Roth-Behrendt

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More movement – new rapporteur for MDR, same for IVDR

Finally things start moving again in EU medical devices regulation dossier: the new rapporteur for the Medical Devices Regulation was appointed, replacing Dagmar Roth-Behrendt. It’s Glenis Willmott The new rapporteur is UK MEP…

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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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The EU Council Debate on medical devices regulations: wheelbarrow of frogs

Well, we had the Council meeting last Tuesday on among other things Health, in which the medical devices regulation proposal was debated at quite a length. Where are we now and where are…

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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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EP debate on devices revision – largely predictable, some surprise

Today was an interesting day for medical devices in Europe. We had the EU Parliament’s plenary debate on the medical devices and IVD regulation proposals, and the subsequent vote on the highly…

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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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Actually, the wings are on fire – ENVI vote result worst of all worlds

Two weeks ago I made a prediction on some worst case scenarios that could come out of ENVI today. That turned out to be pretty accurate given what I know at this…

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EU medical devices directives revision: "The wings are not on fire"

Everybody (I would hope so for the sake of cultural standards) will be familiar with the famous Monty Python sketch about the two bored pilots that decide to make things interesting by…

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ENVI IVD Regulation proposal vote postponed as well

So far it may have looked like the IVD regulation proposal would be put to a vote in the ENVI committee on 10 July because unlike the explicit movement of the date…

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