliver this machine without CE marking. This thought stems from the last line of the definition of ‘incomplete machine’:

‘Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies’

Unfinished Machinery

Reading this, one might conclude that any machine that is assembled with one or more machines to eventually form a production line should be delivered under the heading of ‘partly completed machinery’. However, this is an incorrect idea because an incomplete machine must be a machine that ‘cannot independently’ fulfill its specific application.

According to the ‘Guide for the Application of the Machinery Directive 2006/42/EC – 2nd edition – June 2010’ this means the following:

Partly completed machinery subject to the Machinery Directive is a product intended to form machinery that is in the scope of the Machinery Directive after incorporation.

‘An assembly which is almost machinery’ means that partly completed machinery is a product that is similar to machinery in the strict sense referred to in Article 1 (1) (a), that is to say, an assembly consisting of linked parts or components at least one of which moves, but which lacks some elements necessary to perform its specific application. Partly completed machinery must thus undergo further construction in order to become final machinery that can perform its specific application.

As an example, industrial robots are usually designed without a specific application until incorporated into the final machinery – see Article 2(g) of the Machinery Directive. The manufacturer of the final machinery takes the necessary measures so that the robot can perform its specific application safely within the assembly. In practice, only an industrial “stand and function alone-robot” provided with both an end-effector and control system so that it can itself perform a specific application, is a complete machinery under the Machinery Directive.

This further construction is not the fitting of a drive system to machinery supplied without a drive system where the drive system to be fitted is covered by the manufacturer’s conformity assessment – see §35: comments on the first indent of Article 2 (a) – or the connection on site or with sources of energy or motion – see §36: comments on the second indent of Article 2 (a). Partly completed machinery should also be distinguished from machinery ready to be installed on a means of transport or in a building or a structure – see §37: comments on the third indent of Article 2 (a).

Machinery that meets the definition in the first three indents of Article 2(a) so it can in itself operate independently, performing its specific application – see §35: comments on the first indent of Article 2 (a) – but which only lacks the necessary protective means or safety components, such as guards, is not to be considered as partly completed machinery. Such incomplete machinery does not meet the requirements of the Machinery Directive and must not be CE marked and cannot be placed on the EU/EEA market – see §103: comments on Article 5 (1).

If a machine is purchased by an end-user to be incorporated into a production line, it may be that it is explicitly required that the machine not be equipped with the necessary protective devices on the input and output sides. This is because the machine will be tightly packed.

As is clear from the above explanation the manufacturer must provide the machine with a nameplate with CE marking. It is wise to include a clear annex to the EC Declaration of Conformity stating under which safety conditions the CE marking is valid.

In the article ‘Unfinished Machinery: Who Is Responsible For CE Marking?’ the guide mentioned below is consulted as well as Machinery Directive 2006/42/EC.

Guide for the Application of the Machinery Directive 2006/42/EC – 2nd edition – June 2010.

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The UK government stated earlier this month that the start date for new import regulations for products entering into the country from the EU will be delayed.

Import restrictions had been postponed until October 1, 2021. This three-month extension of the application period means that full customs declarations and controls will be implemented on January 1, 2022. New safety and security declaration controls, on the other hand, will not be necessary until July 1, 2022.

It is important to note that this time frame only applies to the controls on import documents. Physical inspections of food products and loads, as well as export documents such Export Health Certificates, have already been postponed from January to July 2022. In more detail, the amended schedule will go into effect as follows:

Changes to take effect on January 1, 2022

• Pre-notification of Sanitary and Phytosanitary (SPS) commodities; and
• comprehensive customs declarations and controls (extended from 1 October 2021).

Changes to take effect on 1 July 2022

• the new requirements for Export Health Certificates (extended from 1 October 2021);
• Phytosanitary Certificates and physical checks on SPS goods at Border Control Posts (extended from 1 January 2022); and
• safety and Security declarations on imports (extended from 1 January 2022).

The deadline for new product labeling laws has not been pushed back since it already included a generous transition period, with producers free to use an EU, GB, or NI address for products sold in the UK until September 30, 2022. However, beginning October 1, 2022, pre-packaged goods supplied in the United Kingdom must include the food business operator’s (FBO) GB address or, if the FBO is not situated in the United Kingdom, the name and address of the importer.

Since 1 January 2020, British exports to the EU have been subject to regulations, but the government has opted to take a phased approach on EU imports to give hauliers and businesses more time to adjust. The UK Government cites a need to give food and drink industries more time to focus on COVID-19 recovery measures, and it was determined that imposing new import regulations at such a sensitive moment for the industry would be an unfair burden.

UK food importers relieved

Importers of EU food products in the United Kingdom may be relieved by this announcement. EU markets account for roughly a quarter of all UK food imports, and there is a strong drive for regulatory changes to be phased in over time for food businesses that rely on imported products or ingredients from the EU. Indeed, Marks and Spencer, the UK supermarket chain, warned suppliers in an open letter (first reported in The Times) that there is a “real danger of disruption and delay at the EU-GB border that will lead to significant food waste across the sector, reductions in range and availability, and inflationary pressures” unless things are simplified.

UK industry representatives have strongly objected against the delay

Industry representatives, on the other hand, have slammed the announcement, claiming that it exacerbates the unfair playing field between EU and UK companies. In summary, the delay produces one-way traffic, in which UK firms selling to the EU are subject to stringent regulatory requirements, whilst EU exporters to the UK can take advantage of less stringent regulatory procedures due to the continuous delay in the implementation of import controls.

Source: Brodies LLP — Grant Strachan and Charles Livingstone

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Every year on 14 October, the members of the IEC, ISO and ITU celebrate World Standards Day. WSD pays tribute to the collaborative efforts of thousands of experts worldwide who develop the voluntary technical agreements that are published as International Standards.

World Standards Day 2021 is about our shared vision for a better world.

Message from IEC, ISO and ITU:

WORLD STANDARDS DAY 2021 — STANDARDS FOR SDGS

OUR SHARED VISION FOR A BETTER WORLD

The Sustainable Development Goals (SDGs), which project to address social imbalances, develop a sustainable economy, and slow the rate of climate change, are highly ambitious. To reach them will require the cooperation of many public and private partners, and the use of all available tools, including international standards and conformity assessment.

The intense battle against a persistent global pandemic revealed the absolute necessity of addressing the SDGs in an inclusive way, to strengthen our societies, making them more resilient and more equitable. Today, we are asking you to join us on a mission that affirms the importance of the SDGs to build back better. In this pursuit, standards are more relevant than ever.

The entire standards system is built on collaboration. It is testament to the power of cooperation and the belief that we are stronger than the sum of our parts. By working together, we are empowering people with real-world solutions to face sustainability challenges head-on.

It is in this spirit that we are engaging in a multi-year World Standards Day journey that showcases the many ways in which international standards contribute to the success of the SDGs.

We stand united to work together to accelerate the 2030 Agenda, with standards for the SDGs, and our ‘Shared vision for a better world’.

Source: ISO – message about World Standards Day 2021

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Contents:

• What is a Responsible Person, and what is it’s role?
• How to making cosmetic products safe for users.
• Labelling cosmetic products.
• The notification procedure at the Office for Product Safety and Standards for cosmetic products.
• What to do to keeping users of cosmetic products safe.

On October 4, 2021, the UK government published general guidance that deals with the marketing of cosmetic products in the UK. These products must meet conditions set by the government. This includes all cosmetic products that are available to both professional users and the public. Not only the goods purchased by consumers, but also those received by consumers (e.g. free samples).

However, this guide does not cover Northern Ireland regulations. Separate technical guidelines apply to that. Also, in that case the responsible person will have to be based in Northern Ireland itself, or in the EU.

All cosmetic products available to consumers must have a “responsible person”. This person will ensure that safety measures are adhered to and that legal obligations are met. This can be a company or an individual (including sole traders). A responsible person must have a UK-based address to offer cosmetic products in GB. Mail forwarding or PO Box addresses are not accepted.

A responsible person may be

• the manufacturer;
• the importer;
• the distributor, if he labels the product as his own (for example, by using his brand name);
• a designated company or person (named by the manufacturer or importer).

What does a responsible person do?

Who ensures that the cosmetic products he makes available are safe. This means that the responsible person:

• knows what ingredients are used in their cosmetic product, including harmful ingredients or nano-materials;
• is aware of the restrictions on what can be used in cosmetic products;
• has an updated document keeping information about the cosmetic product (called the “Product Information File” or “PIF”);
• clearly displays all information on the cosmetic product’s packaging, labeling and instructions for use;
• notifies the Office of Product Safety and Standards (OPSS) of the cosmetic product (called notification) before it is offered to the consumer;
• notifies the OPSS of any serious adverse effects reported about the cosmetic product;
• can demonstrate that the claims made at the time of marketing the product are accurate.

Looking for a Responsible Person? Alura Group can help.

The Product Information File

Cosmetic products must be safe for human health. The Product Information File (PIF) contains information about the safety of a cosmetic product to human health.

The PIF supports the safety of cosmetic products by providing

• a safety assessment, which confirms that a cosmetic product is safe and provides the scientific evidence that confirms this;
• details of good manufacturing practices, which indicate what has been done in the production of a cosmetic product to ensure that it is safe;

Making cosmetic products safe for users also relates to how a cosmetic product is presented. It should

• not be confused with food;
• have clear labeling;
• contain instructions for use and disposal;
• the Product Information File (PIF).

The responsible person must maintain a PIF in English for all their cosmetic products. The PIF contains

• a description of the cosmetic product;
• the product safety report;
• how good manufacturing practices were followed;
• evidence of how the cosmetic product works;
• the PIF must be kept for ten years after the last batch of the cosmetic product was made available.

The Product Safety Report.

Before a cosmetic product reaches the consumer, its safety must be verified by an independent safety assessor. The Product Safety Report consists of 2 parts and is part of the PIF.

The two parts of the product safety report are:

• The cosmetic product safety information (Part A). This is provided by the responsible person.
• The cosmetic product safety assessment (Part B). This is provided by the safety assessor.

The cosmetic product safety information (Part A)

The cosmetic product safety information (Part A) contains all the data necessary to perform a cosmetic product safety assessment. It may be necessary to conduct or organize tests on a cosmetic product to complete this section. Part A contains information about:

• the ingredients, their concentrations, chemical names and toxicological properties;
• the physical and chemical properties of the ingredients and the finished cosmetic product;
• the stability of the product;
• any microbial contaminants in the ingredients or in the finished product;
• how preservatives prevent microbial contamination of the product;
• any impurities;
• what has been used to package the product;
• how the cosmetic product is likely to be used;
• the amounts of ingredients and finished product to which the user could be exposed.

The cosmetic product safety information (Part B)

The cosmetic product safety assessment (Part B) are the conclusions of the safety assessor in relation to Part A. They include

• an assessment of the safety of the product;
• any necessary warnings or instructions for the product;
• the scientific justification for the conclusions of the safety assessment;
• the safety assessor’s details, including name, address and proof of qualifications.

How do you have the safety of a cosmetic product assessed?

The product safety assessment is conducted by a qualified professional. This is someone who has a university degree in pharmacy, toxicology, medicine or a similar discipline. It is the responsibility of the responsible person to ensure that the safety assessment is performed by a qualified safety assessor.

Good manufacturing practices for cosmetic products

“Good manufacturing practices” must be observed in the production of cosmetic products. This involves how the reproducibility and quality of a cosmetic product is ensured when it is made. Good manufacturing practices can be demonstrated by complying with the relevant designated standard ISO 22716. Good manufacturing practices for cosmetic products are different from good manufacturing practices for pharmaceutical products.

How can good manufacturing practices be met?

ISO 22716 describes practical things that can be done to implement good manufacturing practices. It is not the only way to demonstrate that good manufacturing practices are being applied. ISO 22716 says that the company that manufactures cosmetic products:

• Ensure that all employees know their roles and responsibilities with respect to the production, control, storage and shipping of cosmetic products;
• ensure that personnel have the appropriate training and skills for the production of cosmetic products;
• ensure that the place where cosmetic products are manufactured is regularly maintained and cleaned;
• Ensure that the place where the cosmetic products are manufactured is arranged in such a way as to reduce the risk of mixing of products and raw materials;
• ensure that the equipment used for manufacture is regularly maintained and prevented from contaminating cosmetic products;
• have comprehensive information on raw material supply chains so that any problems can be traced;
• ensure that all water used in the manufacture of cosmetic products is adequately treated and routinely tested for microbes and impurities;
• have detailed information on how the cosmetic product was produced;
• know where in the production process the quality of cosmetic products should be tested;
• give a cosmetic product a batch number and label;
• check all equipment and the place where the cosmetic product is manufactured before manufacturing to minimize contamination;
• ensure that the quality of the product is maintained during storage, shipment and return;
• record and account for changes in the manufacturing process;
• use quality control as a means of verifying whether a cosmetic product, its raw materials, or the items used for packaging change unexpectedly;
• know and define the different types of waste generated during manufacturing;
• identify waste and dispose of it in a controlled and hygienic manner;
• investigate any complaints or problems with a cosmetic product. (What measures should be taken to prevent recurrence of problems?);
• Conduct internal audits to ensure that these steps (defined in ISO 22716) are being performed correctly;
• ensure that up-to-date documentation is in place to demonstrate what happens during the manufacturing, quality control, storage and shipping of cosmetic products.

What can and cannot be put in cosmetic products

If colorants, preservatives or UV filters are used, the applicable restrictions or prohibitions must be followed. This is a positive list, meaning that only substances from Annex 4, 5 or 6 may be used.

Carcinogenic, mutagenic or reprotoxic substances (CMR substances)

The use of CMR substances in cosmetic products is prohibited. For CMRs of category 2, exemption can be requested by industry. Category 2 CMRs are evaluated by a scientific advisory group and if found to be safe, may be used. Category 1A and 1B CMRs are evaluated by a Scientific Advisory Group only if the criteria of Article 15 are met.

Further information can be found on the Health and Safety Executive’s (HSE) chemical classification page. This page contains the GB Mandatory Classification and Labelling List, which provides information on the CMR classification of chemicals.

