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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 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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Developments and outlook re anti-kickback and corruption in the Dutch devices sector

, Erik Vollebregt Although no significant things happened in business compliance developments on a EU level for some time since Eucomed asked itself about guidance for sponsorship of conferences, things are very much in flux…
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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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More on advertising of medical devices – much more

, Erik Vollebregt As I have written before on this blog, medical devices are spectacularly unregulated by medical devices specific EU legislation when it comes to advertising and marketing. That does not mean however that…
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