IVDR, in-house developed tests and the state of MDR/IVDR implementation

In several posts on this blog I have discussed the severe impact that the IVDR will have on the IVD industry selling in the EU (just click on IVDR in the tag cloud on the bottom right of the page). My firm has organised multiple seminars and I have spoken about this on more conferences and occasions than I can remember. Yet, at the Molecular Diagnostics Europe conference this last week it turned out that at this stage still really only the big IVD companies really know something about the IVDR. Small and mi [...] « Read the rest of this article on medicaldeviceslegal »