Category - Recast

medicaldeviceslegal

The Council’s IVD regulation proposal for the general approach

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 […]

medicaldeviceslegal

Compromise texts for EU Council EPSCO meeting public

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 […]

medicaldeviceslegal

The devices have landed – and some promotion

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 […]