PMA

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ENVI vote postponed once more

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…

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ENVI's 29 may debate on medical devices

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…

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The fog of war following a tsunami of amendments

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…

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Hold on to your seat: ENVI's Dagmar Roth-Behrendt report is here

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…

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A dud with some drama – a report of the 26 February ENVI workshop

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…

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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,…

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Update on Commission reaction to ENVI resolution – no PMA proposal on the table

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…

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It's official: the ENVI resolution is out in final version – EU Commission changes tack to propose PMA for devices

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…

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