The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story.
Not the IVDR
This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even thinking about the IVDR at the moment, because it needs all its resources to keep the MDR on track. At the end the document mentions: “It is also vital, following the 26 May 2020, to focus on the implementation [...] « Read the rest of this article on