AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]
If you are working in the development of Software, then this is maybe something that will be interesting for you. The EU is preparing legislation for Artificial Intelligence and we will talk with Erik Vollebregt about the potential compatibility with the EU MDR 2017/745 This new legislation is not focused on Medical Devices but on all software that may contain AI. So if you are impacted, learn what will maybe come within your scope soon.
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, and 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 in 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… Recently, Monir is becoming a partner of Scube Technologies for the creation of the eQMS Scube SmartEye specialized for Medical Device companies. Check the link below.
- Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt?miniProfileUrn=urn%3Ali%3Afs_miniProfile%3AACoAAACQIeoBwNcVRqemNbX4xB92OSXiqh6ax58&lipi=urn%3Ali%3Apage%3Ad_flagship3_search_srp_all%3BIfAX1Az4TkG6EaE1%2Bb%2BZ1g%3D%3D
- Axon Lawyers: https://www.axonlawyers.com/
- AI Act report: https://www.government.nl/documents/publications/2022/05/25/legal-analysis-european-legislative-proposal-draft-ai-act-and-mdr-ivdr
- AI Act original proposal: https://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2021/0206/COM_COM(2021)0206_EN.pdf
- Track progress AI Act: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2021/0106(COD)&l=en
- Axon Lawyers powerpoint presentation: https://podcast.easymedicaldevice.com/wp-content/uploads/2022/07/AI-and-devices-puzzel-MedTech-Summit.pptx
- AI Act amendment: https://podcast.easymedicaldevice.com/wp-content/uploads/2022/07/AI_Act_Ammendments_Drago_Tudorache_1655544378.pdf
- Compromise text AI Regulation: https://podcast.easymedicaldevice.com/wp-content/uploads/2022/07/Compromise-text-AI-Regulation-ST_14278_2021_INIT_en.pdf
- eQMS Scube SmartEye: https://scube-technologies.com/