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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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"Swedish Document" reloaded – a new boost for medical devices standalone software regulation

, Erik Vollebregt Sweden is a lovely and industrious country that takes engineering very seriously; the small Scandinavian country that we know from its boxy but good cars also builds its own fighter jets (pretty good…
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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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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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Regulating Medical Software and nothing new on the Recast

, Erik Vollebregt Today I attended the COCIR workshop Regulating Medical Software in Brussels, a very interesting event that brought a lot of new information to my attention and I had the opportunity to speak…
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FDA draft guidance on mobile medical applications

, Erik Vollebregt On 21 July the FDA released Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications, a document that I think has great significance for the regulation of the EU eHealth…
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The European Commission's blueprint for Intellectual Property Rights – what's in it for the medical devices industry?

, Erik Vollebregt The Commission has decided that the existing mix of European and national rules are no longer adapted and need to be modernised. As IP lawyer I welcome this initiative. Although I have…
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