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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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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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EU Regulation on e-Labeling of Medical Devices expected to enter into force end this year

, Erik Vollebregt On 8 June the European Commission published a draft regulation on e-labeling as part of their WTO Technical Barriers Trade activities. Up to now, e-labelling was problematic and regulated in a fragmented way….
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