New ingredients used as dyes, UV filters or preservatives

For all new ingredients used as dyes, UV filters or preservatives, and thus not listed in Annex 4, 5 or 6, a safety dossier must be submitted to OPSS for a safety assessment. This also applies to nano-materials.

There are technical guidelines on what must be submitted in a safety dossier for nano-materials. Also, there is an at must submit a safety dossier for all other ingredients. There is also a checklist of the information that must be included in a safety dossier.

Safety dossiers should be submitted to the OPSS Safety Assessment inbox: [opss.safetyassessment@beis.gov.uk](https://opss.safetyassessment@beis.gov.uk).

How to notify OPSS about nano-materials?

A notification of nano-materials are made for cosmetic products containing nano-materials not listed in Annex 4, 5 or 6 that are used for a purpose other than as a preservative, UV filter or colorant. This is done through the cosmetic products notification submission service.

For cosmetic products containing nano-materials listed in Annex 4, 5 or 6 and used in accordance with the restrictions, further information is required as part of the cosmetic product notification.

The following cosmetic product notification service guidelines explain how to submit notifications of products containing nano-materials.

Labeling of cosmetic products

The labeling of cosmetic products must be easily legible. The container and any packaging must indicate the following

• the name and address of the responsible person;
• the country of origin if the product is imported into the UK;
• the weight or volume;
• the date until which the cosmetic product can be used;
• any precautions for use;
• an identification number (e.g. lot number);
• what the cosmetic product does;
• the ingredients – these can only be listed on the packaging. Note: ingredients of nano-materials must be followed by “(nano)”;
• In some cases, the date of use and the weight or volume are not required, for example when the content is less than 5 grams or 5 milliliters. This may apply to free samples and single-use packages;
• If there is no space on the package to list precautions and ingredients, it is important that this information be stated otherwise, such as in a package insert. A symbol should be used to indicate where this information is located;
• The labeling and advertising of cosmetic products should not give the impression that they have characteristics or functions that they do not.

Making claims about what a cosmetic product does

The labelling and advertising of cosmetic products must not imply they have characteristics or functions which they do not have.

Notifying the Office for Product Safety and Standards about a cosmetic product

Before a cosmetic product is made available in GB, the Responsible Person must submit information on the cosmetic product to OPSS. This process is called notification.

How to notify OPSS about a cosmetic product

Notifying OPSS about a cosmetic product can be done using the Submit cosmetic product notifications service. Further information, including access to the service, can be found on the Submit a cosmetic product notification guidance page.

Keeping users of cosmetic products safe

Adverse reactions to cosmetic products

If a user of a cosmetic product has a reaction which results in them being temporarily or permanently unable to carry out their usual day-to-day tasks this must be reported to OPSS immediately as a serious undesirable effect (SUE). Examples of the effect that must be reported include disability, hospitalisation, congenital abnormalities, risk to life, and death.

Forms to fill out for SUEs can be found on the Cosmetic products: reporting SUEs page. Further details must be provided on:

• the Responsible Person
• all serious effects the user experiences
• the name and batch number of the cosmetic product
• any corrective measures taken

All SUE forms must be submitted to seriousundesirableeffects@beis.gov.uk.

Effects on users that do not prevent them from doing their day-to-day tasks do not need to be reported. For example, allergic reactions, irritation, and cosmetic acne.

Safety concerns about substances in cosmetic products

There may be situations where there are serious concerns about the safety of substances in cosmetic products. If this is the case the Responsible Person may be asked by OPSS to provide:

• the cosmetic products containing this substance
• the concentrations of this substance in associated cosmetic products

Making information accessible to the public

If requested by a member of public, the Responsible Person must provide:

• the list of ingredients of the product – this is sometimes called the qualitative composition
• information on amounts per unit weight or volume for any hazardous ingredients such as CMRs – this is sometimes called the quantitative composition
• data on undesirable effects and serious undesirable effects (SUEs)

The information provided must maintain commercial secrecy and intellectual property.

Based on the information provided by the UK Government. Source: www.gov.uk for further information, subscription-forms and government links .

What Do You Need To Do To Sell Cosmetic Products In Great Britain

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What is the proposal?

The (outgoing) Minister of Infrastructure and Water Management has submitted a proposal to the Dutch Parliament to introduce specific Dutch requirements. Probably the reason for this proposal can be traced back to a fatal accident that took place September 20, 2018. Four young children were killed in an accident with a so-called Stint. After extensive investigation by the NFI, an inspection SZW and investigation by the OM, the conclusion is that the driver of the vehicle is not responsible for the fatal accident. This may have been the reason for the proposal for specific Dutch requirements.

The motion relates to electric carrier bicycles, electric scooters and self-balancing vehicles with steering wheels. Self-balancing vehicles without steering wheels (monowheels, electric skateboards, etc.) will simply remain prohibited on public roads.

The plan identifies 4 categories:

1. 1a) e-(cargo) bikes lighter than 55 kilograms;
2. 1b) all other LEVs lighter than 55 kilograms;
3. 2a) freight LEVs that are heavier than 55 kilograms;
4. 2b) LEVs for passenger transport that are heavier than 55 kilograms.

For each category, the proposal includes requirements

• for approval and supervision;
• for admission to the road; and
• for use on the road.

What will change according to the motion?

For category 1a, there will be a limitation for the maximum width. A cargo bike may henceforth be a maximum of one meter wide. Vehicles in this class will be allowed on public roads without additional approvals. This is the only change from the current regulations for this group.

For groups 1b, 2a and 2b there will be an approval and monitoring procedure. This will be fully entrusted to the RDW. The RDW may make the rules, approve the vehicles and then also supervise them. The RDW has already drawn up the technical requirements. On Thursday, September 30, these requirements will be presented to a group of stakeholders. The general explanation of the technical requirements states that “according to other European regulations, these vehicles cannot be admitted to road traffic, which therefore implicitly means that they are prohibited“, according to the Dutch Ministry of Infrastructure and Water Management.

What are the legal objections according to LEVA-EU?

According to LEVA-EU, this conclusion is incorrect and the industry association therefore categorically disputes this final judgment. Its analysis shows that the proposal to subject certain vehicles to national approval is actually contrary to European regulations. These are the vehicles that are excluded from Regulation 168/2013. Like conventional e-bikes, electric cargo bikes, electric scooters and self-balancing vehicles are excluded from this Regulation. These are therefore also subject to the Machinery Directive, the EMC Directive and the RoHS Directive.

The Machinery Directive states, “Member States may not prohibit, restrict or impede the placing on the market and/or putting into service in their territory of machinery which complies with this Directive.” The Dutch government has agreed; conventional e-bikes may be allowed on the road without additional requirements.

According to LEVA-EU, it is not only inconsistent and illogical to subject e-cargo bikes, e-scooters and self-balancing vehicles to additional national testing. It is also illegal, as the vehicles in question comply with the Machinery, EMC and RoHS Directives. Moreover, there are no structural safety problems with these vehicles that would warrant additional measures. In doing so, they are widely used in cities that want to replace polluting freight and passenger transport. Even after all the investigations that were done as a result of the fatal Stint accident, this has not been proven.

What are some other objections according to LEVA-EU?

The above objections to the Dutch LEV Admission Framework are all of a legal nature. But in addition, LEVA-EU is very concerned about the proposed categorization. The plans regarding dimensions and weights are also cause for concern.

“These proposals significantly complicate the lives of electric cargo bike manufacturers, while not being based on sound safety considerations”, said LEVA-EU manager Annick Roetynck. “Determined LEV dimensions are determined based on the finding ‘that inadequate width of the bike lane leads to increased risk’. This is the world upside down: manufacturers around the world are required to make a purely Dutch electric cargo bike according to the width of the Dutch bike path. “

According to the trade association, this goes directly against all principles of European legislation, the internal market and the free movement of goods.

“If every member state were to introduce similar measures, manufacturers would again have to build 27 different types in order to be marketed throughout the EU, ” says the organization.

It also argues that these specifically Dutch requirements will undoubtedly have a negative effect on the supply of LEVs in the Netherlands. Manufacturers are more likely to choose markets where they can use European harmonized vehicles. The consequence of this is that there will be a contraction. As a result, the sustainability of mobility in the Netherlands will be at risk. This in turn has negative consequences in terms of emissions, combating climate change, road safety and public health.

The industry association has therefore asked the Dutch government for clarification. It would like an explanation of how these regulations serve a purpose in the Dutch public interest. The Netherlands should also inform the EC and the member states of this national initiative. So far this has not happened, at least it cannot be found in the European TRIS database.

Conclusion

LEVA-EU requests the Dutch government to abandon the LEV approval framework. All LEVs that meet the requirements of the Machinery, EMC and RoHS Directives should be allowed access to public roads. National technical regulations should not be a barrier. Also, the request covers self-balancing vehicles without a steering wheel. LEVA-EU is awaiting an official response from the Dutch government. In the meantime, it will inform the European Commission of their request.

Source: Annick Roetynck, LEVA-EU

Link to the request [HERE]

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The European Chemicals Agency has launched a new online database called “SCIP”, which stands for “Substances of Concern In articles as such or in complex objects (Products)”. SCIP is the database for information on substances of concern in articles as such or in complex objects (products), established under the Waste Framework Directive (2008/98/EC).

The public has been given access as of September 14, 2021 (see here). We believe that companies manufacturing and importing products into the EU should be aware of the SCIP database, as it will now be much easier for consumers, NGOs and the media to access information on products containing hazardous chemicals.

The SCIP database:

• aims to ensure that information on substances of very high concern (SVHCs) on the candidate list is available throughout the life cycle of products and materials, including in the waste phase;
• encourages the replacement of these hazardous substances with safer alternatives in the production of articles; and
• contributes to a better circular economy by helping waste managers ensure that such hazardous substances are not present in recycled materials.

Here you can find:

• articles containing a substance of very high concern (SVHC) listed in the candidate list at a concentration greater than 0.1 percent by weight (w/w); or
• complex articles (products) incorporating such articles that have been placed on the EU market.

SCIP is aimed at consumers. The idea is that easy access to information will help them make better informed choices and encourage companies to replace hazardous chemicals.

The information stored in the SCIP database is collected under EU waste regulations. Since January 5, 2021, companies are required to declare certain products manufactured or imported into the EU that contain chemicals designated as “substances of very high concern” in concentrations greater than 0.1 percent by weight. These declarations are then stored in the SCIP. Currently, the database contains more than 12 million entries.

• You can find SCIP here
• The current database (23rd of September 2021) already contains 4,690,790 results!

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A causal Bayesian network approach to consumer product safety and risk assessment. Bayesian statistics is a modern branch of statistics based on Bayesian probability, one of the interpretations of probability. In it, probabilities are constantly revised based on new information that has become available.

This independent report was prepared by Queen Mary University London on behalf of the Office for Product Safety and Standards. It outlines the limitations of the risk assessment approach for Safety Gate – formerly RAPEX – the EU’s rapid alert system for dangerous non-food products. An improved methodology based on causal Bayesian networks is proposed.

This is a report for the Office for Product Safety and Standards (OPSS) by Joshua Hunte, Martin Neil and Norman Fenton of Queen Mary University London.

The views expressed in this report are those of the authors and not necessarily those of the Office for Product Safety and Standards or the Department for Business, Energy & Industrial Strategy (nor do they reflect government policy).

A summary of the report can be read here

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The Office for Product Safety & Standards (OPSS) recently published the results of an experimental study of the rebound effects of using unequal punishment. Under what circumstances can penalties have unintended backfire effects?

It is a report by Christoph Kogler and Marcel Zeelenberg of Tilburg University, Jerome Olsen of the Max Planck Institute, University of Bonn, and Magda Osman of the Judge Business School, University of Cambridge. The views expressed in this report are those of the authors and not necessarily those of the Office for Product Safety and Standards or the Department for Business, Energy & Industrial Strategy (nor do they reflect government policy).

The effects of financial incentives and penalties are highlighted through varying factors in relevant situations.

The report can be read [here]

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The Office for Product Safety & Standards (OPSS) recently published the results of an experimental study on the public perception of smart products. What do consumers think of the risks of smart products?

It is a report by Christos Bechlivanidis and Yanna Zhu of University College London and by Magda Osman, Centre for Science and Policy, Judge Business School, University of Cambridge.

• how consumers perceive the risks of smart products;
• how they assign blame when these products fail and cause harm;
• what actions consumers are willing to take in response.

It is based on online experiments with 1850 UK participants. The views expressed in this report are those of the authors and not necessarily those of the Office for Product Safety and Standards or the Department for Business, Energy & Industrial Strategy (nor do they reflect government policy).

Smart products; consumer perspective A summary of the report can be read here

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Proposed EU legislation establishing new rules for sustainable products is expected to be released in December. The Commission has three linked legislative proposals on sustainability on its agenda, which will be published in December 2021. The measures will affect the design, labeling, and marketing of a wide range of consumer products sold in the EU.

The proposals cover:

1. the sustainable products initiative, which aims to reduce the use of hazardous chemicals and make products placed on the EU market more sustainable, durable, reusable, repairable, recyclable and energy efficient;
2. Strengthening consumers' roles in the green transition – a consumer law initiative aimed at assisting consumers in making informed decisions based on reliable and relevant information about product sustainability and protecting consumers from certain unsustainable commercial practices; and
3. substantiating green claims – which strives to standardize the methods organizations deploy to validate claims about their products and services' environmental effects.

We will continue to monitor the developments, and to keep you informed.

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People are being encouraged to contribute their views on changes to how medical devices will be regulated across the UK.

From:
Medicines and Healthcare products Regulatory Agency and The Rt Hon Sajid Javid MP
Published
16 September 2021

Launched today by the Medicines and Healthcare products Regulatory Agency (MHRA), the 10-week consultation gives everyone the opportunity to draw on their own experiences and contribute to the improvement of the regulatory framework and therefore patient safety in the future.

