How can GDPR impact Medical Devices with Erik Vollebregt

There were a lot of discussions about GDPR since its implementation in early 2018. But after a few years, some issues are happening and this may impact the Medical Device Industry.

The EU MDR 2017/745 articles 109 and 110 + EU IVDR 2017/746 articles 102 and 103 are talking about confidentiality and data protection. This means that medical device manufacturers should also follow GDPR.

Recently there was a judgment (SHREMS II) about data protection with Facebook. And even if Facebook’s act is not specifically related to Medical Devices, this judgment is impacting Medical Device companies.

In this podcast, I have invited our preferred lawyer Erik Vollebregt to help us understand the technical aspect of this judgment and what should Medical Device manufacturers do to continue to stay compliant.

Erik also prepared for you all the documents related to this judgment and the AXON lawyer Newsletter so you have all the details on hand. Download them from the links below.

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 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…


Podcast Episode - GDPR impact to medical devices with Erik Vollebregt from Axon Lawyers and Monir El Azzouzi from Easy Medical Device

4 Replies to “How can GDPR impact Medical Devices with Erik Vollebregt”

  1. Chris Elliott

    Very interesting talk, thank you. Two questions:
    – at 32.38 Eric mentioned (I think) a blog and an annex – do you have a link for this?
    – there was nothing about consent – how much of the protection may be waived with informed consent?



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