There seem to be a lot of misunderstandings in the market about the current status of the MDR. Some think it’s finished (it’s not, at least not formally) and there is a lot of insecurity about when it will enter into force. Currently the MDR and IVDR are in the process of translation. The trilogue […]
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 all the general approach texts. Although the Council statements by the member states during the meeting left a lot of question marks as to […]
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 two novelties. Largely the same First, things unexpectedly stay largely the same both under the MDR and IVDR: pre-market evaluation by a notified […]
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 moment about the outcome of ENVI’s vote. ENVI did today what only happens in your worst nightmare: take several compromises and mash that […]
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 less the same level of detail as I did for the proposed Medical Devices Regulation, so here we go. As a starting point, […]
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 with rather called it a theatrical sizzle or a dud with some drama. A nice factual and chronological overview can be found in […]
“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 to Friday. This conference is an ideal moment to take stock of the EU medtech industry. No wonder that everyone was there to […]