ENVITwo weeks ago I made a prediction on some worst case scenarios that could come out of ENVI today. That turned out to be pretty accurate given what I know at this moment about the outcome of ENVI’s vote. ENVI did today what only happens in your worst nightmare: take several compromises and mash that into a compromise of compromises that cannot possibly work effectively.


ENVI decided to propose a PMA-esque procedure involving special notified bodies that even lawyers have difficulty understanding, in an attempt to arrive at the compromise that gives everybody in the political process a little of something, and leaves patients and industry with nothing. Eucomed has a good description of what it will look like in their press release, so I won’t repeat it. I can only echo the sentiment.


ENVI itself thinks it did the world a favor, according to their press release. I don’t agree, vehemently so. Having several family members that depend for their lives on the very high risk implantable medical technology that will now be far slower to reach the market I feel overwhelmed and appalled by this cognitive bias in action.

Don’t forget the IVDs

With respect to the IVD regulation proposal the irrational scare around genetic testing that I discussed before got the better of ENVI, because the proposal of mandatory counseling before genetic testing has been adopted as well.


We can congratulate the reprocessing industry on their excellent lobby, because a slightly watered-down version of the reprocessing amendment was adopted too.

Other things

There is a lot more of course, but with the text of the adopted amendments not having been published yet I will follow up on that in subsequent blogs when I can confirm exactly what happened on the basis of public materials.

But for the moment

The wings are really on fire now. The Parliament’s plenary will vote on this during the 21 to 24 October session in Strasbourg. The Council has to find a way to deal with these proposals, so we can only hope now that the Council will see through this political circus and actually does what it is supposed to do: protect the patients and have workable rules for industry. This madness will set the medical technology market in the EU back years, only because some parliamentarians that don’t understand the regulatory system feel they need to score. Strong words, but this is my personal sentiment. These ENVI members will move on at some point, leaving us with a system that it is the worst of all worlds. So, engage everybody: talk to your parliamentarians, talk to your government representatives.

It really is two minutes to twelve to prevent a crash landing of the EU’s medical devices regulatory system that has served us so well, thanks to politicians that just could not improve the few things that actually needed fixing.