revision

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EU Council also thinks genetic testing amendment in IVD regulation proposal is outside competence EU

In a previous blog I have addressed the genetic testing amendment to the IVD regulation proposal and have provided argumentation why this proposal is outside the scope of the legislative competence of…

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Where are we with the MDR and IVDR after the Greek Presidency?

Some time ago I promised you a follow up on the 20 June Council meeting, but I also mentioned that it could wait for a while at the time because the outcome…

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The genetic testing amendment in the IVDR

The focus of the EU revision of medical devices regulation is fully on the medical devices regulation. The revision of the IVD directive is sort of happening in the background and is…

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BSI white paper on EU medical devices revision

Are you still with me on where we are with the EU revision of medical devices and IVD legislation? If you are, you have strong tolerances for fast moving complexity – congratulations!…

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2 April 1st reading vote: what's next for the MDR and IVDR?

We had the first reading vote by the European Parliament on 2 April. Let’s put it in perspective. The previous last important iterations in the legislative process are the EP’s plenary vote on…

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EU Council to meet on Tuesday on MDR and IVDR proposals

This Tuesday morning 10 December the EU Council will meet to discuss the dossier of medical devices and IVDs revision for the last time during the Lithuanian Presidency, from 10:00 to 12:00….

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EU medical devices revision: counting down to the plenary vote

That’s right: it’s 10 minutes to midnight for EU medical devices regulation in the cold war between the ENVI committee and the industry with the upcoming vote in the European parliament’s plenary…

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Legal recourse against delegated and implementing acts in the medical devices regulation

This time I’d like to entertain you with some aspects of some of the dryest matter that I work with as lawyer: technical rules regarding competence and standing under EU law. However,…

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ENVI vote postponed once more

Compromising is time consuming business, that’s for sure. And sometimes it’s not easy to reach compromises. Apparently the ENVI Committee members were not able to reach compromises timely, because the postponed vote…

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