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EU MDR & IVDR Notified Body Situation with Erik Vollebregt

► Webpage: https://podcast.easymedicaldevice.com/33 As we are changing the Medical Device rules, we need to certify new Notified Bodies in Europe. With the new EU MDR 2017/745 and EU IVDR 2017/746, all Notified Body should apply for new accreditation. The Medical Device Regulation in Europe is changing and it puts our system in a really difficult situation But apparently, this new regulation is not so easy and many Notified Bodies decided to not apply first. Then we have Notified Bodies that applied but decided to Lay Down Service. So what are the consequences for Manufacturers that have a certificate with these Notified Bodies? What should they do to continue the business? Is there something the member states can do to help them? Erik Vollebregt, from Axon Lawyers, will help to answer those questions. He will tell you exactly what you should do and also what are the consequences for your business. We will also add Brexit on the equation to see if this can be worst. ------------------------------------------------------------------------------------------------------- ► 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 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 national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as 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 about Erik: He is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as 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 from the Video ■ Erik Vollebregt blog: https://medicaldeviceslegal.com ■ Linkedin Profil:   / erikvollebregt   ■ Twitter Meddevlegal:   / meddevlegal   ■ Axon Lawyers: https://www.axonlawyers.com/ ■ Previous episodes with Erik: https://podcast.easymedicaldevice.com/14 ■ Nando database for MDR 2017/745. ■ Dutch orphan procedure: https://www.igj.nl/zorgsectoren/medis... ■ French orphan procedure: https://ansm.sante.fr/var/ansm_site/s... ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Linkedin:   / melazzouzi   ■ Twitter:   / elazzouzim   ■ Pinterest:   / easymedicaldevice   ■ Instagram:   / easymedicaldevice   ------------------------------------------------------------------------------------------ #medtech #medicaldevice #compliance