Placing on the market

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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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Update on Commission reaction to ENVI resolution – no PMA proposal on the table

, Erik Vollebregt In my previous post on this topic I wrote that it looked like the Commission had changed tack to propose a pre-market authorisation (PMA) for medical devices after all. It turns out that…
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FDA draft guidance on mobile medical applications

, Erik Vollebregt On 21 July the FDA released Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications, a document that I think has great significance for the regulation of the EU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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EU Court judgment may add 6.5% customs tariff burden for parts/accessories of medical devices

, Erik Vollebregt And now for something completely different: customs tariffs. Dry stuff, but it makes all the difference for the price of the device. Indeed, ‘parts’ and/or ‘accessories’ under heading 9018 of the Combined…
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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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