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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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Managing the 2024 MDR danger zone – and outlines of a potential solution in MDCG 2022-11

We live in interesting times for medical devices in the Union – some have said we are headed for a cliff edge at the end of the grace period. I would personally…
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Article

Managing the 2024 MDR danger zone – and outlines of a potential solution in MDCG 2022-11

We live in interesting times for medical devices in the Union – some have said we are headed for a cliff edge at the end of the grace period. I would personally prefer to say that we are in the danger zone, which would be a zone of danger (Archer pun on Top Gun), but […]

Article

MDCG guidance as pseudo-legislation

The MDR has been applicable for some time and the IVDR just became applicable. The MDCG has, since both regulations entered into force, issued more guidance documents for the MDR and the…
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Article

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 […]

Article

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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