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

Een bijdrage van Erik Vollebregt, Axon Lawyers.

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 and there are some significant changes in specific matters. For those not interested in details: see the ultra short summary by Reuters. For those that are interested in some gems already unearthed, check Robert van Boxtel’s timeline on twitter.

I hope you will forgive me that the below analysis is not comprehensive: the entire proposal for the general medical devices regulation alone is 194 pages and I am sure I have missed a few points. I won’t discuss the new IVD regulation proposal in this post, but I could establish that my earlier blog on what I expected it to be was pretty accurate and will discuss that at a later occasion.

I am planning to do a series of blogs to discuss distinct parts of the regulation, so this is just a first and very personal impression of what jumped out at me in the proposal for the general medical devices regulation (MDR).

In a nutshell the aim of the MDR is that supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance are significantly reinforced, whilst provisions ensuring transparency and traceability regarding devices are introduced. Eucomed is happy with it because much stays the same (no PMA) except for the scrutiny procedure (see below), but their worst fears may still come true in the legislative process that the proposal has now entered.

lees het gehele artikel hier.

With permission, CC-BY-SA medicaldeviceslegal.com.