medicaldeviceslegal

We will have a “swift” procedure in ENVI – not

Here’s some EU legislative procedure fun: do you know the joke about the European Parliament committee that was going to compromise to have an unproblematic vote? – It didn’t!

Well, that was a silly lawyer joke to make as a segue to inform you that the ENVI committee is not going to vote on the huge pile of amendments to the medical devices regulation proposal on 10 July. Seriously, ENVI has postponed the vote until 18 September. This means that the plenary vote will move to November, the month in which it was scheduled by mistake initially before the date was corrected to September.

So why was the vote postponed? With the ENVI committee in full blackbox mode seeking compromises among itself to arrive at an unproblematic vote we can only guess. It seems that the fact free politics of Mrs Roth-Behrendt (the rapporteur that proposed stricter pre-market controls to remedy post-market problems) have caught up with her and compromises turned out not that easy to reach. Apparently cooler and more rational minds are starting to prevail in ENVI and realize solving market surveillance issues with premarket controls is too simplistic to be realistic. But, since the inner workings of ENVI are not public, I am giving you my best guess.

What is happening to the IVD proposal of rapporteur Liese? As far as I know this is still scheduled for a 10 July vote, although it has the same problematic stuff on PMA based on noveltly as criterion in it. It would be really strange if ENVI would abandon PMA in general devices but keep it in IVDs. The two proposals are very intertwined. The logical thing to happen would be that ENVI postpones the IVD proposal vote too.

Biting off more than a committee can chew seems to be en vogue these days in EU legislation that stands to cause major collateral damage in healthcare, like the General Data Protection Regulation (see here for explanation). After being faced with a whopping 3000+ amendments the LIBE committee also did not meet its vote deadline of 28 May, as well as a number of earlier deadlines, and as per today no new vote date was set.

We are now facing a summer of suspense about how the ENVI blackbox will fare compromise wise. Also, Mrs. Roth-Behrendt might not make it European Ombudsman as she is hoping to (she did not get a majority in the first round of votes in Parliament today), which means that she may be around for longer to help create uncontroversial quality legislation for the medical devices industry.