New EU medical devices regulations proposals out – first impression: nothing unexpected but devil is in the details

Today was a big day with a half hour press conference by Commissioner Dalli (for Twitter summaries see here and here) to festively launch the two much anticipated EU medical devices regulation proposals (one for general medical devices, including active implantables, and one for IVDs). The generalities of the proposals, as you can read in the press release and the Commission’s communication on the subject, are not a surprise given what we already know. However, the devil is in the details a [...] « Read the rest of this article on medicaldeviceslegal »