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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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ARTICLE

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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Article

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…
Read more

Article

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 […]

Article

StartLife Partners with Axon Lawyers to Support AgriFood Tech Startups in Navigating Legal Challenges

, Axon Admin StartLife welcomes Axon Lawyers to its network of partners, specializing in legal expertise within the Life Sciences sector. For StartLife, AXON Lawyers is committed to helping start-ups and scale-ups navigate the complex…
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Article

The German angle

, After having contributed to the improvement of medical devices legislation in many ways over the years (most recently by helping the European Parliament to come up with an initiative for targeted amendments…
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Article

Happy 26 May 2024!

, The MDR and IVDR are now in force for seven (7) years, and they are not in good shape. I think it is safe to say that they did not deliver on…
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Article

A case of so-called fiscal neutrality

, Sometimes you come across cases that violate Mandalorian Creed: “One does not speak unless one knows.”. This happened to me last week when I read the Dutch Supreme Court’s judgment in a…
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Article

Can we fix / improve the MDR and the IVDR?

, Or in other words that I’ve asked on this blog before: can the maker repair what he makes? This blog will argue that he can and he should. It still happens to…
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Article

MDR and IVDR amendment has entered into force now

, Today is the day that the amendment, aka the ‘extension’, to the MDR enters into force because it was published in the EU’s Official Journal today, number L080. As you are reading this,…
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But weren’t they supposed to vote on it on the 14th?

, Short update on the MDR amendment proposal because quite a lot of people were expecting the European Parliament to take a final vote on the MDR amendment proposal today. A lot of…
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