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Article

More on placing on the market

18 Feb 2022, 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…

Article

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

29 Dec 2021, 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…

Article

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

28 Dec 2021, Erik Vollebregt

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

01 Dec 2021, 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

15 Oct 2021, 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…

Article

Happy MDR DoA and Swixit / noTurkxit day!

26 May 2021, 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…

Article

The Enriched MDR and IVDR – finally available

24 May 2021, Finally and just in time for the date of application of the MDR: here it is, the book that I’ve been working on for a long long time. It turns out that…

Article

The Enriched MDR and IVDR – finally available

24 May 2021, Erik Vollebregt

Finally and just in time for the date of application of the MDR: here it is, the book that I’ve been working on for a long long time. It turns out that writing books while having a more than full-time job running a law firm and being a busy lawyer is a bit of a […]