From hearing aids and walking sticks, to insulin pumps and thermometers, for many of us, medical devices are an essential part of our everyday lives. We all want to know that the devices we use are safe and effective, so regulation of medical devices really matters, especially where fast-developing technology has changed, and continues to influence, the landscape for medical devices, bringing new, innovative devices to the UK market, including some health apps.

The MHRA is the regulator for medical devices used in the UK. We are seeking views from across the medical devices and healthcare sectors, medical practitioners, patients and the wider public, to inform our future approach. We would like to hear from those who research, manufacture, supply and use medical devices.

Medical devices in the UK are currently regulated under the Medical Devices Regulations 2002. Following the UK’s departure from the European Union, the MHRA now has the opportunity to create a world-leading regime that prioritises patient safety while fostering innovation, including streamlining the approval of medical devices.

This consultation is comprehensive – covering a broad range of regulatory issues – from requirements for running clinical investigations, to how devices are assessed before being placed on the market through to importer and distributor obligations and post-market surveillance to transparency and the role of patients. It provides a once in a generation opportunity to ensure the safety and quality of medical devices that many of us rely on, and from which we all benefit.

Dr June Raine, Chief Executive of the MHRA, says:

The launch of this consultation is an exciting step towards a more robust, world-leading regulatory framework for medical devices in the UK, one that enhances medical device safety and quality, access to devices, and has patients at its heart.

We know that a problem with a medical device can have a significant impact on people’s lives. This consultation offers a once in lifetime chance to help shape the regulations. In order to reach this goal, we want to hear from a wide range of people. Delivering for patients is central to our work and we fully recognise the importance of the public and patients’ perspectives and encourage them to share their views during this consultation.

This is your chance to make a difference to people’s experiences with devices by helping shape the regulations around medical devices – from how much scrutiny they face before they reach the market, to how they are tracked and monitored, and what actions are taken if problems with a device arise. It is also an opportunity to impact what products the MHRA regulates – for example, should the MHRA have a role in the regulation of other products which are similar to medical devices such as cosmetic coloured lenses or dermal fillers?

We encourage everyone to share their views on the future of medical devices regulation through this public consultation.

Health and Social Care Secretary Sajid Javid said:

The UK is home to one of the world’s most renowned regulators, ensuring the safety and effectiveness of the medicines and medical devices that we all rely on.

This consultation will allow us to revolutionise the regulation of medical devices, making sure our pioneering life sciences sector can continue to lead the world and safeguard the health of our nation.

From pacemakers to contact lenses, wheelchairs to pregnancy tests, medical devices play a vital role for the vast majority of us and I encourage everyone who wants to be a part of this mission to put forward their views.

The consultation will close at 11.45pm on 25 November 2021.

Over the coming months, we will be running a number of webinars giving more information about the background to and scope of this consultation and how to respond. Please see our Eventbrite page for the webinars aimed at industry, and one aimed at patients and public.

MHRA seeks consultation MDR

Notes to editors

• The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK.
• The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health and Social Care.
• This consultation is on a future UK-wide scheme for regulating medical devices. It recognises the Government is seeking a new balance to the Northern Ireland Protocol to place it on a more sustainable footing as expanded on in its Command Paper – Northern Ireland Protocol: The way forward.
• Under the current approach to the Northern Ireland Protocol, EU rules on medical devices continue to apply in Northern Ireland. The EU Medical Devices Regulation (2017/745) (EU MDR) therefore took effect in Northern Ireland on 26 May 2021 and the in vitro Diagnostic Medical Devices Regulation (2017/746) (EU IVDR) will take effect from 26 May 2022. The EU MDR and EU IVDR will not apply in Great Britain. We welcome views on alignment across all of the UK nations as part of this consultation. The Government is also seeking a new balance to the Protocol and, as set out in its Command Paper, has proposed a dual regulatory regime in Northern Ireland where goods that meet either UK or EU rules could circulate within Northern Ireland.

Published 16 September 2021

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The European Commission is collecting comments on a proposed change to the EU’s chemical classification law, which would be a significant step toward a far bigger overhaul of the EU’s chemical framework.

The European Commission is seeking feedback on the Regulation on classification, labelling, and packaging of substances and mixtures (“CLP”), which is one of the most important pieces of EU chemical legislation. Here’s a quick rundown of the CLP, why it’s being updated, and why it matters to businesses.

A public consultation on policy proposals for reforming the CLP has been launched by the European Commission. By November 15, 2021, any individual, company, or association can submit comments to the Commission, which will be published on the Commission’s website. This consultation is part of a much bigger revision of EU chemical legislation. Reforming the REACH Regulation and other product-specific standards, such as those on cosmetics and food contact materials, as well as introducing new technologies like e-labelling, are all part of the makeover. The EU chemicals system is considered as no longer fit for purpose, with global chemicals production predicted to quadruple by 2030 and chemicals used in 96 percent of produced goods, resulting in a demand for evaluation and probable reform.

What is the CLP?

The CLP is the foundation of EU chemical legislation. It instructs businesses on how to define dangerous substances and how to communicate this information through labeling, packaging, and information sheets. Companies that operate at all stages of the supply chain, including those who employ chemicals in their products, should be aware of the CLP.

Many other pieces of EU law, particularly Regulation 1907/2006 on the Registration, Evaluation, Authorization, and Restriction of Chemicals (“REACH”), will be affected by changes to the CLP (here). Companies must register their compounds under REACH, and substances might be prohibited based on their assessed danger. The classification of the substance, which is done based on the criteria set out in the CLP, is an important aspect of REACH registration.

Why does the CLP need a reform?

The CLP reform is part of the European Commission’s extremely ambitious “Chemicals Strategy for Sustainability”, which was launched in October 2020. More than 50 steps in the strategy will necessitate legislative amendments.

The CLP is no longer considered fit for use. Why? One of the most heard opinions is that the current laws are excessively ambiguous about who is legally accountable for compliance, which might cause problems in complex supply chains or with online sales. This makes it difficult for firms to comprehend and comply with the CLP’s requirements. The Commission has acknowledged this, as well as its belief that the CLP no longer encompasses the whole range of chemical dangers.

Is the public consultation important for the industry?

Companies who manufacture, export, or use chemicals in their products should consider contributing to the consultation, or at the very least staying close to the outcome. The Commission has released an Inception Impact Assessment, which outlines many policy options under consideration. Some of these policy alternatives, particularly those targeted at making compliance easier, are likely to be beneficial to businesses.

The Commission, for example, has stated that it intends to allow corporations to put multilingual fold-out labels on normal-sized packages, which is presently illegal.

However, if some of the proposals are implemented, they may create new challenges that would have a substantial influence on global businesses. The present CLP is based on UN standards that are universally harmonised. If the EU departs from these principles, there may be separate restrictions for chemical and mixture exports to EU and non-EU nations.

The Commission has also proposed creating new danger classes that do not already exist, such as endocrine disruptors, which have long been a source of debate in Europe. The goal of establishing a new hazard class under the CLP is to “avoid the use of endocrine disruptors in consumer products” in the long run. This might have a big impact on enterprises who make and import consumer goods, because ingredients that are currently allowed in the EU could be prohibited in the future.

CLP Reform; EU Seeks Input, source: Emma Bichet and Claire Temple

• CLP – The Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008)
• Have your say at: Revision of EU legislation on hazard classification, labelling and packaging of chemicals
• E-labelling: Chemicals – simplification and digitalisation of labelling requirements
• REACH
• Chemicals Strategy for Sustainability
• Inception Impact Assessment

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Itoro Udofia, director, Medical Health Service at TÜV SÜD, a global product testing and certification organisation, explains what you need to know about the UKCA mark.

UKCA marking (UK Conformity Assessed marking) is the UK product marking requirement that is now required for any product being placed on the market in Great Britain (GB) – England, Scotland, Wales, substituting the European Union’s (EU) requirements for CE marking. As from 1 July 2023, it will be mandatory for every medical device, to display the UKCA marking.

For medical devices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance on how medical devices are now being regulated. As of 1 January 2021, medical devices being placed on the market in the UK must follow new legislation – the Medical Devices Regulations 2002 (SI 2002 No 618, as amended).

While all medical devices, in vitro diagnostic devices (IVD), and custom-made devices must be registered with the MHRA as from 1 January 2021, depending on the classification of a product there is a grace period according to the device type and its classification. While it is possible to register devices ahead of the dates below, there is no legal obligation to do so:

From 1 May 2021:

• Active implantable medical devices
• Class III medical devices
• Class IIb implantable medical devices
• IVD List A products

From 1 September 2021:

• Class IIb non-implantable medical devices
• Class IIa medical devices
• IVD List B products
• self-test IVDs

From 1 January 2022 (Note: in Northern Ireland, these products must be registered by 1 January 2021):

• Class I medical devices
• general IVDs

Any medical devices that were previously registered with the MHRA before 1 January 2021, do not require re-registration.

Where third-party conformity assessment is required, a UK Approved Body is needed. However, Class I device and general IVD manufacturers can self-certify against the UKCA mark. It is important to note that the exception to the rule is Class I medical devices that are sterile or have a measuring function, as they require approval from a UK Approved Body.

If the manufacturer is located outside the UK, they must appoint a UK Responsible Person (UKRP), who must be based in the UK. The UKRP then acts on behalf of the outside-UK manufacturer to ensure that their obligations are carried out, and it is permitted for an importer or distributor to act as a UKRP. In all instances, where the UKCA mark has been affixed, the name and address of the UKRP must be included on product labelling.

Under the NI Protocol, the CE mark is still required in NI. So, even after 30 June 2023 CE marked medical devices can continue to be placed on the market. Under these rules, qualifying goods are those in free circulation in NI – not those under a customs procedure or in an authorised temporary storage facility before being moved between NI and GB.

If a UK body carries out a mandatory third-party conformity assessment, then a UKNI marking must be applied – but must be accompanied by EU conformity marking (e.g. CE marking). Goods with both the CE and UKNI marking cannot be placed on the rest of the EU market. If a mandatory third-party conformity assessment was carried out by an EU-recognised notified body, goods with the CE marking can be placed on NI and EU markets.

As a deviation from the GB requirements, the Medical Device Regulations, 2017/745(EU MDR) and the In Vitro Diagnostic Medical Device Regulations, 2017/746(EU IVDR) apply in NI from 26 May 2021 and 26 May 2022, respectively. This means that GB manufacturers will require an EU Authorised Representative, located either in NI or the EU, to place products in the NI market.

The changes being made to accommodate UKCA marking requirements necessitate a new approach and it is imperative to register products with the MHRA as soon as possible. To register with the MHRA you must show evidence that your medical device has undergone conformity assessment by a UK Approved Body, which must be based in the UK. Following approval from a UK Approved Body, the manufacturer will be able to affix the UKCA mark (in Great Britain), or UK(NI) mark (in Northern Ireland). Alternatively, if your products are CE marked, then you may also use your CE certificate as evidence to register with MHRA until 30 June 2023.

Source: Med-Tech News – Itoro Udofia (UKCA mark: The practicalities)

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The French-owned sporting goods store Decathlon has been fined in Australia for selling products without sufficient safety warnings. The store discovered to its cost (it was fined A$1.5m) that using European regulations to assure compliance with a different continent did not work. This isn’t the first time a corporation has gone down this path. Companies from Europe frequently believe that if their product meets EU requirements, it must also meet US or Australian requirements.

Decathlon has outlets in Sydney and Melbourne. Between 2016 and 2019 it supplied multiple versions of basketball rings and pools that lacked the necessary safety labeling, consumer warnings, and instructions. Last July, the Australian Competition and Consumer Commission (ACCC), a federal watchdog, began looking into the situation.

Decathlon has admitted to supplying 432 basketball rings and backboards. It also sold 307 portable swimming pools that do not meet safety regulations.

Portable Swimming Pools

There were 66 portable pools that lacked essential warnings. For example “Children have drowned in portable swimming pools” and “Ensure active adult supervision at all times” should have been used.

Basketball Rings And Backboards

Decathlon also sold 341 basketball rings and backboards without warnings that they should not be attached to brick walls.

“Mandatory safety standards exist to reduce the risk of death and serious injury to consumers, especially children, when using these types of products”, ACCC deputy chair Delia Rickard declared.

Furthermore she said: “By not including these important warnings, Decathlon put consumers at risk of serious harm when they were using the Decathlon swimming pools, basketball rings and backboards. It is illegal to sell products in Australia that do not comply with mandatory safety standards, and consumers have a right to expect that products they purchase will not endanger their safety or the safety of their family and others.”

Decathlon must also post a remedial notice on its website. Furthermore it must create an Australian Consumer Law (ACL) compliance program in addition to the penalties. The merchant has agreed to abide by all court orders and pay the ACCC’s expenses.

Decathlon maintains five locations in Melbourne and Sydney, as well as a digital portal. Over 1,500 stores are currently open in over 55 countries. Its headquarters are in France.

Source: The Retail Insight Network

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Mr Antony Hayes has a long history in Quality Assurance. He managed multinational companies and had overall responsibilities of Divisions’ development and strategy including FSC licence; improving the efficiency, processes and competence. Mister Hayes is also the author of ‘The Future of Quality’; a look at where quality processes and practice should be heading.

“The book aims to put forward some very obvious changes that are already occurring and some that may be less obvious that technology will make possible. The future is good but the current manpower levels in some large companies related to managing quality of product, production, processes and services are going to change.”

The Livestream starts a few minutes before 3PM CET (2PM GMT, 9AM EST and 6AM PST) and can be watched on YouTube and Facebook.

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On May 26, 2021, the Medical Devices Regulation (MDR) became completely applicable throughout the EU. It is a much-anticipated strengthening of Europe’s existing medical device regulatory framework, and it imposes important new requirements on economic operators throughout the medical device supply chain.

What are the MDR’s current registration requirements?

EUDAMED

Article 33 of the MDR mandated the construction of a European medical device database (EUDAMED). This database intends to improve information flow between economic operators, notified organizations, clinical trial sponsors, and member states, as well as inform the general public about products on the market.

