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 less the same level of detail as I did for the proposed Medical Devices Regulation, so here we go. As a starting point, you should keep in mind that the Medical Devices Regulation and IVD Regulation proposals overlap to the point that the Commission has seriously considered merging them into one regulation, but in the end refrained from doing after considerab [...] « Read the rest of this article on medicaldeviceslegal »