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EU survey alert: Share your thoughts on medical device regulations (MDR/IVDR)!

EC survey for MD and IVD manufacturers and AR on the status of the MDR/IVDR implementation!

This survey is being endorsed by the European Commission (DG SANTE/HaDEA) to gather information and data regarding the progress of implementing Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

We urge all our clients, including those intending to introduce products to the EU/EEA market within the next two years, to support this effort by participating in the survey! 

The goal is to gain an accurate understanding of the status of MDR/IVDR implementation, and your input is incredibly valuable. The European Commission seeks information, also concerning orphan devices and low-volume medical devices that might vanish from the EU market. This data will guide future directions and the implementation of necessary measures.
Here is the PDF version of the survey along with the endorsement letter from the European Commission.

Link to the survey: https://ec.europa.eu/eusurvey/runner/MFandAR

Survey deadline: 15 January 2024 (23:59 CET)

SAVE-THE-DATE 

Webinar with the study team with details on the survey background and the survey structure: 

Thursday, 7 December 2023*, 1-2pm CET (no registration needed)

https://us02web.zoom.us/j/85169178337?pwd=Qy94NFZwa2M0VWZpYWxyc0JCK3h3UT09 

Meeting ID: 851 6917 8337, Passcode: 442308

*another webinar is likely to take place in the near future

Categories: News
Tags: EU MDR IVDR

Flowchart for determining eligibility under the extended MDR transitional period for Devices

The Commission just published a Flowchart to assist manufacturers and stakeholders in determining device coverage under the extended transitional period of the MDR. 

The purpose of the flowchart is to aid manufacturers and other relevant stakeholders in making a determination about the inclusion of a device within the extended transitional period outlined in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), as revised by Regulation 2023/607. This flowchart is designed to facilitate the assessment of whether certain devices meet the criteria, adhere to the stipulated conditions, and meet the specified deadlines for the placing on the market or putting into service as outlined in Article 120 of the MDR. 

While using the flowchart you are advised to refer to the MDR text, which holds precedence over the flowchart, as well as to consult the Q&A addressing practical aspects related to the implementation of Regulation (EU) 2023/607. 

MDSS provides assistance in going through the flow chart or the Q&A to ensure the accurate application of the extension and the establishment and availability of the relevant documentation, which may be requested by authorities and other parties such as importers. 

Book your appointment here!

Categories: News
Tags: MDR

Official Q&A on the extension of the MDR published!

BSI supports its clients with their own FAQ

We are pleased to announce that the highly anticipated Q&A clarifying several aspects regarding the latest extension (Regulation (EU)2023/607) has been published.
We would also like to thank our clients for their valuable feedback, which greatly contributed to the success of last week's MDSS Seminar. During the seminar, we covered a number of important aspects, with the most pressing question being - when can products can be sold again??? This topic has been addressed in Question 7 of the Q&A: “The extension of the transitional period and the concomitant extension of the certificate’s validity is done automatically by law, …” (subject to certain conditions).

Another important question raised during the seminar was - how to demonstrate the validity of an expired Certificate??? In response to this, Question 7 offers several options:

  • Self Declaration based on a harmonized Template; 
    • MDSS comment: It would be beneficial if the Commission could publish this template. Alternatively, one could seek help from prominent trade associations in the EU who may have a proposal.
  • Confirmation letter issued by the NB acknowledging the receipt of the application and confirming the written agreement is in place, without incurring any extra cost;
    • MDSS comment: The NBs work together on such a letter. However, this letter may not cover all the conditions. The NBs have not received the task to check and confirm that conditions are met due to their constraints in resources.
  • The CA should be able to issue Free Sales Certificates;  
    • MDSS comment: This could potentially be the most effective approach. The CA would likely conduct checks to ensure that the conditions are met, rather than solely relying on self-declaration
  • The Commission will update its factsheets for CA outside the EU;
    • MDSS comment: This could support the manufacturer, however, a third country may still wish to verify that the conditions are met.

We are also excited to inform you that we are working on a one-step approach that will enable the Authorized Representative to support the manufacturer with a single document indicating that all necessary conditions have been checked and confirmed. This will provide our clients with a much-needed solution and will be available in the near future.

BSI has issued their own FAQ, which focuses on the involvement of the NB. They have confirmed that they are working with other NBs on a harmonized letter and have advised those who switched back  or consider to switch back to the BSI normal service, due to the extension, that they will find themselves back in line. 