Six interrelated modules make up the portal’s structure:

1. Registration of actors (currently operational);
2. Registration of UDIs and Devices (available September 2021);
3. Certificates and Notified Bodies (available September 2021);
4. Clinical trials and performance evaluations;
5. Post-market surveillance and vigilance;
6. Market Observation.

Actor Registration

Economic operators from across the supply chain (EU and non-EU manufacturers, authorised representatives, system/procedure pack producers, and importers) can use the EUDAMED platform to submit registration requests.

These requests must then be validated by their national responsible authority. Following the national competent authority’s assessment and approval of the request, EUDAMED issues a Single Registration Number (SRN) to the national competent authority and transfers it to the requesting economic operator.

For economic operators, the SRN ensures a unique identification across the EU. For each Actor role that an economic operator undertakes, it must obtain a different SRN.

Manufacturers based outside of the EU 27, Iceland, Liechtenstein, Norway, or Northern Ireland will be able to register only if their authorised representative is based within the EU 27, Iceland, Liechtenstein, Norway, or Northern Ireland, and the authorised representative verifies the registration request before submitting it to the national competent authority for assessment.

MDR Current Registration Requirements & Additional HPRA (Ireland) Registration Requirements

The Health Products Regulatory Authority (HPRA) in Ireland has published registration requirements additionally to EUDAMED.

1. The HPRA has produced a suite of guidelines on the registration requirements for medical devices since the MDR went into effect. In addition to the EUDAMED requirements, certain economic operators based in Ireland are required to register with the HPRA on a national level. Distributors and production facilities who want to evade EUDAMED’s registration requirements must register with the HPRA instead. Similarly, health institutions in Ireland that manufacture medical equipment, such as hospitals or clinics, are required to register with the HPRA.

2. An operator must register with HPRA as a custom-made device manufacturer if it makes custom-made devices (classes I, IIa, and IIb of the MDR classification). In contrast, if a company makes custom-made class III or implantable medical devices, it must register with EUDAMED.

Device Registration

– Regarding the registration of devices, the HPRA has requested that, in the absence of the EUDAMED module for registration, details for any MDR / IVDR compliant class I devices, system and procedure packs, custom-made devices and in-vitro diagnostic devices should be submitted to the HPRA using the relevant MDR Spreadsheet or IVDR Spreadsheet

– There is also an MDR Legacy Spreadsheet that may be used to voluntarily register ‘legacy devices’ or MDR compliant devices that have been certified by a notified body. Legacy devices are medical devices covered by a valid certificate under the old Directives, which can continue to be placed on the market until 27 May 2024 and made available until 27 May 2025.

– The HPRA has advised that economic operators should ideally have an SRN issued by EUDAMED or a HPRA registration number before registering devices with it.

Separately, the HPRA has announced that it is working on a new medical device registration platform. All economic operator and device registration data will be transferred to the new portal once it is available. The HPRA’s ultimate goal is to create a machine-to-machine interface between this portal and EUDAMED. This guarantees that the records are identical and eliminates the need for duplicate data entering. The launch date for this portal has yet to be announced.

Required Actions

Despite the fact that the Actors registration module on EUDAMED is operational, economic operators should be aware that the MDR’s requirements for EUDAMED will not take effect until six months after the Commission has given notice under Article 34(3) that the database is fully operational.

As a result, while the technological infrastructure to enable Actors to register on EUDAMED is in place, registration is voluntary.

The deployment of a fully functional EUDAMED is expected to take place in the first half of 2023, according to the most recent estimates from the Commission, therefore the current scenario appears to be poised to continue. In the interim, the HPRA has indicated that “in the absence of a fully working EUDAMED,” it “recognizes the voluntary registration module of EUDAMED.”

Custom-made manufacturers, distributors, health institutions, and Irish manufacturing facilities, on the other hand, should take immediate action to comply with the HPRA registration requirements rather than EUDAMED.

Conclusion to MDR Current Registration Requirements

The environment for registering economic operators and medicinal devices under the MDR is currently in flux.

Despite the Commission’s declaration that a fully functional EUDAMED is a “high priority,” it appears that there is still a long way to go to achieve this goal.

Source: Mondaq

To help economic operators navigate the new systems, the Commission has prepared helpful guide sheets. These can be found here.

MDR Current Registration Requirements (EUDAMED) for the EU and additional registration requirements for the Republic of Ireland.

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Context

The New Legislative Framework (hereinafter referred to as NLF) for EU product legislation consisted of Decision No 768/2008/EC and Regulation (EC) No 765/2008. It aimed to improve the internal market for goods and increase the quality of conformity assessment of products. Decision No. 768/2008/EC was a model for future Union product legislation. More than 20 legal texts have been aligned with the Decision today (1).

Since the adoption of the Decision, industry and products have undergone a digital and green transformation. The NLF ensures that products comply with applicable legislation at the time they are placed on the market. Products are becoming increasingly digital and are often updated or upgraded after they are put into service. They may also contain artificial intelligence that will lead to further changes to the product.

Evaluation New Legislative Framework

Manufacturing products is an ever-growing industry. The goals of promoting the circular economy and ensuring product safety must be adequately addressed. In today's economic reality and changing digital environment, there is a need to reassess whether the NLF is still fit for purpose. Moreover, it should be considered whether the conformity assessment procedures are still fit for this changing environment. These are the procedures that ensure that products placed on the Union market comply with the applicable legislation.

Where an independent third party (so-called "notified bodies") is involved in the conformity assessment procedure, the competence of such a body must be ensured. To this end, the NLF describes the accreditation of notified bodies as the preferred means of demonstrating the competence of such bodies; accreditation can thus play an important role, but its use is not mandatory in the EU (2).

Moreover, the recent COVID-19 crisis has challenged the resilience of Union product legislation based on the provisions of the NLF. Particularly in terms of whether it can adequately deal with a crisis. When certain products that played a role in combating COVID-19 (notably personal protective equipment and medical devices) became scarce, the rapid market entry of new products proved challenging. Specifically, it involved becoming familiar with the legislation and standards and completing the conformity assessment procedures.

Purpose and scope

Evaluation New Legislative Framework assesses its effectiveness, efficiency and relevance. It considers:

• technological development,
• coherence with similar initiatives and
• the overall EU added value.

The main objective is to provide an informed analysis of the current performance of the NLF. The exception is the provisions of Regulation (EC) No 765/2008 related to market surveillance. This has already been subject to an evaluation and review (3).

This review covers 27 EU Member States and 3 EFTA countries (Norway, Iceland and Liechtenstein) and the period from 2014 to 2020 (4) .

In particular, the review should focus on whether:

i) the NLF is appropriate to address how products may change during their lifetime, both to support the introduction of smartly connected or remanufactured products and to ensure safety;

ii) the conformity assessment procedures remain fit for purpose and ensure the safety and compliance with applicable requirements of products placed on the Union market;

iii) the rules for notified bodies are sufficiently robust to ensure the competence of those bodies;

iv) the accreditation system functions properly and ensures that the competence of notified bodies involved in conformity assessment procedures is sufficiently guaranteed;

v) the affixing of the CE marking and other product information on the product itself is still adequate;

vi) the lack of a crisis instrument for urgent situations makes the NLF less effective or efficient.

Consultation of citizens and stakeholders

The consultation strategy will aim to be as representative as possible of the different product sectors, types of stakeholders and Member States.

The following categories of stakeholders will be consulted:

1. relevant Member State authorities (including market surveillance authorities and notifying authorities) and accreditation bodies,
2. individual companies that are manufacturers, including SMEs and industry associations,
3. other economic operators (such as distributors and importers),
4. notified bodies,
5. consumer organizations.

The following consultation activities will be conducted:

• public consultation to gather general evidence for the review. This will last for 16 weeks;
• targeted online survey to collect quantitative and qualitative data from different categories of stakeholders;
• interviews to gather information on the evaluation questions. Among others, on the different types of compliance and administrative costs and benefits. This is mainly in relation to the conformity assessment procedure.
• interviews to validate/test the evidence gathered and fill in the gaps so that there is a solid and credible basis to support the findings of the evaluation;

A validation workshop will be organized with key actors involved in the evaluation. The Commission will inform stakeholders about the start of the public consultation.

Data collection and methodology

The methodology for the evaluation includes.

• Desk research and literature review, including the previous evaluation for internal market legislation on industrial products (SWD(2014)23). Existing evaluations of specific product legislation based on the NLF are also included.
• REFIT review accompanying the proposal for a Regulation of the European Parliament and of the Council laying down rules and procedures (where relevant). This is for compliance and enforcement of Union harmonization legislation on products and annexes (SWD(2017)469).

The methodology for data analysis shall include at least:

• the analysis of the intervention logic,
• indicators to measure the direct and indirect effects of the NLF,
• triangulation of information,
• relevant statistics to support the analysis to identify the regulatory and administrative costs and benefits arising from the NLF. Data on the costs and benefits of the NLF will be collected through targeted surveys and interviews with stakeholders involved in the process;
• economic operators (manufacturers, importers, distributors),
• notified bodies involved in the conformity assessment procedure,
• market surveillance authorities,
• consumer organizations,
• case studies based on specific product categories, depending on the availability of data and the particularity of the product.

Evaluation New Legislative Framework

(1) See https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en

(2) EU product legislation is based on the fact that the manufacturer is responsible for the conformity of the product with the applicable legislation and must carry out the relevant conformity assessment procedure to demonstrate such conformity. Certain parts of the EU product legislation require that a third party conformity assessment body intervene in the conformity assessment procedure and perform certain tests on the product. Where this is the case, only the conformity assessment bodies designated for this purpose by the authorities of the Member States can perform the conformity assessment tasks required by that legislation. These are the so-called notified bodies. They must be notified to the Commission and the other Member States by public authorities in the Member State where these bodies are established. These notifying authorities are responsible for the competence and supervision of the notified bodies. In order to demonstrate their competence, notified bodies can provide an accreditation certificate issued by the national accreditation body, which declares that they are competent to perform the conformity assessment tasks specifically required by EU product legislation, according to Regulation (EC) No 765/2008.

(3) The market surveillance provisions of Regulation (EC) No 765/2008 were already the subject of a REFIT review (SWD(2017) 469 final). Since then, a new Regulation (EU) 2019/1020 will replace those provisions from July 2021.

(4) This review will build on and complement the SWD(2014)23 review (https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A52014SC0023&qid=1604000100861) to Commission Communication COM(2014)25 on "A vision for the internal market for industrial products" (https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=CELEX%3A52014DC0025&qid=1603999880951).

Additional information: https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en

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The freedom to chart its own course could lead to an end to irritating cookie popups and consent requests online, said the culture secretary, Oliver Dowden, as he called for rules based on “common sense, not box-ticking”.

But any changes will be constrained by the need to offer a new regime that the EU deems adequate, otherwise data transfers between the UK and EU could be frozen.

A new information commissioner will be put in charge of overseeing the transformation. John Edwards, currently the privacy commissioner of New Zealand, has been named as the government’s preferred candidate to replace Elizabeth Denham, whose term in office will end on 31 October after a three-month extension.

Dowden said: “Now that we have left the EU I’m determined to seize the opportunity by developing a world-leading data policy that will deliver a Brexit dividend for individuals and businesses across the UK.

“It means reforming our own data laws so that they’re based on common sense, not box-ticking. And it means having the leadership in place at the Information Commissioner’s Office to pursue a new era of data-driven growth and innovation. John Edwards’ vast experience makes him the ideal candidate to ensure data is used responsibly to achieve those goals.”

The GDPR data protection rules introduced by the EU in May 2018 are part of UK law even after Brexit, under the Data Protection Act.

The regulation imposes strict restrictions on what data controllers can do with individuals’ personal data. It has been criticised by many for its over-reliance on consent-based permissions, which some argue has led to a boom in box-ticking but little meaningful protection of citizens.

The government hopes to prioritise “innovative and responsible uses of data”, a spokesperson said, so that it can “boost growth, especially for startups and small firms, speed up scientific discoveries and improve public services.”

Any future data regulation will also be aimed at convincing other nations that the UK’s data protection is adequate by their own standards, to allow for free and easy transfer of information across international borders. The government announced six target nations for such adequacy agreements, including the US, South Korea and Australia.

Eduardo Ustaran, a co-head of the global privacy and cybersecurity practice at the law firm Hogan Lovells, said Edwards’ appointment boded well for the government’s plans.

“The UK is starting to show that there is room for diversion from EU data protection law whilst still retaining the GDPR as a framework. What this means in practice is that the way in which international data flows are approached is not identical to the way the same data flows are treated in the EU, but this doesn’t necessarily mean that the protection is going away,” Ustaran said.

“What the UK government is testing is our ability to recognise that the protection of personal data around the world comes in different shapes and forms, but can still be effective. The appointment of John Edwards as the next information commissioner is a vote for no-nonsense and pragmatism for the future of data protection regulation.”

Source: The Guardian

Topics

• GDPR
• Data protection
• Data and computer security
• Brexit
• news

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The RHC describes the report as a "timely call to action" for the UK to address how it can foster investment and innovation in medical devices while both increasing safety and charting a path forward after Brexit. The Report is placed against a backdrop of events that, according to the RHC, represent unique challenges for the life sciences industry to address, including:

• Brexit and the fact the EU has adopted new medical device regulations, whereas UK regulations are two decades old;
• The Independent Medicines and Medical Devices Safety Review, published last year by Baroness Cumberlege that contained significant criticism of the existing regulatory regime; and
• The power at the government’s disposal to introduce secondary legislation under the Medicines and Medical Devices Act 2021.

The RHC is a non-governmental organization, and its recommendations do not represent UK government policy. However, Kwasi Kwarteng, the Secretary of State for Business, Energy and Industrial Strategy (BEIS), has praised the report, calling it "very relevant and topical." The findings of the report will have an impact on the government's intentions to alter medical device rules. Anyone who works in the medical device industry and is responsible for risk management or insurance is encouraged to study the Report.

