Authorised representative


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Happy 2025 – more churn for MDR and IVDR!

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 […]



Impossible and Incredible And Yet Really Happened

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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New MEDDEV on authorised representatives: everything you know is wrong

Last week the Commission released a new MEDDEV guidance document on authorised representative as part of the package announced at the beginning of this year and this one is disruptive, especially if…
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