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

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