Medical Device Class I with the new MDR - Corrigendum 2 (PART 1 of 2) скачать в хорошем качестве

Medical Device Class I with the new MDR - Corrigendum 2 (PART 1 of 2)

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 are up classified. On 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. On the next part of this podcast, 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 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 about Erik: He 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... -------------------------------------------------------------------------------------------- ► Links from the Video ■ Erik Vollebregt Linkedin:   / erikvollebregt   ■ Axon Lawyer Website: https://www.axonlawyers.com/ ■ Slide Presentation: https://www.slideshare.net/ErikVolleb... ■ Blog Post on Corrigendum 2 (Erik Vollebregt): https://medicaldeviceslegal.com/2019/... ­■ Corrigendum 2 link: https://data.consilium.europa.eu/doc/... ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin:   / melazzouzi   ■ Twitter:   / elazzouzim   ■ Pinterest:   / easymedicaldevice   ■ Instagram:   / easymedicaldevice   ------------------------------------------------------------------------------------------ #medtech #medicaldevice #compliance