We remain committed to supporting our clients and will continue to provide updates as they become available. 

Comment on youregulate...

Categories: News
Tags: MDR European Commission

Extension of the MDR for legacy devices!

On February 16, 2023, the European Parliament adopted the extension of the transition period for the EU MDR and to extend the validity of certain device certificates (here is  MDSS' outline on the proposal extension and on Article 97). See how Switzerland and the UK reacted in their official pages.

*The adopted proposal still has to go through the legislative procedure to be adopted as law!

Join our Online Seminar where we will discuss the extension and the impact of Article 97 and address how Switzerland and the UK are acting!

Categories: News
Tags: EU MDR IVDR UK Switzerland

New Features and Improvements in EUDAMED Production v 2.10

EUDAMED Production v 2.10 has been released with several new features and improvements.

Are you ready for the latest and greatest version of EUDAMED Production? Look no further than version 2.10, which comes with a range of exciting new features and improvements. In this post, we'll provide you with a brief overview of what's new, including updates to the Actors module, UDI/Device module, NB & Certificates module, and DTX.

One of the key features in the Actors module is the ability to set an Economic Operator as inactive, which creates a new version of the Economic Operator with the new status. The UDI/Device module now allows you to search for devices by indicating the Competent Authority (CA) responsible for the manufacturer, while the NB & Certificates module lets you register refused certificates, refused applications, and withdrawn applications of type product.

In addition to these exciting new features, EUDAMED Production v 2.10 also includes several user experience and user interface improvements, various fixes, and updates to the DTX. So if you want to operate more efficiently in EUDAMED, be sure to upgrade to the latest version today. Read the full document here.

For more news and updates from the medical device industry, be sure to check out MDSS News & Views.

Categories: News
Tags: MDR EUDAMED IVDR European Commission

Key Terms and Concepts in the Medical Device Regulation - Vigilance

The vigilance requirements under the EU's medical device regulations can be complex and confusing. To help you navigate this landscape, the Medical Device Coordination Group (MDCG) has released a guide to key terms and concepts in Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR).

This guide is a valuable resource for anyone involved in the medical device industry, including competent authorities and economic operators. It establishes a common understanding of important definitions and concepts necessary for effective implementation of vigilance requirements.

The guide includes definitions from the Guidelines on a Medical Devices Vigilance System, modified where necessary for alignment with the MDR. It covers medical devices, accessories for medical devices, and products listed in Annex XVI to the MDR.

While the guide is non-exhaustive, it should be read in conjunction with the MDR, relevant standards, and other MDCG guidance documents. Note that terms and concepts outlined in the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) are outside the scope of this guide.

In conclusion, our guide to key terms and concepts in the MDR is a must-read for anyone looking to understand the vigilance requirements under the EU's medical device regulations. Access this valuable resource to gain a clear understanding of these requirements and ensure effective implementation.

Download the document here: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices .

For more news and updates from the medical device industry, be sure to check out MDSS News & Views.

Categories: News
Tags: MDR Vigilance EU MDCG

Understanding the Clinical Evaluation Consultation Procedure Under EU's MDR Regulation

The EU's Medical Device Regulation (MDR) has brought new requirements for the conformity assessment of high-risk medical devices. This regulation includes the implementation of the Clinical Evaluation Consultation Procedure (CECP) for certain class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product. The CECP is an important procedure that provides independent scientific opinions on the clinical evaluation assessment report, which is critical for manufacturers to receive valuable feedback and improve their products. 

It's essential for manufacturers to stay informed and compliant with the requirements of the MDR as it comes into effect. From April 2021 to June 2022;

  • 215 notifications were sent by notified bodies (NBs) under Article 54(3) of the EU's MDR.
  • 24 devices (11.2%) were subject to the CECP
  • While 191 devices (88.9%) were exempt from the CECP according to Article 54(2)b.
  • The experts screened 24 CECP applications and provided an opinion for 6 out of the 24 CECP applications received (25%).
  • On June 30, 2022, 5 opinions were delivered by the expert panels, and one opinion was still under development. The secretariat did not receive any justification from NBs not following the advice provided by the expert panel.

The implementation of the CECP under the EU's MDR regulation is a significant development in the medical device industry. It will bring higher levels of safety and quality to medical devices, ensuring that they meet the required standards.

This will provide peace of mind to patients and healthcare professionals, who can rely on the safety and quality of medical devices. In conclusion, it's crucial for manufacturers to stay informed and up-to-date with the requirements of the CECP under the EU's MDR regulation. The CECP will play a critical role in ensuring the safety and quality of medical devices and provide valuable feedback to manufacturers.

