Vigilance

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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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Marketing surveillance shaping up pre-Review with Dutch Minister feedback to Dalli Action Plan

, Erik Vollebregt Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to…
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New EU guidance on medical devices vigilance reporting – more than meets the eye

, Erik Vollebregt The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7….
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Update on Eudamed and its implications for vigilance in the EU

, Erik Vollebregt This will be a very short post, because everything I could write down on the subject is in the interview I had with Ashley Yeo of Scrip Regulatory Affairs, that kindly consented…
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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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EU court rules on no-fault liability for medical services with medical devices

, Erik Vollebregt The judgment in the Centre hospitalier universitaire de Besançon v Thomas Dutrueux, Caisse primaire d’assurance maladie du Jura case that I wrote about earlier has been handed down by the EU Court on…
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Outlines of the medical devices Recast become more fixed with Council conclusions

, Erik Vollebregt Since the High Level Meeting end of March where the Commission outlined its plans for the Recast of the Medical Devices Directive and took stock of the feelings about it in the…
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