How does the EU Commission plan to save IVDR 2017/746?
A few weeks ago, we were surprised to hear that the EU Commission issued a proposal to delay some products from applying IVDR 2017/746 by my 26th, 2022.
So we decided to discuss this proposal with Erik Vollebregt and see how this should be interpreted as this is not a postponement that is proposed but more some phase application per product class.
Erik presented also during this session a diagram that he has made. I asked him to be able to provide that to you so check the links below to find it.
You can also read more of this proposal on Erik’s blog. The link is also below.
Who is Erik Vollebregt?
Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and personal data protection. He is an expert in life sciences regulation at the EU and Dutch levels, 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 specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies 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 now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, Online courses…
Links
- Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/
- Axon Lawyers: https://www.axonlawyers.com/
- Erik’s blog: https://medicaldevicelegals.com
- PDF – IVDR 2017/746 transition Erik Vollebregt: https://podcast.easymedicaldevice.com/wp-content/uploads/2021/10/Podcast-151-IVDR-grace-periods-Erik-Vollebregt.pdf
- IVDR 2017/746 EU Proposal: https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/md_2017-746-regulation_2021-amendment_en.pdf
One Reply to “How does the EU Commission plan to save IVDR 2017/746?”
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I would be very interested in hearing more regarding the aspect regarding Laboratory Developed Tests. It is much larger than just in “hospital laboratories” as it is also in public and private laboratories outside of the hospital footprint in many areas. As technology advances there are more and more tests developed or modified for diagnostic purposes.