Compromising is time consuming business, that’s for sure. And sometimes it’s not easy to reach compromises. Apparently the ENVI Committee members were not able to reach compromises timely, because the postponed vote on the medical devices regulation proposals that was scheduled for 18 September has now been … postponed, again. The discussion of the regulation […]
The fog of war that I wrote about with respect to the tsunami of amendments is lifting with the discussion of the amendments in the ENVI committee today. It was a very interesting debate, and I’ll share my impression of it with you. I have grouped what I heard by subjects so it’s easier to […]
That’s a good term to describe a situation of limited situaltional awareness resulting from many things happening at the same time very quickly, and a good term to decribe the situation we are currently in with the medical devices and IVD regulation proposals and the amendments proposed. Tsunami of amendments The period for tabling amendments […]
Well, the long awaited DRB (Dagmar Roth-Behrendt) report is here. I read through it as quickly as I could, answered a bunch of press questions and can now give you my preliminary view. I have poked fun at the process before with the ostrich picture but having read the proposal I am feeling more cynical […]
Well, the 26 February workshop is behind us. The expectations were high, but I think in the end the workshop turned out to be the dud I expected; some people I spoke with rather called it a theatrical sizzle or a dud with some drama. A nice factual and chronological overview can be found in […]
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 […]
In my previous post on this topic I wrote that it looked like the Commission had changed tack to propose a pre-market authorisation (PMA) for medical devices after all. It turns out that I had drawn that conclusion prematurely. This post serves to update and correct the picture. As more information became available after the hearing […]
Some time ago I wrote about the proposed ENVI resolution that the the EU Parliament’s ENVI committee adopted in reaction to the PIP breast implants scandal in the EU. At that time the final text was not out because the EU Parliament still had to vote on it. Now it has and the adopted resolution does […]