Is EU MDR extended? with Erik Vollebregt
On December 9th, 2022, the EU Commission made a proposal to extend the transition period of the EU MDR 2017/745. But some people think this is already done which is not the case.
There was also at the exact moment the publication of the MDCG 2022-18 on Article 97 used to continue placing devices on the market. To clarify all that I have invited Erik Vollebregt from Axon Lawyers to help us understand the situation.
Many things were said, so let’s now debunk all the rumors and provide you with some clear understanding.
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 devices-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]
- EPSCO Meeting article: https://medicaldeviceslegal.com/2022/12/11/the-epsco-meeting-and-beyond/
- Commission briefing note on EPSCO meeting: https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf
- MDCG 2022-18: https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-18_en.pdf
- Easy Medical Device Authorized Representative: https://easymedicaldevice.com/authorised-representative-and-importer/