Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2
On this new episode, we continue to discuss with Erik Vollebregt on the MDR and IVDR. This is the second part.
If you missed part 1, you should go to:
► https://podcast.easymedicaldevice.com/14/ https://podcast.easymedicaldevice.com/14/
On this part Erik is answering my questions on:
- New regulation for Small and Big companies
- Notified bodies reduction
- Brexit and consequences for Notified Bodies
- and also rule 11 for classification of software
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 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 national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as 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 about Erik:
He 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.”