Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1)
There are some changes to some Class I devices. But at the time of this episode, there is still 1 vote remaining before acceptance of the Corrigendum.
Following the release of Corrigendum 2 of the Medical Device Regulation MDR 2017/745 and IVDR 2017/746, there is a significative change related to Medical Device class I that is up classified.
In this first part of this podcast episode, I have invited Erik Vollebregt to clarify the situation and help us understand the consequences of this corrigendum.
If you are a class I manufacturer, you need to look at that as there will be a lot of information that can help you. There are also a lot of consequences if you are not compliant, even RETROSPECTIVELY.
In part 2 of this podcast that will be published the following week, we will focus on pure Class I devices. Medical Device manufacturers should follow EU MDR 2017/745 from May 26th, 2020 and we are trying to help you understand the situation.
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.”
Links
- 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
- 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
4 Replies to “Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1)”
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Thank you for a great podcast. Very informative. As a company we have struggled with finding a notified body to audit our MDR. Being up classed to IIa was proving to be a disaster by both trying to find an auditor and financial implication. We hope that we are given a few more years to up class! Looking forward to the vote next week and fingers crossed the extension happens as if it does not there will be a lot of products taken off the market.
Thanks shannon for your feedback. I really hope there will be no issue during the vote as I understand your situation. The Notified Bodies accreditation seems to be a difficult process and this can really penalize good manufacturers. Let me know if you need any support.
Thank you Monir!
I look forward to your next podcast! Please keep us posted on the outcome. All the best.
Thank you Sir Monir for detailed presentation on Class 1 Medical Devices. Class I Manufacturers of Class 1 Medical Devices were much happy that they have been over sighted from new MDR, but ultimately they have to play their part for manufacturing and placing their devices in European Market. They have to show extreme professional skill for manufacturing of Class I Medical Devices.
It is most relevant to our manufacturers of Medical Devices (Class Ir & Is) in Pakistan.
Sir waiting for your Part 2 on Class I Medical Devices.