Breaking News: EU MDR Extension Proposal is out for consultation
Finally, a proposal is now available, and we wanted to discuss it and identify if there are any surprises. Erik Vollebregt from Axon Lawyer is helping us understand all this.
This proposal is also under consultation until January 18th, 2023. So don’t miss that as this is tomorrow for those seeing the episode today.
To conclude, this is only a proposal, so this is not approved. We are still waiting for the vote. Without this vote nothing is real.
Who is Erik Vollebregt?
Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and the protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical device-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video
- Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt
- Axon Lawyers: https://www.axonlawyers.com/
- Book EU MDR: https://medicaldeviceslegal.com/2022/10/27/the-2nd-edition-of-the-enriched-mdr-and-ivdr-is-available-now/ [COUPON CODE: easymedicaldevice10]
- Download Decision Tree: https://podcast.easymedicaldevice.com/wp-content/uploads/2023/01/MDR-amendment-flowchart2.pdf
- EPSCO Meeting article: https://medicaldeviceslegal.com/2022/12/11/the-epsco-meeting-and-beyond/
- Consultation link: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Extension-of-the-transition-period-for-medical-devices_en
- Commission proposal: https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf
2 Replies to “Breaking News: EU MDR Extension Proposal is out for consultation”
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These podcasts are always very informative thank you! I was hoping perhaps on the next one it would be helpful if you are able to address what this EC cert extension would mean to those manufacturers that have decided to selectively upgrade products to MDR. In other words due to the up-classification of certain devices my company has decided not to pursue MDR for those specific devices. However we meet the conditions of the proposal: have a signed agreement with a NB, an application, and submitted 4 tech files back in July for the first review. Since the plan is not to re-issue certs I am curious if the validity of the MDD cert extends to the devices that we do not intend to pursue MDR. I can’t be the only manufacturer out there with this query. Thank you!
Hi Nancy, thanks for your message. Regarding your question, the signature of the agreement should be on the devices that will be renewed. If your certificate is till not expired you should update your agreement with the NB to include these products otherwise you cannot legally extend them with the new law that will be issued.