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Erik Vollebregt
Yes we can! We have a general approach for both the Medical Devices Regulation and for the IVD Regulation, agreed in the EPSCO Council last Friday. The press release also conveniently bundles…
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Erik Vollebregt
Upon closer examination of the two texts for the MDR and IVDR it became clear that the scrutiny proposals in both regulations are actually identical (sorry for the earlier confusion). Accordingly, there are…
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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
With this post I would like to make good on a promise I made some time ago: that I would also do an analysis of the proposed IVD Regulation in more or…
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Erik Vollebregt
Well, the 26 February workshop is behind us. The expectations were high, but I think in the end the workshop turned out to be the dud I expected; some people I spoke…
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Erik Vollebregt
“S is for scrutiny, which we’re not sure about”, that would be more or less the take home message of the MedTech Forum in Brussels that I attended last week from Wednesday…