What is a Significant Change for your Medical Device? with Erik Vollebregt
This is a topic that all of you are talking about. What is a Significant Change to your Medical Device?
I may say, it depends and this is also the answer of Erik Vollebregt who is my guest in this episode of the Podcast.
He will help us understand what you should consider a Significant Change and also provide some examples like for Software companies or also for a change of suppliers or finally during a Merger and Acquisition.
Why is this is so important? Because this would have an impact on your transition period. If you have an MDD certificate that expires after May 26, 2020, then you can benefit from a transition period where you can still supply your medical devices even if they have not transitioned to EU MDR.
But if your device is having a Significant Change during this period, then the transition period stops for it. It immediately falls under EU MDR. So it is important for Medical Device Manufacturers to understand this concept and plan a strategy for it.
After the recording of this episode, the MDCG finally released the guidance expected. I put the link below. This is based on some documents that we discussed during this episode. All that was covered in this episode is not changed due to this guidance.
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 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, Podcast, Online courses…
- Erik Vollebregt LinkedIn Profile: https://www.linkedin.com/in/erikvollebregt/
- Axon Lawyers website: https://axonlawyers.com
- Erik Vollebregt Blog on Significant Change: https://medicaldeviceslegal.com/2020/03/21/the-mdcg-guidance-on-significant-changes-a-significant-change/
- CAMD FAQ question – MDR Transitional provision: https://www.camd-europe.eu/wp-content/uploads/2018/05/FAQ_MDR_180117_V1.0-1.pdf
- LNE GMED guidance: http://www.lne-gmed.com/en/guides/free-guide-change-EC-framework.asp
- Medtech Europe – Joint Industry Position on Significant Changes according to MDR Article 120(3): https://wp.me/a9JvWo-TH
- MDCG 2020-3 Guidance significant change: https://ec.europa.eu/docsroom/documents/40301