The IVDR text that the Council, Commission and Parliament reached agreement on is finally public (since 15 June). I’ve had the time to read it now.
I am not going to draft a long summarizing article that describes the IVDR in detail. For that I refer you to the new BSI white paper on the IVDR that was just published and that I co-authored with Gert Bos. This white paper provides an overview and to-do list for manufacturers on a chapter by chapter basis, like the one on the MDR published earlier this [...] « Read the rest of this article on