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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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Happy IVDR day!

Happy IVDR day my readers! My apologies for the low level of activity on this blog the last time. I’ve been very busy with MDR and IVDR work. And of course I…
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Article

More on placing on the market

After my blog about guidance document MDCG 2021-27 in which I argued why in my view it defines placing on the market wrongly by requiring transfer of a property right as a…
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Article

MDCG 2021-27 Q&A on importers and distributors – sort of box of chocolates

Life, as they say, is like a box of chocolates: you never know what you’re going to get. MDCG guidance documents are very much like that too. Even if you’ve seen them…
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Article

MDCG 2021-27 Q&A on importers and distributors – sort of box of chocolates

Life, as they say, is like a box of chocolates: you never know what you’re going to get. MDCG guidance documents are very much like that too. Even if you’ve seen them coming in the consultation phase the end result may still surprise you. Some are really good, some are really good and complex, some […]

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IVDR amendment proposal update: moving on up to adoption

I recently reported about the proposal to amend the IVDR immediately when it came out – please excuse the initial inaccuracies in the post on the subject of amendments to article 5…
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Proposal to manage IVDR

It had been been in the works for some time, although it also seemed unlikely for quite some time that this would happen. The implementation of the IVDR had been the slow…
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Article

Regulatory exclusivity rights: the General Court annulled the decision of EMA to not accept a marketing authorization application

On May 5 2021 the General Court published a (lengthy) judgement in which it annulled the decision of EMA to not validate (and thus not accept and review) a marketing authorization application…
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Article

Happy MDR DoA and Swixit / noTurkxit day!

As they say: this is the first day of the rest of your life, and in a way it is. The MDD is dead, long live the MDR! The (AI)MDD is no…
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