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Happy 2025 – more churn for MDR and IVDR!

Erik Vollebregt

Happy new year everyone! I hope you had a good rest over the holidays because 2025 will be interesting. I am planning to revive this blog this year and hope to put new energy in it by making it more periodical with smaller bits of information and shorter analysis. You will still get my unique […]
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Impossible and Incredible And Yet Really Happened

Karin Verzijden What can we learn from the Impossible vs. Incredible case in the Netherlands? At the end May this year, the Court of The Hague rendered a remarkable judgment: at the request of Impossible Foods, Nestlé was banned from launching its INCREDIBLE BURGER in the EU. How is this possible? Impossible Foods is not even on […]
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Happy New Year – with all those developments

, Erik Vollebregt The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year…
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New EU rules for (active) medical devices utilising non-viable tissues of animal origin

, Erik Vollebregt While everybody is starting up again after the summer and had 26 September as first major horizon date in their head (the date on which the Commission has said it will publish…
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Update on Commission reaction to ENVI resolution – no PMA proposal on the table

, Erik Vollebregt In my previous post on this topic I wrote that it looked like the Commission had changed tack to propose a pre-market authorisation (PMA) for medical devices after all. It turns out that…
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It's official: the ENVI resolution is out in final version – EU Commission changes tack to propose PMA for devices

, Erik Vollebregt Some time ago I wrote about the proposed ENVI resolution that the the EU Parliament’s ENVI committee adopted in reaction to the PIP breast implants scandal in the EU. At that time…
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EU court AG concludes in borderline case – "intended use by nature"?

, Erik Vollebregt The Advocate General of the EU Court presented his conclusion today in one of the three medical devices borderline cases currently pending at the EU Court, C-219/11 Brain Products vs BioSemi. The…
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The new EU MEDDEV on stand-alone software as medical device

, Erik Vollebregt Some time ago I already gave you a look under the hood of it and now it is here, the new MEDDEV on stand alone software: an interesting document that provides a…
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New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance announced

, Erik Vollebregt The EU just released its first MEDDEV of a number that were agreed upon in the recent MDEG meeting. More are expected to trickle onto the Commission’s devices web pages in the coming…
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CE marking of apps: It Can Be Done and Here Is How

, Erik Vollebregt If there is one thing that I have learnt by now working with medical apps and medical device law is that physicians have little idea about rules for apps with medical functionality,…
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Standalone software regulated as medical device: a look under the hood of the draft MEDDEV

, Erik Vollebregt Sometimes you have to go far away to learn a lot about thing close to home and that is what happened to me at the RAPS Regulatory Convergence Conference that I am…
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