The new Blue Guide is out. So what are the changes for medical device manufacturers? Erik Vollebregt will give us his analysis and also some revelations on the Swiss MRA process if you still need the situation in Switzerland.

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Who is Erik Vollebregt?

Erik specializes in European and national legal and regulatory issues related to medical devices, including e-health, m-health, software and personal data protection. He is an expert in life sciences regulation at European and Dutch levels, with a particular focus on contracts and regulatory disputes against competent authorities and mergers and acquisitions. Erik initially trained as an intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He then acquired experience in litigation, commercial contracts and transactional work within three large international law firms. He actively contributes to the development of law and policy at national and European levels by being a member of specialist committees within sectoral associations and the European Commission. Erik also works as an arbitrator in medical device disputes and is regularly retained as an expert witness in foreign litigation. Erik has 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 specialization in regulatory work, which covers technology, medical devices and products as well as biotechnology. Customers confirm its strong capabilities, with one saying “it stands out to me.” Every time I work with lawyers, he is the best, with a solid scientific background. He has the perfect combination of skills and experience.

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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 major healthcare companies including Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand medical device regulations around the world. He has now established the consultancy company Easy Medical Device GmbH and has developed many ways of transmitting his knowledge through videos, podcasts, online courses… The company also acts as an authorized representative for the EU, the United Kingdom and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers who need quality and regulatory assistance.

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Video links

Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt
Axon Lawyers: https://www.axonlawyers.com/
Blue Guide link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uriOJ:C:2022:247:TOC
Blue Guide Blog: 2022 Update: https://medicaldeviceslegal.com/2022/08/07/the-blue-guide-2022-update-new-elements-regarding-applicability-of-eu-law-on-products /

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Social networks to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

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#easymedicaldevice #medicaldevice #regulatorycompliance

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