Do you think the implementation of the CECP will have a positive impact on the medical device industry and the safety of medical devices? 

For more news and updates from the medical device industry, be sure to check out MDSS News & Views

Categories: News
Tags: MDR Clinical Evaluation

Handling of Certification Gaps according to MDCG 2022-18

The Medical Device Coordination Group (MDCG) has released a new document that provides guidance on handling certification gaps for medical devices in the EU/EEA. The document, MDCG 2022-18, addresses the procedures for handling certification gaps for medical devices in the EU/EEA and provides guidance on market surveillance procedures for member states...

Overview: Handling of Certification Gaps according to MDCG 2022-18 in Switzerland

MDCG 2022-18 outlines the procedures for handling certification gaps for medical devices in the EU/EEA. The document provides guidance on the steps that should be taken by member states to ensure that medical devices are safe and effective. It also addresses the procedures for market surveillance and the measures that should be taken by market surveillance authorities in the event of a certification gap.

Reliance on MDCG 2022-18 Confirmations of EU/EEA Member States

MDCG 2022-18 also provides guidance on the reliance on confirmations of EU/EEA member states. The document states that member states should rely on the confirmations of other EU/EEA member states when assessing the safety and effectiveness of medical devices. This helps to ensure that medical devices are safe and effective

Market Surveillance Procedures according to MDCG 2022-18 in Switzerland

MDCG 2022-18 also provides guidance on market surveillance procedures for member states. In Switzerland, the procedure for market surveillance is outlined in the document, including the steps that should be taken by market surveillance authorities in the event of a certification gap.

Surveillance and Measures by Swiss Market Surveillance Authorities

The document also addresses the surveillance and measures that should be taken by market surveillance authorities in Switzerland. This includes procedures for monitoring the market for medical devices and taking appropriate measures in the event of a certification gap.

Free Sales Certificates

MDCG 2022-18 also provides guidance on the issuance of free sales certificates for medical devices. This includes the conditions that must be met for a device to qualify for a free sales certificate and the procedures for issuing the certificate.

Frequently Asked Questions

The document also includes a section with frequently asked questions about the handling of certification gaps for medical devices in the EU/EEA. This provides additional information and clarification on the procedures outlined in the document.

You can download the document here.

Don't miss out on this important information and stay updated with the latest guidelines on handling certification gaps for medical devices in the EU/EEA. Follow our Linkedin account.

For more news and updates from the medical device industry, be sure to check out MDSS NEWS & VIEWS. 

Categories: News
Tags: MDCG MDR IVDR Swissmedic Switzerland

Standard Fees for Notified Bodies under MDR and IVDR

The Medical Device Coordination Group (MDCG) has released a new document, MDCG 2023-2

This document, endorsed by the Medical Device Coordination Group (MDCG), outlines the standard fees for conformity assessment activities carried out by notified bodies. This document is intended to help notified bodies establish their own lists of standard fees for these activities and make them publicly available, as required by the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The MDCG explains that standard fees should be made directly and easily accessible on the website of the notified body, and should be written in the same language as the website. Additionally, the MDCG provides templates for the "List of Standard Fees" to assist notified bodies in defining their own fees for conformity assessment activities. These fees can include flat fees, hourly fees, and fees based on the specific type of activity being performed.

The MDCG clarifies the meaning of “publicly available”, which “implies that a member of the public can access this information at any point in time, without the need for additional steps.” This means that the list of fees should be easily accessible on the website of the notified body without any additional steps, for example, without the need to register as a user of the website or provide contact data. The format of the standard fee table could be any that is accessible on a common website browser.

Moreover, the currency shown should be relevant to the country where the notified body has its registered place of business. If there are regional differences in fees charged depending on the location of the manufacturer, this should also be indicated.

In conclusion, the document serves as an important guide for notified bodies to establish their own fees for conformity assessment activities in line with the MDR and IVDR regulations. The goal of this document is to provide greater transparency and fairness in the fees charged by notified bodies for their conformity assessment services.

Download the article here.

For more news and updates from the medical device industry, be sure to check out MDSS NEWS & VIEWS.

Also available in www.youregulate.com ...

Categories: News
Tags: MDR IVDR MDCG

Proposal for amending the medical devices transition - feedback open!