These are three of the recommendations made in the report:

1. Centre the regulation of medical devices on the needs of patients
2. Build international partnerships through mutual recognition of other jurisdictions’ regulations
3. Develop a UK patient safety database

1. Centre the regulation of medical devices on the needs of patients

Before products are put on the market, the RHC is pressing for patient representation on expert panels. Existing patient consultation activities should also be expanded, according to the report. When seeking regulatory approval, manufacturers would have to reconsider how they present the balance of risks and benefits to patients. They'd also need to get better input from patients in clinical trials.

While these steps may raise prices, they may also make devices more resistant to product liability lawsuits when patients experience side effects. Before a product is released, the tough topic of how much risk is acceptable will have been discussed with patients. When the court evaluates whether or not a product is defective, this information will be useful. Furthermore, patient groups may demand improved risk explanations or additional safety precautions, resulting in goods that are safer and less likely to be sued.

2. Build international partnerships through mutual recognition of other jurisdictions’ regulations

What was Brexit for? That is the one component of medical device regulation that is most likely to become a political hot potato. The Prime Minister emphasized that Brexit was about sovereignty and the UK regaining control of its laws in the run-up to the conclusion of the "Brexit Deal" (the Trade and Cooperation Agreement of December 2020).

Because UK firms will have to comply with EU standards to sell products there, the bio sciences industry has been skeptical that there will be much of a "sovereignty dividend" from Brexit. Similarly, European manufacturers will be more willing to invest in the UK if the UK adopts standards that are broadly similar to their own. The RHC acknowledges this, stating that “international initiatives to strengthen regulatory collaboration and decrease potential trade barriers” are needed. By recognizing this problem, the Report echoes the concerns raised by industry and regulators, alluding to a clear caution to the government not to stray too far from international standards.

Patient safety is also a consideration. The government should consider adopting the patient safety provisions in the EU's new Medical Device Regulation 2017/745, according to Baroness Cumberlege's report.

The report indicates that future UK laws will be largely equivalent to EU requirements.

3. Develop a UK patient safety database

The Medicines and Healthcare Products Regulatory Agency (MHRA) and the National Health Service (NHS) both maintain data programs, according to the RHC. It proposes a unified reporting mechanism for adverse events, which would be stored in an MHRA database. If this comes to fulfilment, it will help to address Baroness Cumberlege's concern that regulators and manufacturers have taken too long to notice trends when a product is underperforming.

This approach will be welcomed by manufacturers and their insurers. Better data could lead to better systems, allowing manufacturers to provide clinicians with more timely advise or potentially recall items early.

Conclusion

Since February, the Medicines and Medical Devices Act 2021 has been on the books, giving the government the authority to create a new medical device regulatory framework. The business community is waiting to see what the government will do next.

The report adds to the pressure on the government, which has been exerted by Baroness Cumberlege and others, to develop a framework that encourages innovation while also paying more attention to patient safety without departing too far from EU laws.

Source: RHC Report on Medical Devices published on 19 August 2021

UK Medical Devices Regulatory Needs Reform

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This measure has been taken to grant the industry additional time to make the transition. The extension applies provided that the UK and EU product requirements are the same. The rule also includes products which have been assessed by an EU recognised notified body. Those companies that already want to affix the UKCA marking are free to do so, provided of course that their products comply with the applicable UK regulations.

We continue to continue to monitor the regulatory developments in the UK and in the EU.

Details: UK Government Website

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Artificial intelligence is evolving at a rapid pace. Therefore, it is challenging current regulations on medicines and medical devices. This is evident from a global inventory by the ICMRA (International Coalition of Medicines Regulatory Authorities. This international consortium of regulators wrote a report on the subject. and conclude that a permanent AI-working group is needed. The recommendation is to appoint a permanent working group. This will have to keep a sharp eye on the regulation of AI as it is developed and assessed.

On August 6, 2021, ICMRA released a report. This describes the results of two field studies. These should serve as stress tests for member agencies. The authors emphasize the need to bring in ethical experts. After all, the pharmaceutical industry is making greater use of AI. Also, a regulatory framework for AI will be needed. This should take into account factors such as the validity and origin of data. Furthermore, the framework should also consider the reliability and transparency of AI algorithms. For this, a permanent AI-working group is needed.

Ad Hoc Working Group Say That A Permanent AI-Working Group Is Needed

For this purpose, an informal network for innovation was previously formed. This consists of international regulators who are members of ICMRA. It has delegates from the EMA and WHO. Other members are from Italy, Denmark, Canada, Ireland and Switzerland. The FDA is also in the network although they have observer status.

A summary of the report says that there are opportunities to apply AI at each stage of the drug life cycle. This could be in target validation and biomarker identification. But also in the annotation and analysis of clinical data. For example in trials, pharmacovigilance and optimization of clinical use.

Hypothetical Case Studies

There is a lack of transparency in the algorithms underlying AI. This is especially true when machine learning techniques are used. Therein lies a significant challenge for the entire scale of AI applications. For example, machine learning can create a situation that has the potential to create clinical and regulatory conflicts. For example, a situation where the exact processes by which results are produced are no longer directly observable. This is a so-called “black box situation”.

The working group developed two imaginary situations:

1. An app designed to capture data related to the central nervous system;

2. The use of AI in monitoring drug use.

The Ad Hoc working Group claims that a permanent AI-working group is needed.

Data Capturing App Related To Central Nervous System

This imaginary app could serve as an aid in the selection of patients for participation in clinical trials. For example, one could record and analyze the baseline status of a disease in prospective participants. Also, this app could record a number of other things:

• adherence to trial interventions;
• the response to therapies;
• endpoints identified as changes in disease status.

This field-study highlights the importance of early advice from regulators during the product development process. In doing so, the report points to the considerable complexity and novelty of the research. The process will need to involve not only regulators in the medical device field. Academically trained experts are also likely to be part of the process. Because in addition to ethical and legal considerations, there is also a scientific aspect. These are weighed against regulatory decisions.

Black Box Important Reason Of Why A Permanent AI-Working Group Is Needed.

The assessment about meeting a full set of requirements poses considerable challenges for such a complicated product. In this perception, the working group identifies the problem of the “black box”. In it are the algorithms and the training and validation datasets used for AI development. Even if regulators are given access to it, full validation may not be possible. The report’s authors write that more sophisticated approaches may be needed. Such as, for example, examining the behavior of machines.

Apps need to be updated. Then bridging or validation studies may reveal a change in the benefit-risk profile of product. Subsequently, this may then lead to the need for additional regulations. It is the job of developers to carry out this task. In an ideal situation, developers have robust governance systems. These should oversee AI algorithms as they evolve through use.

App With AI Monitoring The Use Of Medicine

In the report, the study group states that AI systems seem to be suitable in principle for safety signal detection. Now, there is often still a lot of reliance on the manual component when using the tools for signal detection. To reduce this, an app like the one in the second study is very promising. A permanent AI-working group is needed to oversee the possibilities and restrictions.

When AI starts playing a more prominent role in this, the challenge lies in finding a balance between human supervision and AI. Continually, there needs to be a calculation of the benefits and risks with each therapy. AI has the ability to scan very large data sets and aggregate disparate information. This is promising for discovering security signals that may be missed with current methods. We can think of:

• drug-disease interactions;
• secondary malignancies;
• misuse of drugs;
• changes in patterns of drug use and side effects.

Pharmacovigilance

The MAH (Marketing Authorization Holder) should ensure that both AI experts and data quality and signal detection specialists work in pharmacovigilance. There may also be a third party involved in managing the AI component of the pharmacovigilance program. That will then have to assure the licensee and regulators that they will maintain and update the AI as necessary. They will also need to provide regulators with appropriate access to the AI tool.

Conclusion

The report outlines current AI activities and future strategies for various regulators. They are:

• Health Canada;
• Japan’s Pharmaceutical and Medical Devices Agency (PMDA);
• the EU’s European Medicines Agency;
• the relevant agencies of the European Commission, Swissmedic and the Therapeutic Goods Administration (TGA) of Australia.

They have a number of common points, including recognition of the potential of AI to contribute to pharmacoeconomic developments. They also want the work of regulators to be eased. However, it is imperative that regulatory science keeps abreast of the rapid developments in AI. There is also a need for a robust ethical framework.

Reference: Kari Oakes

Source: The Regulatory Affairs Professionals Society

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In-house Handling Of Customer Satisfaction

Amazon declared on Tuesday 10th of August 2021 that it will handle customer compensation for injuries in-house. If third parties are unresponsive or unable to reimburse legitimate claims, the company will pursue those companies. The changes, according to Amazon, will take effect on September 1st for all products sold on its website.

Customers can contact Amazon customer service, who will alert the vendor to the issue. If the seller does not reply Amazon says it will “address the immediate customer concern. We will bear the cost ourselves, and separately pursue the seller.” If the seller rejects the allegation, Amazon said it may intervene to help solve the problem by paying up to $1,000 to the customer.

As a result “This streamlined process will save time, money, and effort. Both for customers and sellers.” This is what Amazon said about its new “A-to-Z Guarantee.” Because Amazon revises its return policy, there is a change from the usual method. That requires purchasers to contact sellers directly about complaints.

Liability Issue

Several goods sold on Amazon have angered customers. In recent years, Amazon was already hit with numerous product-liability claims. They were from consumers who have been damaged by products sold on its marketplace by third-party vendors. Hoverboards, carbon monoxide detectors and also faulty dog collars sold on Amazon have all caused issues. These are just a few examples and now Amazon revises its return policy to deal with this problem.

This has prompted a lawsuit, “Oberdorf v. Amazon” in which the e-commerce giant is being sued for damages caused by goods supplied by third parties. The question is whether or not Amazon can be held liable. Amazon said it’s not a seller but just a marketplace for other sellers.

Also, last month, the US Consumer Product Safety Commission sued Amazon. The CSPC is seeking a court ruling that the giant is accountable for products sold by its vendors. As a result, they think that Amazon must cooperate with the agency’s obligatory recalls.

According to its conditions of use: “If you purchase any of the products or services offered by these businesses or individuals, you are purchasing directly from those third parties, not from Amazon”. Furthermore, it says: “Amazon does not assume any responsibility or liability for the actions, product, and content of all these and any other third parties.”

Amazon Revises Return Policy

The e-commerce colossal is now taking on part of that risk in order to keep some customers happy and protect businesses from paying out on false claims.

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European Union Harmonized Standards For Medical Devices: the Medical Device Coordination Group (MDCG) of the European Commission has issued new recommendations on the role of standards in the medical device industry (the Guidance). The Guidance explains how harmonised European standards (hENs) are governed. It also explaines the advantages of adopting hENs to demonstrate conformity with the key requirements of EU medical device regulation. In addition, the Guidance covers the idea of 'state of the art' which must be considered under EU medical device regulation. This is to ensure compliance with particular health, safety, and performance requirements.

The present EU medical device legislative framework is founded on the principles of the 'New Approach' and the 'New Legislative Framework'. They outline the basic health and safety requirements that must be completed before medical devices can be placed on the EU market. The Guidance indicates that hENs serve a critical role in offering technical solutions in support of those key needs for which the legislation is otherwise silent on how they should be accomplished. According to the Guidance, hENs include a ‘Annex Z' . That lists the applicable legal requirements covered by the standard for each item of EU legislation to which they may demonstrate conformance.

EU Procedure For Submitting Standardisation Requests For Medical Devices

The Guidance explains the procedure used by the European Commission for submitting standardisation requests for medical devices to the relevant European Standardisation Organisations, namely CEN and CENELEC. The standardisation requests concern the creation of specific standards that regulate technological solutions in support of the applicable legislation's basic requirements.

As a result, medical devices that are manufactured and developed in accordance with the applicable hENs are presumed to comply with the necessary essential legal requirements. Despite the obvious benefits of the presumption of conformance, reliance on standards in the medical device industry is still discretionary, as is the intent of standardisation as set out in the Regulation on European Standardisation 1025/2012: “The primary objective of standardisation is the definition of voluntary technical or quality specifications with which current or future products, production processes or services may comply.”

In practice, a manufacturer can demonstrate conformity by using hENs' technical solutions, non-harmonised European standards, or other international or national standards. A manufacturer may also choose to develop its own technical solutions, provided that it can demonstrate that the alternative non-harmonised means comply with the legal requirements that apply to the product.

Exceptions

However, there are a few key exceptions to the idea of voluntary compliance with standards for the symbols and identification colors used to communicate mandatory, regulated information to end users. The necessary hENs as indicated in the Annexes of the applicable EU medical device legislation must be followed.

The Concept Of 'State Of The Art'

The Guidance also offers helpful insights into the concept of ‘state of the art,' which must be considered when demonstrating a product's compliance with specific health, safety, and performance requirements as set down in applicable EU medical device legislation. Because it is a complicated concept with no actual legal status, the Guidance cautions that conforming to the most recent version of a standard not listed in the Official Journal of the EU does not automatically imply compliance with the requirements of the applicable EU legislation if no additional evidence is provided in the product's technical documentation.

Conclusion

European Union Harmonized Standards For Medical Devices. With the MDR's recent implementation, this MDCG Guidance serves as a timely reminder of how harmonised EU standards can assist producers in meeting the essential health, safety, and performance requirements outlined in applicable EU legislation. Medical device manufacturers are advised to adopt the latest versions of the hENS into their compliance programs to ensure continuing compliance with the appropriate essential regulatory requirements outlined in the applicable EU medical device law.

The different standardisation mandates provided by the Commission to CEN and Cenelec in respect to the old Directives expire with those pieces of legislation, as indicated in the Guidance. The European Commission recently requested that CEN and Cenelec adopt and list standards that will be recognized under the MDR and the IVDR. The first of these harmonised standards have now been published in the Official Journal of the European Union in respect of the MDR on 19 July 2021 (OJ L 256, 19.7.2021, p. 100) and the IVDR on 20 July (OJ L 258, 20.7.2021, p. 50). The publication of these and further harmonised standards is something that manufacturers should continue to monitor closely.

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– Safety & surveillance; digital therapeutics pose challenges in the demand for accountability and effective regulation. Especially those that involve machine learning.

