You will hear the acronym PRRC more and more as with the new Medical Device Regulation MDR 2017/745 and IVDR 2017/746 it is mandatory to have one at your company.

But what does it mean? This means Person Responsible for Regulatory Compliance. It will be a key person on your organization and you cannot appoint anybody at this role.

To help you understand what are the requirements, Erik Vollebregt from Axon Lawyers and myself will review with you the last guidance issued by MDCG. There is some clarification but there is still some unknown.

So, if you want to be compliant with the MDR, you need to listen to that.

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 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.”

• MDCG guidance 2019-7 : https://tinyurl.com/MDR-PRRC

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The post Episode 36 – How to choose your PRRC with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi