The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt
This week I had some exciting moment when I followed the EU parlement webcast on the April 17th, plenary session to see what they will decide about the proposal to delay the EU MDR until May 26th, 2021.
Already in the morning we had a first vote with some good result. And at the end of the day it was confirmed. The EU parliament adopted the proposal.
Now in this episode we will come back on the context and the consequences of this vote for the Medical Device Industry.
Erik Vollebregt and I followed these last weeks the situation and want now to provide you some answers as I get a lot of questions.
Some of the topics that we will discuss are the consequence to:
- Article 59 of the EU MDR and 54 of the EU IVDR
- Notified Body situation
- Brexit, Swixit and Turxit
- Economic Operators
- Annex XVI
Who is Erik Vollebregt?
Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, 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 of 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 for 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 specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
- Erik Vollebregt Linkedin profile: https://www.linkedin.com/in/erikvollebregt/
- Axon Lawyers website: https://axonlawyers.com
- Erik’s blog post on the parliament vote: MDR date of application move: politically a done deal now
- Proposal adopted document: https://www.europarl.europa.eu/doceo/document/TA-9-2020-0053_EN.pdf
- Council secretariat information note: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_7322_2020_INIT&from=EN
- A general overview of procedure for the amendment: https://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2020:144:FIN
- Parliament decides to postpone new requirements for Medical Devices: https://www.europarl.europa.eu/news/en/press-room/20200415IPR77113/parliament-decides-to-postpone-new-requirements-for-medical-devices
- Blog post: MDR amendment proposal Article 120(3) oversight set to be fixed by Council: https://medicaldeviceslegal.com/2020/04/08/mdr-amendment-proposal-article-120-3-oversight-set-to-be-fixed-by-council/
- Blog post: The MDR amendment proposal: more than meets the eye: https://medicaldeviceslegal.com/2020/04/04/the-mdr-amendment-proposal-more-than-meets-the-eye/
- Blog post- Commission working on a proposal to postpone MDR date of application for one year: https://medicaldeviceslegal.com/2020/03/25/commission-working-on-proposal-to-postpone-mdr-date-of-application-for-one-year/
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