White smoke: we have a general approach for the medical devices and IVDs regulations

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…


More on scrutiny in the general approach proposals for medical devices and IVDs

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, thereĀ are…


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…


The IVD regulation proposal in a nutshell

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…


A dud with some drama – a report of the 26 February ENVI workshop

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…


MedTech Forum 2012: "S is for scrutiny, which we're not sure about"

“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…

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