White smoke again! After a long summer following the partial general approach on 19 June in which there was not much to report the Council now reached a general approach on the MDD and IVDR on 5 October, endorsing its negotiating position on the medical devices and in vitro diagnostic medical devices draft Regulations. The […]
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 […]
As promised yesterday, here is a first impression of the IVD Regulation (IVDR) proposal that may lead to a general approach this Friday in the ESPCO Council. In this post I will try to not repeat what I have blogged about yesterday given the large amounts of overlap between the two regulation proposals. Where things […]
The two texts that will form the basis for the Council’s attempt to arrive at a general approach at the EPSCO Council meeting on 19 June that would allow it to start the trilogue have been published for the medical devices regulation proposal and for the IVD regulation proposal. Only part of the picture Unfortunately […]
To get unstuck or not to get unstuck, that is the question that hangs over the medical devices regulation dossier in the Council currently. EPSCO council 18/19 June With the Latvian presidency drawing to an end and the EPSCO council of 18/19 June in sight, the question is whether the Council will manage to come […]
To get unstuck or not to get unstuck, that is the question that hangs over the medical devices regulation dossier in the Council currently. EPSCO council 18/19 June With the Latvian presidency drawing to an end and the EPSCO council of 18/19 June in sight, the question is whether the Council will manage to come […]
To get unstuck or not to get unstuck, that is the question that hangs over the medical devices regulation dossier in the Council currently. EPSCO council 18/19 June With the Latvian presidency drawing to an end and the EPSCO council of 18/19 June in sight, the question is whether the Council will manage to come […]
Many people ask me these days “Hey Erik, what is the status of the revision? When will this thing finally complete?”. Well, that’s an interesting question I often ask myself too. Of course I have my crystal ball and some bits of information from here and there but that still allows me to speculate only. […]
So, it took a while but the devices have finally landed. During the EPSCO council of 1 December it was confirmed that the medical devices policy has indeed moved to DG ENTR. I have also heard Commission officials tasked with medical devices at DG SANCO say they are in transition now. It also became clear […]