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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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The new Commission eHealth Action Plan, and some thoughts on what it will mean for devices

, Erik Vollebregt Last week the Commission launched its new eHealth Plan (EHAP). It was announced under the header “Putting patients in the driving seat: A digital future for healthcare”. A nice rundown of the…
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More on internet sales of medical devices

, Erik Vollebregt With the Ker-Optika judgment that I wrote about before in relation to internet sales of medical devices and online sale of eHealth services the European Court (ECJ) set boundaries for national legislation…
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Consequences of the EU Ker-Optika case for eHealth services

, Erik Vollebregt In a previous post I have analysed the consequences of the European Court of Justice’s Ker-Optika judgment for e-commerce in physical medical devices. This post extrapolates the reasoning of the European Court…
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