– Privacy & data protection; most of the data obtained by digital therapeutics is likely to be threated as health records. But patients will need to be warned about some of the risks associated with data exchange and usage.

– Accessibility; will health insurances cover digital therapeutics? What are the current discrepancies in the resources and infrastructure required to implement digital therapeutics?

– Bigotry & equity; the design and development of digital therapeutics needs  to address whether the tools are equally effective in a variety of demographics and circumstances.

Safety And Surveillance

Many mental health apps for consumers are unregulated. Furthermore, concerns about the lack of research base for consumer mental health apps have been raised. Digital remedial treatment is regulated as medical devices. As a result, the FDA in the US is in charge of ensuring that products are safe and effective. In the EU, compliance to CE marking according to the Medical Devices Directive – 93/42/EEC is required.

Two difficult tasks remain. First of all the formulating and implementing quality control procedures for algorithms that are used in digital therapies is challenging. Additionally the analysis of essential external factors (such as operating systems or connections) for supplying digital medicines continues to be difficult. Many digital therapeutics are designed to evolve over time, which may necessitate re-evaluation after initial certification.

In the US and EU, medical device regulation focuses on the product: the digital tool itself. It’s vital to remember that a digital tool will be utilized within the framework of a health-care delivery system. It is for purposes and goals defined inside that system, such as allocating available resources or treating a specific patient group. As a result, in order to assess the safety and effectiveness of a digital tool thoroughly, a systems perspective on how that tool will be utilized is also required. The scope needs a shift in perspective: from a product view (medical AI/ML-based products) to assessing systems. This is central to maximizing the safety and efficacy of Artificial Intelligence (AI) & Machine Learning (ML) in health care. The ( US-based) National Center for Biotechnology Information has offered several suggestions for US and EU regulators to make this challenging but important transition. The NCBI is aware of the significant difficulties for watchdogs. They are used to regulating products, not systems. It is evident that digital therapeutics’ responsible integration into mental health care becomes increasingly important.

Machine learning

Machine-learning-based digital tools provide extra regulatory challenges. It can be difficult to determine why certain data inputs resulted in various outputs or discoveries when using machine learning algorithms. As a result, evaluating and addressing systematic flaws in the results might be difficult. Think of biases that have a disproportionate influence on certain groups of people. The best approaches for detecting and correcting potential biases are still being developed even though there are efforts to develop algorithms that are more explainable.

There have been proposals (by NCBI ) for more transparency in health algorithms, such as allowing third-party assessment of algorithms by developers. Clinicians must also carefully evaluate how to advise patients about the risks and limitations of digital treatment instruments in order to obtain informed consent. Clinicians themselves may need to be trained in order to appreciate the limits of digital tools. Releveant contributors need to be involved in planning for the adoption and implementation of digital therapies in a health care system. From physicians to patients and community members, they can also help to resolve concerns about fairness.

Privacy And Data Protection With Digital Therapeutics’ Responsible Integration

Statistics on mental health is usually regarded as more delicate and potentially stigmatizing than data on other types of health data. A catastrophic data breach in October 2020. Hackers exploited a data security weakness in a Finnish popular psychotherapy app. That resulted in the blackmailing of thousands of users over their personal information. The security flaw opened the gateway for hackers to obtain an entire patient database, including e-mail addresses, social security numbers and maybe worst of all, the actual written notes that therapists had taken. This incident underlined the significance of effective data security procedures as well as the value of behavioral data and digital therapeutics’ responsible integration.

Personal and biometric data regulations are being reviewed by an increasing number of jurisdictions. In light of this, clinicians’ patients must understand the risks and benefits of data obtained through digital therapeutics. it should be communicated through an informed consent process. Moreover, certain digital treatments continuously monitor patients, generating a large amount of personal information. Further research should be done to see how ubiquitous surveillance affects patients and the therapeutic alliance.

Bias And Fairness In Digital Therapeutics’ Responsible Integration

Not only the COVID-19 pandemic but also recent social justice movements have put a spotlight on bias and inequities in the health care system. Because of historical health-care inequities Black and Latinx people are more likely to express worries about privacy and the quality of digital mental health services. The shift to telehealth has shown that not all communities or populations have the means or infrastructure to benefit from digital tools. In the US the equipment is less likely to be available in community mental health facilities which disproportionately serve Black and Latinx patients. If digital therapeutics are to fulfill the promise of increased access, improvements are needed in infrastructure, training, and availability of clinician oversight to better serve low-income demographics. It’s possible that additional resources, such as an internet connection or hardware, will also be required.

Machine learning and digital health technologies also raise issues of racial bias and fairness. Bigotry can take many forms. Like an insufficient fit between the data obtained and the research aim. Also datasets that lack representative samples of the target population can be a problem. Thirdly, digital technologies that have various effects depending on how they are used can be a challenge. There are several solutions to tackling bias in digital health tools. These include technological changes in datasets and algorithms as well as defining fairness principles for algorithmic tools.

Conclusion

Telehealth and digital treatments show a lot of promise for improving mental health care. However, we must strive for digital therapeutics’ responsible integration in ways that enhance the therapeutic interaction and provide fair care. Digital therapeutics pose concerns about proper lines of supervision and responsibility. They may have an impact on the nature of the guardian relationships involved. Frameworks for how digital therapeutics can address preventative care, patients in crisis, or special populations also need to be developed and implemented.

[Reference: Dr Martinez-Martin. She is an assistant professor at Stanford Center for Biomedical Ethics and in the Department of Pediatrics. She has a secondary appointment in the Department of Psychiatry at Stanford University’s School of Medicine.]

Source: psychiatrictimes.com

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Ecodesign Requirements

The new rule applies to single-speed induction motors that operate at 50 Hz, 60 Hz, or 50/60 Hz and have the following characteristics:

– 2 to 8 poles

– Single phase or three phase

– rated output between 0.12kW and 1000kW

– rated voltage from 50V to 1000V

– rated on the basis of continuous duty operation and direct on-line operation

These drives’ power losses must not exceed the maximum power losses corresponding to the new IE2 efficiency level for drives after July 1. This should not be confused with the equivalent IE2 rating for motors. In the 2019 Ecodesign Regulations manufacturers of drives had to provide power losses as a percentage of rated output. Not only at eight distinct operating stages but also as standby power.

Exclusions

The Ecodesign Requirements Electric Motors & VSDs are subject to some exceptions:

– Regenerative and low-harmonic drives where THD is less than 10%;

– Multiple AC-output drives and singe-phase drives;

– Situations where the drive forms part of a cabinet and the drive module itself has already been assessed;

– DC drives, medium-voltage drives, integrated drives, and traction drives;

Although servodrives are included, there is a catch: drives in this class which can also be used with induction motors do fall within the scope but exemptions do apply to servodrives developed solely for use with servomotors.

For Power Drive Systems, there are no minimum efficiency standards in ecodesign.

The Ecodesign standards are part of the CE certification procedure which will become UKCA marking in post-Brexit Britain (starting in January 2022). The regulations primarily cover induction motors rated for continuous duty. There certainly are complexities. Essentially if a motor is rated for direct-on-line operation then it is within the scope of the Ecodesign.

Benefits

In the EU there are around eight billion electric motors running. These use almost 50% of all electricity generated in the region. The majority of these active motors have no speed control. Considered in the context of ambitious targets for lowering emissions, energy usage, and carbon emissions, this means that high-efficiency motors and drives play an important role.

Also, which technology firms will use the Ecodesign regulations to move two or three steps ahead? The technology is already in place to go above and beyond the present standard. IE4 and IE5 motors are becoming ever more common. This ensures that manufacturers are prepared for the next round of Directive improvements in 2023.

When you consider the greater performance and lower maintenance costs of current high-efficiency motors and drives, it’s difficult to argue that the Ecodesign rules aren’t beneficial.

When you consider the greater performance and lower maintenance costs of current, high-efficiency motors and drives, it’s difficult to argue that the Ecodesign rules aren’t beneficial.

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CPSC vs Amazon: The Fight About Who’s Responsible Is On

Amazon fights responsibility for product recalls. In a previous blog we mentioned that US product safety watchdog CPSC sues Amazon for selling dangerous products. They voted to file an administrative complaint against the e-commerce giant. This is just the latest indication of the pressure on Amazon to ensure the safety of products the platform hosts. These federal agency and Congressional efforts will almost certainly cause more pressure on product manufacturers. They need to ensure the products they offer for sale on Amazon are compliant with the relevant regulations. When a product purchased from the world’s largest online store causes someones harm or death, who is to blame?

Who Is To Blame?

The answer to the above question is disputed over many years in courts and state legislatures nationwide. Amazons’ finger has always pointed to the third-party sellers that technically sold the items. In many occasions Amazon and their court-rivals pondered over the fact whether or not product liability laws contemplate online shopping or digital middlemen. Several courts agreed with Amazon. Now, CPSC is aiming for the determination that Amazon is responsible for its third-party merchants. Effectively that could hold the e-firm legally liable for failing to warn customers about defective products or allowing banned products to resurface for sale. Potentially forcing the company to spend more time and money monitoring its online store. Also, Amazon’s insurance costs would almost certainly rise as a result. This development is unwanted for the giant and that could be why Amazon fights the responsibility for product recalls.

CPSC Tries To Declare Amazon a Distributor

The agency is also seeking a precedent-setting ruling that the company based in Seattle is a consumer product distributor under federal law. That classification would subject the company to future mandatory recalls on behalf of its sellers. Declaring Amazon a distributor would overturn a typical tech industry stance, which claims that businesses like Facebook and Google aren’t liable for what’s said, uploaded, or sold on their platforms.

“If CPSC wins on this, it’s going to be a huge deal for Amazon,” says Boaz Green, a former agency staffer who now works for Neal Cohen Law advising companies that sell their products on Amazon. Product safety advocates and some in Congress have been calling for action to tame “what’s perceived as this Wild West, unregulated market, with all these small sellers they can’t get at. But they can get at Amazon, or they can try”, according to Bloomberg Law.

The Battle Is On

It is becoming a true battle now that Amazon fights the responsibility for product recalls. It involves an aspect of the retail Empire that is frequently misunderstood: the majority of things sold on Amazon.com are not owned by the Seattle-based retailer. After all, third-party sellers are technically selling them. These are not only home-made crafters, they also include a group of established brands and hundreds of thousands of Chinese manufacturers and distributors. They pay fees to be listed on Amazons’ platform. Ever more often, their program called “fulfilment by Amazon” sellers store their items in the company’s warehouses. This program also takes care of shipping and handling.

Amazon Fights Responsibility: Is It A Result Of “Fulfilment By Amazon”?

Amazon’s development was boosted by this technique, which stocked its shelves with an almost limitless supply of goods. However, the marketplace allows its vendors to sign up and manage their listings using self-service tools. Therefore it has grown increasingly difficult to control. When consumers are hurt by dangerous or counterfeit goods, they have little choice but to file a lawsuit against a corporation that has won more cases than it has lost. Now that US watchdog CSPC has sued them, Amazon fights to take responsibility for product recalls.

Are Webplatforms Liable For Content Published By Others?

Cases involving product liability have typically been decided on specific factors. Did Amazon take ownership of the products? Did they play a role in the creation of a market for a certain product? The corporation usually claims to be a neutral marketplace that connects buyers and sellers. From that perspective Amazon thinks it is immune to accountability since other companies produced item descriptions and coordinated product delivery. Section 230 of the Communications Decency Act is a legal provision that that protects web platforms from liability for content published by others. Amazon uses this section as one of their safeguards.

Amazon Has Attempted Collaborating With CSPC

Prior to the lawsuit, Amazon proposed collaborating with the Consumer Product Safety Commission. The aim was to establish a voluntary system in which Amazon and other marketplaces would organize recalls on behalf of their merchants. “It became evident that Amazon would refuse to go through formal, legally mandated recall processes”. According to a representative for the agency “this caused talks to break down”.

CSPC Chairman Says Lenghty Negotiations Are No Longer Sustainable

In a statement, acting CPSC Chairman Robert Adler lamented that before it can carry out a recall of a product sold on a marketplace, the agency typically has to go through “a lengthy negotiation” with companies like Amazon to establish whether they’re even subject to regulation. “Clearly the current approach is not sustainable,” he stated.

Amazon Is Not Easy to Take On

“This is a shot over the bow for online platforms in general”, said Creighton Magid of the lawsuit. He is a product liability and regulatory attorney with Dorsey & Whitney LLP. It’s also a gamble for the roughly 500-person agency CSPC. Their office coordinates hundreds of product recalls but rarely seeks to take uncooperative manufacturers or retailers to court. And now they do, Amazon fights the responsibility for product recalls. Magid, who represents businesses that must comply with product regulations, said the CPSC is an under-resourced agency that has to be very selective in what it does. Here, it’s “taking on an 800-pound gorilla,” he said to Bloomberg Law.

“We Can’t Let The Consumer Pay For The Harm”

“Somebody needs to pay for the harm,” says Daniel Hinkle, a senior state affairs counsel with the American Association for Justice. That is a trade group for trial lawyers. “Because if they don’t pay for the harm, it’s the consumer that does. They’re the ones who are out a home, a car or a child, or are relegated to a wheelchair for the rest of their lives.”

We continue to follow this case that potentially can have a big impact on Amazon’s business model and of the sellers that are using the Amazon platform.

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CPSC Sues Amazon For Selling Dangerous Products.

On July 14 the CPSC voted to file an administrative complaint. The US Consumer Product Safety Commission say that the e-commerce giant was legally responsible to recall the products. They posed a serious risk of injury or death to consumers. Amongst these products were carbon monoxide detectors that failed to go off. Hair dryers that lacked required protection against electrocution and children’s sleepwear garments that could catch fire. The federal safety watchdog CPSC sues Amazon for selling dangerous products in order them to stop.

Each of the products was sold by one of Amazon’s millions of third-party merchants. They all used Fulfillment By Amazon (FBA). This allows Amazon to store and distribute things on behalf of its sellers. CPSC Acting Chairman Robert Adler said: “We must grapple with how to deal with these massive third-party platforms more efficiently. How best to protect the American consumers who rely on them”. Amazon has taken unspecified actions for some of the products, according to the authority, but it was not enough.

