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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
The ENVI vote results that have already been hotly debated and opined upon are now finally out in the form of a draft European Parliament legislative resolution that the Parliament will vote…
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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
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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Erik Vollebregt
While everybody is focusing on the legislative process in the ENVI committee and (to a limited extent) on what the Council is doing, significant other developments are playing in the background. Joint…
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Erik Vollebregt
Here’s some EU legislative procedure fun: do you know the joke about the European Parliament committee that was going to compromise to have an unproblematic vote? – It didn’t! Well, that was…
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Erik Vollebregt
ENVI’s amendments, following those of IMCO have been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 –…