Class I Medical Devices under MDR with Erik Vollebregt (PART 2)
In this second part of the discussion with Erik Vollebregt, we will continue to help Medical Device manufacturers regarding the MDR Corrigendum 2. But we will also include more information about pure Class I devices.
The manufacturers with only class I devices will be surprised as there are also more requirements they have to follow per MDR. For example the creation of a QMS, the registration of economic operators, UDI…
So you should really understand those requirements as this can also increase the cost. I used the example of someone contacting me from the US to register an FDA class 1 product in EUROPE. And when I listen to him all the requirements and the cost of it, he was really surprised.
Learn to remain compliant just by listening to this episode.
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.”
Link to the episode
- Episode 53: https://podcast.easymedicaldevice.com/53
- Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt/
- Axon Lawyer Website: https://www.axonlawyers.com/
- Slide Presentation: https://www.slideshare.net/ErikVollebregt/mdr-and-class-i-medical-devices-presentation-203092176
- CEN/TR 17223:2018 MDR vs ISO 13485: http://tidd.ly/830baa
- Blog post on Corrigendum 2 (Erik Vollebregt): https://medicaldeviceslegal.com/2019/12/09/corrigendum-2-and-the-potential-consequences-for-class-i-devices/
- Corrigendum 2 link: https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf
- Class I technical file template: https://school.easymedicaldevice.com/shop
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