Commission proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices is open for feedback until January 18, 2023. All feedback received will be summarised by the Commission and presented to the Parliament and Council with the aim of feeding into the legislative debate. 

MDSS' already submitted feedback and our proposal would allow all legacy products to enter the MDR process immediately. See here our feedback and give your own opinion to the Commission here.

Comment on youregulate...

Categories: News
Tags: European Commission MDR IVDR

Proposal for amending the medical devices transition extension was published! 

The proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices was adopted on January 6, 2023 by the Commission. The Parliament and the Council will now have to adopt the proposal via an accelerated co-decision procedure. 

See here the official press released and here the proposal.

Key elements of the proposal according to the Commission press release:

  • For medical devices covered by MDR Article 120.3, the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. The extension will be subject to certain conditions, so that only devices that are safe and for which manufacturers have already taken steps to transition to the rules provided for by the Medical Devices Regulation will benefit from the additional time.
  • The proposal introduces a transition period until 26 May 2026 also for class III implantable custom-made devices, giving their manufacturers more time to obtain certification by a notified body. Also in this case, the transition period is subject to the application of the manufacturer for a conformity assessment of devices of this type before 26 May 2024.
  • To reflect the transition periods put forward by these amendments, the proposal extends the validity of certificates issued up until 26 May 2021, the day when the Medical Devices Regulation became applicable.
  • The Commission also proposes to remove the ‘sell-off' date currently established in the Medical Devices Regulation and in the In Vitro Diagnostic Medical Devices Regulation. The ‘sell-off' date is the end date after which devices that have already been placed on the market, and remain available for purchase, should be withdrawn. Removing this ‘sell-off' date will ensure that safe and essential medical devices that are already on the market remain available to healthcare systems and to patients in need.

For the next steps, the proposal still has to go through the legislative procedure to be adopted as law!

Comment on youregulate...

Categories: News
Tags: European Commission MDR IVDR

Products without an intended medical purpose!

The regulation (EU) 2022/2346, released on 1 December 2022, lays down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745.

The transitional provision are explained in Article 2 and 3. Some provisions will enter into force on 22 December 2022. Here you can find the whole document.

The provisions in this document may provide a taste for the new transition of all other legacy products discussed here last week. If we apply this, then certificates may safely expire, however, a Notified Body will need to be engaged for surveillance activities. This can be your current MDD Notified Body or your new MDR Notified Body. 

Can this be even more complicated?? In any case, we are just curious about the cut-off date. 

An early date would be good for many manufacturers, however, it may already be too late for some other manufactures who stopped their products and disengaged from a Notified Body.   

Comment on you regulate.com...

Categories: News
Tags: MDR European Commission

EU MDR BRIDGE

Deadline/transition - further info!

What else happened last Friday, next to the proposed extension of the MDR Deadline for legacy products (see our Newsletter from Monday)?  

The MDCG 2022-18, a very special guidance, was published, intended to guide in particular authorities, to help manufacturer to bridge to the MDR. This is needed since the deadline extension will most likely have a cut-off date. 

The MDCG 2022-18 clarifies and tries to harmonize Article 97 on “Other non-compliance”.

What is clarified:

  • A missing certificate is just a non-compliance!
  • The allowance from one CA to market the products is valid for the whole EU.
  • Free Sales certificates may be issued.

What is harmonized:

  • Member states should apply the process and accept documents in a similar manner
  • Member states agree on a standard communication

Some of the rules, in particular the limitation to one year or to SMEs, cannot be found in the MDR. In any case, it may be wise, if not existential, for companies to go this route and if indeed the device is safe and this can be demonstrated objectively, then a member states may not have a choice but to allow the marketing of the products.

MDSS has already successfully supported several clients in navigating them through these complex procedures and enabling them to market the products despite facing the expiration of the MDD certificate and not being MDR certified yet. 

We are looking forward to supporting all our clients as EC REP!

Comment on youregulate.com...

Categories: News
Tags: MDR European Commission

EU MDR deadline/transition!

Is Europe preventing the Chaos and getting back to Order with this extension proposal?

The outcome of last Friday's, December 9, 2022, EPSCO meeting was that, indeed, the transition period of legacy products is going to be extended!

  • Until 2027 for risk class IIb and III
  • Until 2028 for risk class IIa and class I up-classified

Additionally, there was the removal of the sell-off period. However, this might not help Manufacturers located outside the EU, since the Importer is the one placing the product on the market. Further clarifications may be needed from the Commission.

