Category - IVDR

medicaldeviceslegal

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 me: people that say that the MDR or IVDR is ‘new’. In a way of course they are if you look at things […]

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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, the amendment now applies all throughout the Union as referenced in article 1 MDR and IVDR. Union as in not European Union, which […]

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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 them that watched the vote on the Parliament’s streaming services were surprised and disappointed that the vote seemed unclear: no vote on the […]

medicaldeviceslegal

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 them that watched the vote on the Parliament’s streaming services were surprised and disappointed that the vote seemed unclear: no vote on the […]

medicaldeviceslegal

MDR and IVDR outlook for 2023

What to expect for the MDR and IVDR in 2023? Predictions are very hard, especially if they are about the future. That’s a paraphrase of a very solid Danish nugget of wisdom attributed to the physicist and chemist Nils Bohr. But let’s see what we can do based on some basic extrapolation of things currently […]

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Focus on the authorised representative

Last week we saw publication of the new MDCG guidance on the authorised representative under the MDR and the IVDR, MDCG 2022-16. My first impression: much about the ‘what’ and not so much about the ‘how’, resulting in a guidance that, in typical MDCG fashion, repeats a lot of the law back at you without […]

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The 2nd edition of The Enriched MDR and IVDR is available now

It took a while, but here it is: the 2nd edition of The Enriched MDR and IVDR, updated with developments from early april 2021 to early September 2022. The first edition of the book was revised thoroughly, many new clauses in the MDR and IVDR were annotated and obsolete information was removed. New flowcharts and […]

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Verelendung is a process, people!

Over the summer holidays I (and perhaps some other people too) were in burning anticipation about announced measures to be adopted to deal with the MDR slowly moving to a big crunch or other equivalent astrophysical end state event at the end of the grace period. MDCG 2022-14 on Notified body capacity and availability of […]