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In the first part of this podcast episode, I invited Erik Vollebregt to clarify the situation and help us understand the implications of this rectification.
If you are a Class I manufacturer, you should look at that because there is a lot of information that can help you. There are also a lot of consequences for not being compliant, even retroactively.
In the next part of this podcast we focus on pure Class I devices.
Manufacturers of medical devices must comply with EU MDR 2017/745 from 26 May 2020. We try to give you insight into the situation.
► Who is Erik Vollebregt?
Erik specialises in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and personal data protection. 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 an intellectual property and competition lawyer and started his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in litigation, commercial contracts and transactional work at three major international law firms.
He actively contributes to the development of legislation and policy at national and EU level through membership of specialist committees in industry associations and the European Commission. Erik also acts as an arbitrator in medical device disputes and is regularly called upon as an expert witness in foreign legal proceedings.
Erik has lived in Brussels and Stockholm for many years and speaks fluent Dutch, English, French, German and Swedish.
Chambers Europe 2017 about Erik:
He is known for his specialization in regulatory work, which includes medical technology, devices and products, as well as biotechnology. Clients attest to his strong capabilities, with one saying, "He stands out for me. When 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 issues. After working for many years in a large healthcare company, Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand medical device regulations worldwide. He has now founded the consulting company Easy Medical Device GmbH and developed many ways to share knowledge through videos, podcasts, online courses…
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► Links of the video
■ Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt/
■ Axon Lawyer website: https://www.axonlawyers.com/
■ Slide presentation: https://www.slideshare.net/ErikVollebregt/mdr-and-class-i-medical-devices-presentation-203092176
■ Blog post about Corrigendum 2 (Erik Vollebregt): https://medicaldeviceslegal.com/2019/12/09/corrigendum-2-and-the-potential-consequences-for-class-i-devices/
■ Corrigendum 2 link: https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf
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► Social media 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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#medtech #medicaldevice #compliance
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