Happy new year and welcome to 2019, a truly decisive year for the medical devices industry with interests in the EU. If you haven’t spent any time so far getting ahead of events relating to the MDR and IVDR, this is the year that reality will start catching up with you. This year will determine if a manufacturer goes up, or potentially out.
Why is 2019 so important? Read on, and you’ll agree with me that it is. First, take a look at the below diagram with the transition timelines, to which I hav [...] « Read the rest of this article on