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Eudamed delayed, but MDR not delayed – now what?

You may have already heard it from many directions: Eudamed is delayed with two years. Time to party now because you can shelve your MDR implementation project for two years and go back to do other things? Nope, unfortunately most probably not – read on. After some pretty mysterious statements of Commission officials in public […]



Trends from Silicon Valley for meat alternatives

What does the future of our meat look like? This topic was the subject of the Annual Conference of the Good Food Institute (GFI), which took place in San Francisco last month. GFI is an American non-profit organization that works with entrepreneurs, scientists and investors to make groundbreaking good food a reality. GFI focuses on […]


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More on the PRRC

I have written about the PRRC before, when the MDCG PRRC guidelines came out earlier this year. With more experience with the subject in the mean time and everybody working to understand…
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The Commission and the Council on the MDR state of affairs

The public part of the Employment, Social Policy, Health and Consumer Affairs Council meeting on last Monday, 9 December 2019 gave an interesting peek into how the Commission and the Council see…
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Corrigendum 2 and the (potential) consequences for class I devices

Everybody has been in enormous suspense about how the second corrigendum to the MDR and IVDR would turn out. The version that came out of the European Parliament’s ENVI committee vote contains…
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Article

Eudamed delayed, but MDR not delayed – now what?

You may have already heard it from many directions: Eudamed is delayed with two years. Time to party now because you can shelve your MDR implementation project for two years and go…
Read more

Article

Eudamed delayed, but MDR not delayed – now what?

You may have already heard it from many directions: Eudamed is delayed with two years. Time to party now because you can shelve your MDR implementation project for two years and go back to do other things? Nope, unfortunately most probably not – read on. After some pretty mysterious statements of Commission officials in public […]

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Counting down to the MDR date of application, and the legal stuff to get right before May 2020

Do you know that feeling that things look far away, but when you think about it are a lot closer than you think? This is the feeling that the first medical devices…
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Seminar MDR & IVDR Implementation Countdown – slides

191002-Erik Vollebregt-MDR Countdown 191002-Paul van Geffen- Last elements before implementation 191002-Sue Spencer – IVDR Executive summary 191002-Ronald Boumans- Latest on Eudamed

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Trends from Silicon Valley for meat alternatives

What does the future of our meat look like? This topic was the subject of the Annual Conference of the Good Food Institute (GFI), which took place in San Francisco last month. GFI is an American non-profit organization that works with entrepreneurs, scientists and investors to make groundbreaking good food a reality. GFI focuses on […]

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New sort of applicable economic operators regulation: the Market Surveillance Regulation

Attentive attendees of my presentations will have remarked in my presentations about economic operators that essential parts of the general Goods Package were being amended and that this may affect companies in…
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