How to certify a self-testing device under IVDR? [Erik Vollebregt]

Medical Device made Easy Podcast

We have talked enough about EU MDR so this week we will help the IVD Companies with the requirements for Self-testing devices under IVDR. Self-tests or near-patient tests are problematic because they are used by laypersons which are not professionals on the way to use or interpret the result of such a device.

So, some particular care is provided by the regulators to verify that a layperson really understands how these device work and to avoid some misinterpretation.

Erik Vollebregt will be helping us to understand this situation and we will also talk about certain stories we were experimenting with.

Who is Erik Wollebregt?

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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links from the Video

• Erik Vollebregt LinkedIn Profile: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyers: http://www.axonlawyers.com/
• Presentation to download: https://mailchi.mp/easymedicaldevice/g5poc37919
• Episode 42 – New rules for the IVD industry with Maurizio Suppo: https://podcast.easymedicaldevice.com/42/

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