Among others, the extension was announced in this paper. The member states had a chance to express their views on the topic and there was, in fact, great support. If you are interested, you can watch here EU law making in progress. 

The details still need to be provided and the proposal must go through the legal process before implementation.

Unfortunately, details are yet to follow and the big question to be answered now is: from which date are legacy products being included? It could be that certificates which have expired are as well honored. However, there might be a cut-off date which does not include your certificate.

Therefore, the outline is to follow Article 97!

Comment on youregulate.com...

Categories: News
Tags: MDR European Commission

Exciting developments regarding Harmonized Standards!

M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council

Read more...

Categories: News
Tags: MDR Harmonized Standards

MDR Delay!

2020.04.24

In writing and set in stone with the publication on the Official Journal of the European Union.

Here is the publication.

2020.04.20

On Friday, April 17, 2020, the European Parliament approved to delay by one year the EU Medical Device Regulation with 693 votes in favor, 1 against and 2 abstentions. A great support!



HOWEVER, the proposal now has to be approved by the member states and published in the Official Journal before taking effect. This should only be a formality.



The delay is due to the COVID-19 fight but it will be beneficial for others as well. Here is the European Parliament press release.


The 12 month delay is just a short period considering that the Importer will now request MDR compliant products. This special issue will be covered by our Webinar.

2020.04.03

The European Commission adopted a proposal to postpone the implementation of the EU Medical Device Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions.


Here is the full proposal.

2020.03.25

Medtech Europe asked the Commission to delay the MDR. Here is the Press release.



German association supports the initiative and it seems that the German Ministry of Health is responding to this positively.



Peter Liese MEP who was one of the lead Parliament member for the implementation for the MDR and IVDR is communicating that he believes it is necessary that the MDR must be postponed. Here is his twitter post.



MDSS certainly supports such initiative for the sake of the patients affected by the current situation and our clients during this difficult times. A delay will release resources to cope with the current situation as well important products which may have been banned due to the MDR requirements can still be placed on the market.



Here is the College meeting of 25/03/2020 video

Categories: News
Tags: MDR

Notified body number 11!

The notified body (NB) designation is moving along. Congratulation to NSAI. We have to note the scope NSAI shows as one of the smaller notified bodies. It includes active implantable medical devices. Well Done!

However, we like to congratulate all NBs who have made it to the Nando Website as of today.



Early this year it was communicated that 3 more notified bodies are in the pipeline. After DNV GL Presafe and NSAI we are waiting for the third one to be published. We may not see a big wave and we may see the majority of NBs notified after May 26 – the application date of the MDR!



This means that the additional transition as provided by MDR Article 120 (3) is the norm and not the exception.  



What else is there to note:


1. BSI UK is still listed and will stay on the list because the Brexit deal provides for business is as usual - at least until the end of this year (see MDSS N&V here).


2. The notified bodies must train all the auditors and experts to the MDR requirements. They must be reviewed in regards to their qualification and experience (see MDR Annex VII). This is a lot more cumbersome as with the directive. Clients reported that their auditor stated that they would not come back due to their lack of qualification under the MDR. I guess someone may ask the question whether those were actually qualified under the MDD!


3. Even before quoting the service the NB shall conduct a preliminary verification that the product is covered by the MDR and the classification (Annex VII 4.2 d).


4. Article 50 requires the Notified Body to publish the list of their standard fees. This will be interesting to see whether you will be able to estimate the final cost and Annex VII requires to have all costs fixed in procedures for the different activities. How can a notified body know what resources it takes if the service was never applied! This only can mean high estimates of fees in the beginning and we only can hope that some of the prices communicated may drop in the near future upon the actual experience.   



There is a lot more to say. Be aware of the NB requirement in MDR Annex VII to be prepared for the new NB process.



The below is a screenshot from the Nando website.

Categories: News
Tags: MDR notified body

For risk class I manufacturer!

Warning: No additional  transition for risk class I products.  Products who are risk class I and stay of risk class I must fully comply to the MDR by May 2020.

Please consider the MDCG guidance Guidance Notes for Manufacturers of Class I Medical Devices cover.pdf - December 2019. It was recently published and is great outline of what needs to be done specifically for risk class I products (see also News & Views 2019.12.19). We guess we can call this THE EIGHT STEPS TO CLASS I CE MARK.



Indeed it does extract the important aspects and should get you in compliance quickly.

Categories: News
Tags: MDR class I medical devices
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