Amazon statement about CPSC suing them

In a statement to The Verge Amazon says:

“Customer safety is a top priority and we take prompt action to protect customers when we are aware of a safety concern. As the CPSC’s own complaint acknowledges, for the vast majority of the products in question, Amazon already immediately removed the products from our store, notified customers about potential safety concerns, advised customers to destroy the products, and provided customers with full refunds. For the remaining few products in question, the CPSC did not provide Amazon with enough information for us to take action and despite our requests, CPSC has remained unresponsive. Amazon has an industry-leading recalls program and we have further offered to expand our capabilities to handle recalls for all products sold in our store, regardless of whether those products were sold or fulfilled by Amazon or third-party sellers. We are unclear as to why the CPSC has rejected that offer or why they have filed a complaint seeking to force us to take actions almost entirely duplicative of those we’ve already taken.”

CSPC’s Authority

The complaint asks for a determination that Amazon is a consumer product distributor under the Consumer Product Safety Act. It also asks for an order requiring the corporation to engage with the government to remove the risk of defective items to customers. Furthermore it seems that the CPSC’s action is about finding the authority to compel recalls on large online seller marketplaces like Amazon. The e-commerce platforms weren’t around when the regulations were enacted. It wouldn’t have to rely on Amazon’s willingness to cooperate. That is why now the federal safety watchdog CPSC sues Amazon for selling dangerous products in order them to stop.

Conclusion

CPSC’s administrative complaint is just the latest indication of the pressure on Amazon to ensure the safety of the products the platform hosts. These federal agency and Congressional efforts will almost certainly cause more pressure on product manufacturers to ensure the products they offer for sale on Amazon are compliant with the relevant regulations.

We continue to follow this case that potentially can have a big impact on Amazon’s business model and of the sellers that are using the Amazon platform.

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Currently, General Product Safety and market surveillance regulations are scattered across several pieces of legislation. As a result, they are fractured, resulting in overlaps, gaps, and confusion. The proposed bundle is intended to make this easier. Its goal is to make the standards governing consumer product safety, product identity, and traceability more consistent. It also aims to improve the coordination of how authorities inspect items, enforce regulatory compliance, and monitor the market, resulting in a more fair playing field in the internal market.

Will the amendment impact your business?

Many consumer products are covered by the General Product Safety Directive. The revision aims to ensure alignment with the content of the Market Surveillance Regulation 1020/2019. Chances are that there will be a significant impact on your business.

We understand that you want your products to comply with all requirements of the GPSD. We are conscious of the importance this may have for you. That is why we are currently analyzing the text of this proposal so that we can be of the best assistance to you when you need it.

Live presentation

Also, as an additional help, we will organize a live presentation shortly. Are interested in knowing how the changes in the General Product Safety Directive will impact your business? Leave your name and email address in the form below. Furthermore you can watch our posts on social media.

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Mr Ivan Hendrikx is the Market Surveillance expert at UNECE. ‘Market surveillance’ refers to the governmental surveillance of product safety and product compliance. Market surveillance has faced many challenges in the last few years, particularly with the dramatic increase of e-commerce. In this livestream Mr. Hendrikx will present challenges and new concepts for market surveillance systems.

The livestream starts at 7pm CET (6pm GMT, 2pm EST and 11am PST) and can be watched on YouTube and Facebook.

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Cots Safety Risks

Cots that do not meet the legal safety requirements pose risks: children can suffer head injuries by falling, body parts become trapped, or they are at risk of suffocation. The risks are not the same for all shortcomings, because the chance of the danger occurring differs. A serious danger can be, for example, the distance between the bars in the upright sides and the distance between the bed base and the upright sides. With certain dimensions between parts, there is a risk that limbs or the head can become trapped in them. If a child's bed is not stable, there is a risk that the bed will tip and the child will fall to the floor. For example, when the child stands in the bed and leans against an upright side or moves back and forth. The child can suffer a head injury during this process.

Research

The safety of vulnerable groups such as babies and toddlers is a priority at the NVWA. That is why products for those target groups are regularly monitored. In 2020, a number of brands of children's beds were examined. Cots were also tested against the European standards EN 716-1: 2017 + C1: 2019 and EN 716: 2017. The cots were examined for, among other things, stability, openings and distances between parts, distances between the bed base and upright sides and the attachment and strength of the bed base.

Of the twenty children's beds examined, eight had one or more deficiencies. The other twelve were found to be in compliance on the items examined. The shortcomings were found to vary widely; none of the items examined appeared to occur in more than two cots.

Measures

The NVWA recommends parents and / or guardians not to use the eight cots with (serious) shortcomings for children up to the age of four. The companies concerned have been ordered to stop selling these cots. In the case of cots where there was a real risk of serious injury, the companies were fined and instructed that they must immediately warn their customers and buyers and recall the cots.

The NVWA has informed the European Commission about the deviating products that have been found. Also market surveillance authorities in other Member States have been are aware of this and can act in their own country. In view of the research results (25% safety risk), the NVWA will conduct a follow-up study into the safety of cots on the Dutch market in 2022.

Source: NVWA (Dutch)

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Commissioner for Internal Market Thierry Breton declared: “The health and safety of European citizens is our priority. By ensuring that toys marketed in the EU respect the safety requirements concerning allergenic fragrances, we contribute to children growing up safely in Europe. Today’s decision was taken in collaboration with consumers organisations, industry players and the Member States.”

Since allergenic fragrances keep their potential to cause allergies independently of their use, the Commission amended the Toy Safety Directive 2009/48/EC by extending the list of 55 banned fragrances with atranol, chloroatranol and methyl heptine carbonate in toys and toy materials. On top of that, the new rules require that 61 further allergenic fragrances in toys, if present at more than 100 mg/kg, have to be labelled on the toy, on an affixed label, on the packaging or in an accompanying leaflet.The new rules will be published in the Official Journal of the EU in the next days. The labelling requirements and prohibitions will apply 18 months later in all Member States.

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With a new restriction adopted in December under the EU chemical legislation, the European Commission aims to ensure that EU citizens are equally protected, no matter the country where they get  tattooed and whether the ink is manufactured in the EU or not. Commissioner for Internal Market, Thierry Breton, said: “The Commission works hard on ensuring the safety of chemicals used in everyday products and is today restricting the use of dangerous substances in inks used for tattooing. Some EU Member States have already done that, but with this restriction we aim to harmonize these measures at EU level and to improve citizens' protection. This restriction is the result of a good cooperation between the Commission, the European Chemicals Agency and the Member States with the involvement of the industry and NGOs.” Commissioner for Environment, Oceans and Fisheries,

Virginijus Sinkevičius, said: “The health and well-being of our citizens is our priority. In addition to allergies and skin problems, toxic chemicals found in tattoo inks can cause other adverse health effects, such as cancer. Tattooing is increasingly popular in Europe. This is why it is urgent that we regulate those chemicals now.”

The new and improved rules include maximum concentration limits established either for groups of substances or for individual substances such as certain azodyes and carcinogenic aromatic amines, poly cyclic aromatic hydrocarbons (PAHs), metals and methanol. So far, EU Member States have different national rules on restriction of chemicals in tattoo inks. With the restriction adopted today, there will be harmonized rules across the EU. The new rules will become applicable in December 2021, after a transition phase of 12 months. From that point in time, tattoo inks and permanent make-up that contain the substances listed in quantities exceeding the specified limits may no longer be placed on the market and used in the EU.

More information

• REACH restrictions page
• ECHA tattoo ink page

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Maybe there is so much unclarity about CE certification because the concept was never really promoted to consumers. The value of the mark is not so much for consumers, as it is for producers and employers.

I made this short video presentation to answer some of the basic questions about CE marking and CE certification. The following questions are answered:

• What is CE marking?
• What do the letters “CE” mean?
• Who owns “CE”?
• Who is responsible for affixing the CE mark?
• What are the benefits of CE certification?
• In which countries does the CE marking apply?
• How does CE marking help trade?
• Is the CE mark a quality marking or an indication of origin?
• Which products require CE certification and must bear the CE marking?
• Does the CE marking apply to any of the following products?
  • machinery
  • foodstuffs
  • chemicals
  • electrical products
  • toys
  • pharmaceuticals
  • medical devices
  • personal protective equipment

If you like the video, please share it. I would also like to hear back from you. Please send me your questions or post your comments below. I would also like to hear your suggestions on what type of specific questions would you like me to answer in a video just like this one.

Ready to learn more about CE marking?

We have a wealth of articles and posts about this topic. Click the following link to access them:

Read more articles about CE marking and watch other videos

Does your product require CE marking?
What does CE marking cost ?
In which countries is CE marking required?
Who is responsible for CE marking?
Flowchart of steps to get CE marking?

Need help with CE marking?

At CEMARKING.NET we offer online coaching and workshops to guide you through the CE certification process. We also provide the checklists and templates you need to document your assessments and product compliance. You can start here.

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Further reading

The post CE Marking of face masks and PPE. What importers need to know. appeared first on cemarking.net.

KN95 is a performance rating under the Chinese standard GB2626:2006, the requirements of which are broadly the same as the European standard BSEN149:2001+A1:2009 for FFP2 facemasks. However, there is no independent certification or assurance of their quality and products manufactured to KN95 rating are declared as compliant by the manufacturer.

Read the full text of the warning here.

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This updated list is important to all manufacturers of CE marked machinery that have used European harmonized standards to prove CE compliance. If you have applied standards to prove compliance with the aforementioned directive, we recommend you to check the new list of standards to see if any of the standard you applied have been updated, or whether there are new standards available for your products. When standards have been updated by this list, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity.

The updated list of standards can be found here or in our Library shortly.

The post Machinery Directive 2006/42/EC: European Commission updates list of European Harmonized Standards appeared first on cemarking.net.

Commissioner for Internal Market Thierry Breton said:

We are acting swiftly and mobilising industry to increase and create new production lines for urgent health material and protective equipment across Europe. Many companies are already doing so, and we are helping them to ensure not only that this is done quickly but also that their products comply with all necessary safety standards.

Three guides

1. The first guidance helps manufacturers to assess the applicable legal and technical requirements before importing new products to the EU or launching new or reconverting existing facilities to produce protective equipment like masks, gloves and surgical gowns to satisfy the unprecedented demand in the wake of the coronavirus outbreak.The guidance issued today details the applicable EU legal frameworks and offers manufacturers' advice on the concrete steps to take in order to be able to place their products on the EU market. It also explains the role of national authorities, in particular market surveillance authorities in ensuring an adequate level of health and safety of equipment originating in third-countries, which is placed on the EU market.

2. The second document intends to provide guidance to economic operators including small and medium-sized enterprises on the applicable legal framework for the placing on the EU market of hydro-alcoholic gel (i.e. the Cosmetic Products Regulation or the Biocidal Products Regulation) and the claims which can be made to the user. It aims at responding to frequent questions the Commission is receiving from operators of the cosmetic and of other sectors, which are heavily engaged in increasing or converting their production capacity towards these products.

3. The third guide gives guidance on conformity assessment procedures for 3D printing and 3D printed products for medical use in the context of the coronavirus outbreak. The document aims to detail the applicable EU legal frameworks for those products and sets out examples of technical standards which manufacturers may use in order to place compliant products on the EU market.

Downloads:

Guidance for personal protective equipment manufacturers

Guidance for hand gel manufacturers

Guidance for 3D printing manufacturers

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This concerns almost half of a batch of 1.3 million so-called FFP2 masks, 600,000 pieces. Healthcare providers use it to treat critically ill patients with Covid infection. Faulty masks put doctors and nurses at risk.

The masks have been rejected by the research institute TNO because they do not meet the safety requirements. They do not fit well on the face or have membranes that do not function properly, the very fine filters that have to stop virus particles.

The masks are already distributed among the hospitals. “The face masks that are not satisfactory are being retrieved,” the Ministry of Health told the Dutch television. “We have no overview of whether the defective face masks have also been used in hospitals.”

Tested on hospitals’ own initiative

A number of hospitals had the masks tested by TNO on their own initiative. The batch of masks had already been distributed among the hospitals in the Netherlands without having been tested to see whether they meet the quality requirements.

“When they were delivered to our hospital, I immediately rejected those masks,” said a person from a hospital who received a batch of defective masks. “If those masks do not close properly, the virus particles can simply pass. We do not use them. That is unsafe for our people.”

TNO is not allowed to provide information about the results and results of the tests. “That is contractually stipulated,” said a spokesperson.

Appalling quality

The rejected face masks are said to be of low quality. Not of FFP2 quality nor of the lesser level of safety FFP1. “Some sort of FFP0.8 at best,” said this source.

It is not clear whether the rejected masks are already in use in Dutch hospitals, but that is not imaginary given the large shortages.

Update

On Sunday 29 March, Dutch Minister Martin van Rijn for Medical Care met with the Chinese ambassador in The Hague to discuss a shipment of rejected face masks from China.

“Talked to Chinese ambassador Xu Hong about the rejected masks, the Minister tweeted on Sunday. “But also thanked China for their support to fight the coronavirus in the Netherlands. We are working together to ensure that all protective equipment meets quality requirements.”

The Chinese ambassador tweeted that he had a “good conversation” with Van Rijn. He is waiting for more detailed information about the rejected masks, he said, adding that he hopes “this isolated incident” will not impact the two countries’ joint fight against the coronavirus.

The demand for face masks to protect healthcare workers against the coronavirus is sky-high worldwide. China is currently the only country that can supply these masks on a large scale.

On Monday the union for nurses and other healthcare workers NU’91 launched an online reporting pointwhere healthcare workers can report shortages of protective equipment. The union hopes that this will help map out exactly what is needed where.

Sources: nos.nl, nltimes.nl

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The proposal is expected to be ready early April 2020.

The postponement will give the authorities, notified bodies and manufacturers the opportunity to fully focus on the corona crisis and the effect on their activities.

The post The European Commission confirms proposal to postpone the MDR appeared first on cemarking.net.

