Category - Recast


Happy New Year – with all those developments

The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year with lots of exciting developments ahead. This post will not be the usual regulatory and legal analysis of rules, but something more forward […]


Seminar on the new EU proposal on medical devices regulation

Dear readers, while I am working on the promised blog posts on parts of the new regulation proposal for medical devices, I would like to let you know about the two and a half hour afternoon seminar that my firm will organise this 14 November in cooperation with Philips Healthcare and the Qserve Group. As […]


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 […]