The standards on these list may be used by medical devices manufacturers to prove that their equipment complies with the essential requirements of this directive.

These updated lists of European harmonised standards are important to all manufacturers of CE marked medical devices or in vitro diagnostics that have used European harmonized standards to prove CE compliance.

If you have applied standards to prove compliance with the aforementioned directive, we recommend you to check the new list of standards to see if any of the standard you applied have been updated, or whether there are new standards available for your products. When standards have been updated by this list, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity.

The updated list of standards can be found in here, as well as in our Library shortly.

The post Medical devices and IVDs: List European harmonised standards updated appeared first on cemarking.net.

The MDCG provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746.

New MDCG guidance documents:

MDCG 2020-1: Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of Medical Device Software: This guide provides the framework for identifying the appropriate level of clinical evidence required for Medical Device Software (MDSW) to meet the requirements of the MDR.

MDCG 2020-2: Class I Transitional provisions under Article 120(3 and 4) – (MDR): This guide describes the relevant information to be included in the manufacturer’s Declaration of Conformity (DoC) under the MDD for Class I (non-sterile/non-measuring) devices that must have MDR certificates after May 24, 2024.

MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD: This guide specifies what constitutes a “significant changes in design or intended purpose” under Article 120(3) of the MDR. It also states that such changes will no longer be issued new MDD/AIMDD certificates. Also, the device will be prevented from being placed on the market under the MDD/AIMDD after the implementation of the MDR. Finally, the guidance includes decision flowcharts to help manufacturers decide whether or not a change to a device will be considered significant.

Revisions to existing guidances:

MDCG 2018-1 v3: Guidance on BASIC UDI-DI and changes to UDI-DI: The revisions of this guide include additional criteria to consider that may or may not warrant a new UDI-DI under the “Changes of UDI-DI section.”

MDCG 2019-8 v2: Guidance document on Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices: The revisions include a clarification of the “MD” symbol (Footnote 7) and a note on language translations provided in the implant card examples (Footnote 9).

Our members can download the texts of these guides from the Library.

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Upon the urgent request of the Commission, the European standards bodies CEN and CENELEC, in collaboration with all their members, have agreed to immediately make available a number of European standards for certain medical devices and personal protective equipment. This action will help both EU and third-country companies willing to manufacture these items to swiftly start production and place products on the internal market more easily while ensuring a high degree of safety.

The agreement has immediate effect. The 11 standards developed by CEN and potentially 3 additional ones developed jointly with ISO that are made available cover common filtering masks, medical gloves and protective clothing.

How the free access to these standards helps increasing production

Providing free access to the national adoptions of these European standards helps both EU and third-country companies which are reconverting their production lines to manufacture quickly these critical items for preventing the coronavirus pandemic. The use of the standards will enable companies that use them to access the market for such fundamental medical and protection equipment quicker and to provide those in need with such medical equipment.

Normally, standards must be purchased and used in line with the intellectual property right rules. The copyright of the standards lies with the organisations, which have developed the standards. The derogation from this business model is a strong European response to address the shortage problem of protective equipment deriving from the Covid-19 epidemics.

The standards are available for free download from the websites of CEN national members.

List of available standards:

• EN 149:2009 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking (commonly referred to as ‘FFP masks’
• EN 14683:2019 EN Medical face masks – Requirements and test method
• EN 166:2001 Personal eye-protection – Specifications
• EN 14126:2003 Protective clothing – Performance requirements and tests methods for protective clothing against infective agents
• EN 14605:2009 Protective clothing against liquid chemicals – performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only
• EN 13795-1:2019 Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns
• EN 13795-2:2019 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment – Part 2: Test methods
• EN 455-1:2000 Medical gloves for single use – Part 1: Requirements and testing for freedom from holes (MDD)
• EN 455-2:2015 Medical gloves for single use – Part 2: Requirements and testing for physical properties (MMD)
• EN 455-3:2015 Medical gloves for single use – Part 3: Requirements and testing for biological evaluation (MDD)
• EN 455-4:2009 EN Medical gloves for single use – Part 4: Requirements and testing for shelf life determination (MDD)

In addition, possibly:

• EN ISO 374-5:2017 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks
• EN ISO 13688:2013 Protective clothing – General requirements
• EN ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

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US manufacturer Cook Medical is hiring 20 new full-time roles in its Limerick base, which is largely responsible for compliance with the EU’s Medical Device Regulation (MDR).

“These roles are part of a larger recruitment drive globally, specific to the EU MDR,” Sinead Burke, director of regulatory affairs at Cook Medical Europe, told Fora. “We have also taken on over 70 new contract roles globally to help with the implementation of EU MDR.”

The MDR is a set of new rules passed by European lawmakers in 2017 that will introduce much stricter clinical reporting and post-market surveillance responsibilities for device makers.

Recruitment at Cook Medical is mostly around roles in regulatory affairs and engineering to meet this new system.

Burke explained that “key changes within the regulations required us to invest in these new roles” to put more emphasis on clinical and post-market clinical follow up procedures.

She said the regulation change will have a “big impact” on all six of Cook Medical’s manufacturing sites worldwide.

“(It) will integrally change the way we work in a lot of key areas of our business, but we are fully committed to making sure we are compliant and embrace this new legislation as a positive step.”

Medical device giant Stryker is also carrying out a similar strategy. The firm, which employs more than 3,500 people in Ireland, is recruiting engineers and project managers at its Cork plant specifically for MDR work.

Medtronic, the world’s largest medical device maker that is formally headquartered in Dublin, declined to comment on its recruitment efforts, but a spokesperson said it has “created a comprehensive implementation plan to transition our products to the new regulation”.

The company has a number of people working on compliance vigilance in its Ireland operations.

Preparedness

While medical device makers are making strides in being compliant, there are still many areas of the system that are concerning the industry, particularly in relation to notified bodies, organisations that are designated by the European Commission to certify devices for the market.

While the legislation was passed in 2017, only seven notified bodies have been approved. There are dozens across the European market.

This slow pace has led to fears of limited resources to meet the rush to get devices checked by May 2020 to avoid any shortages of products.

Cook Medical’s Burke said that the company has been advocating a more streamlined approach to the notified bodies system.

“The timeline set out within the regulation at the notified bodies means to date (seven) notified bodies have been designated with only seven months before date of application,” she said.

“There are much fewer notified bodies than previously, with some recent fallout and an increase workload on notified bodies, which makes for a worrying trend.”

Source: Jonathan Keane of Fora.

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The overarching goals of the plan are to put the UK at the forefront of the life sciences industry, thereby cutting the time it takes for patients to access medicines and to give it a leading role in efforts to cure rare diseases. To achieve those goals, the government plans to “remove unnecessary bureaucracy for the lowest risk clinical trials, encouraging the rapid introduction of new medicines.” The outgoing EU clinical trial rules were criticized in some quarters for imposing excessive burdens on small, low-risk studies. The planned loosening of the UK rules is part of a push to make it easier for hospitals to trial and make medicines and diagnostics devices.

The government also wants to use the legislation to drive the Medicines and Healthcare products Regulatory Agency (MHRA) to develop regulations to help companies “break new ground in complex clinical trials.” Other plans discussed in the briefing document include the implementation of a scheme to stop fake drugs from entering the supply chain, plans to register online retailers and the creation of a framework that supports the updating of legislation. The government wants the ability to update legislation on all aspects of life sciences in response to patient safety issues and changes to the UK’s future global relationships.

The government presented details of the planned bill as part of the Queen’s Speech, which is used to set out the legislative agenda for the upcoming parliament. On this occasion, the Queen’s Speech took place in an unusual context that means it is questionable whether any of the proposed texts will be debated and passed. As it stands, the government lacks a majority to pass legislation, meaning it would need to rely on the support of opposition parties to bring the Medicines and Medical Devices Bill into law. The likelihood of the current parliament passing the law is further diminished by the fact that observers expect a general election either this year or in 2020. If the government wins the election, it may then make the Medicines and Medical Devices Bill part of its legislative agenda for the next parliament.

Source: RAPS Link

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Guidance can be found via the link here. Please see page 78 and further for the guidance on the various legislation per industry sector.

In summary, if there is no deal:

The UK would manage its own set of regulations on manufactured goods separate from the EU if we leave without a deal, and UK businesses exporting to the EU would need to meet EU rules.

Many manufactured goods sectors, such as chemicals, aerospace goods, human and veterinary medicines, medical devices and automotive vehicles, are subject to common rules across the EU. These rules establish common requirements for manufacturing, testing and marketing products from these sectors. Currently, it is a legal requirement to follow these rules before selling regulated products in the EU.

Having separate regulatory regimes for manufactured goods will mean that:

• The UK will be able to set its own regulations that the businesses in the EU and other countries will have to follow before selling products on the UK market. This means that the UK could set regulations for imports into the UK rather than having to follow EU regulations.
• UK businesses exporting to the EU will need to make sure they meet EU rules. This includes, where relevant, having goods approved by EU-based bodies or having legal representatives in the EU.
• Approvals and authorisations on goods issued by UK bodies will not be accepted in the EU, even where these meet EU regulations or were issued by a UK body while the UK was still an EU member state. However, there are some exceptions to this if the EU has made a short-term commitment to accept goods.
• The UK will no longer be part of any ongoing EU agency or regulator activities. For human and veterinary medicines, chemicals and aerospace products, the relevant EU agencies which play a role in regulating goods are the European Medicines Agency (EMA), the European Chemicals Agency (ECHA) and the European Aviation Safety Agency (EASA) respectively. UK regulatory bodies will no longer be able to license products for the EU market and the UK will no longer participate in relevant committees.
• UK regulators will take on regulatory functions currently carried out by EU regulatory bodies.
  

The UK Government’s preparations for leaving without a deal:

• The Government has introduced new regulations to accept goods made against EU rules (including goods subject to assessments made by EU conformity assessment bodies) in the UK. This will mean that goods with the CE mark (which also include toys, electronics and machinery) can still be sold in the UK.
• The Government will provide continuity in goods regulation for a temporary period after exit day in order to provide as much stability as possible for businesses immediately following the UK leaving without a deal.
• For the automotive, chemicals and medicines sectors the UK is putting in place light-touch processes to allow businesses to convert existing EU approvals into UK approvals.
• The UK Government will introduce a new UK regulatory framework for CE-marked goods that will allow manufacturers to show that products meet UK rules and can be sold in the UK. This will include introducing a UK-only mark -called the UKCA mark -and a system of UK Approved Bodies. The UK Government published advice on using the UKCAmark.
• The CE mark will be retained for medical devices to ensure continued access for UK patients. Section B sets out the UK Government’s preparation for the regulation of medical devices.
• The UK Government has published technical notices on placing manufactured goods on the UK and EU markets after Brexit, as well as on what has changed across the product safety and legal metrology regimes, and consumer rights. There is dedicated, tailored advice available for the chemicals, medicines, veterinary medicines, construction, aerospace, rail and automotive sectors.
  

The UK Government has intensified preparations since 24 July 2019 on the following topic:

• The UK Government is preparing a new public database of conformity assessment bodies who will be able to assess products against UK rules before they are UKCA-marked.
• The UK Government will engage with industry before making any changes to regulatory arrangements, and, in the event of any changes, the UK Government is committed to giving sufficient notice of any change. The UK Government will give two years’ notice of any changes to regulations for medical devices.
• The UK Government has refreshed the information in all of the aforementioned technical notices with up-to-date advice for businesses.
  

What Brexit Means For Businesses:

All businesses who manufacture, trade or distribute manufactured goods should take action.

All businesses who manufacture, trade or distribute manufactured goods should take the following actions:

• Check all relevant guidance available on GOV.UK and pay close attention to the UK Government’s Brexit communications campaign for more details on the actions required to prepare if we leave without a deal.
• Check whether they need new product approvals, whether they need to appoint new representatives in the EU, make changes to the labels and markings on their goods, or submit information to new UK systems.
• Check what actions they or their suppliers need to take in relation to the manufacture and import of chemicals so that they continue to receive necessary ‘input’ goods. These actions are listed below.
  

Manufacturers of goods currently regulated under the EU’s ‘new approach’ (i.e. mostly CE-marked goods) should take the following specific actions:

• Businesses exporting CE-marked goods should check whether their goods are supplied in the EU via an EU-based distributor. If so, that distributor will become an importer. UK distributors of CE-marked goods from the EU will also become importers. Importers have certain legal responsibilities, including making sure products are accompanied by their address.
• Where businesses are required under EU law to get third party approval of their goods, they should confirm whether current approvals are issued by a UK or EU-based notified body. If unsure, the business will need to check with its notified body as in some cases, they may be making arrangements on businesses’ behalf. If the business uses a UK notified body but plans to continue to export CE-marked goods to the EU, further arrangements should be made to have the products approved by an EU recognised notified body. To do this, the business can either get the products reassessed by an EU recognised notified body or arrange for the files to be transferred to an EU notified body before the UK leaves the EU.
• If the business only sells to the UK market and uses a UK-based notified body, action should now be taken to be ready to use the UKCA mark.
• For medical devices, there will be no UKCA marking so all devices sold in the UK will continue to require the CE marking (see below for details).
• Businesses who currently use an Authorised Representative to act on their behalf should confirm where their Authorised Representative is located. EU-based Authorised Representatives who received their mandate before 31 October 2019 will still be recognised in the UK after 31 October 2019. However, a UK-based Authorised Representative will not be recognised in the EU as able to fulfil this role after 31 October 2019.
• UK businesses who export machinery to the EU will need to make sure they have nominated a person authorised to compile technical files who is based in theEU. This person could also be an importer or Authorised Representative.
• Where businesses have made any changes to how their product is approved or marked, or if there is a new importer or Authorised Representative, they should draw up a revised declaration of conformity with the correct details. Where the CE marking is used, this should still be an EU declaration of conformity. If the UKCA marking is used, then it will need to be a UK declaration of conformity.
• Businesses that self-certify compliance withEU law and place the CE marking on the product can continue to do so.
  

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