EU medical devices directives revision: "The wings are not on fire"


The wings are not on fire!

Everybody (I would hope so for the sake of cultural standards) will be familiar with the famous Monty Python sketch about the two bored pilots that decide to make things interesting by causing panic with the passengers by means of a series of increasingly urgent and ill-considered messages over the airplane intercom.

This sketch almost seems to be a template for the ENVI committee’s process with respect to the medical devices directives revision. Dramatic statements, delayed vote, proposals for amendments that make no sense and/or go in all directions, companies panicking al over the place – all the ingredients are there. Humor aside: it would almost be funny if this was not about the rules that impact the actual lives of patients.

Currently we’re waiting for the 18 September vote (coming Wednesday) and while the ENVI committee is internally preparing its compromise and other amendments to be voted on, the rumors start to flow about what’s cooking. So, based on what I’ve heard I decided to fire up my crystal ball to give you some insight in where I think things might be going on some of the bigger points in the mix. Mind you, this is all highly speculative thinking about a very fluid situation happing in an intransparent stage of the political process.

Compromising? Rather: complicating.

The ENVI committee is now in its compromising process and things are getting more and more complex very quickly. I would not be surprised if MEPs are by now starting to give up on the process hoping that the Council will solve it, because the dossier is becoming too complex for everyone. The same happened with the General Data Protection Regulation that completely spun out of control in complexity and is now firmly bogged down in the committee responsible. I recall statements of rapporteur Roth-Behrendt to the effect that we should be happy that the experts of the Parliament are on the case to help the member states get the Commission’s proposal up to standards. That all sounds a lot less glamorous now. The rapporteur will of course blame everybody else for making it overcomplicated with their devious lobbying and even alleged lying, in a textbook exercise in cognitive bias that we have witnessed at work in the March 2013 workshop and the 29 May ENVI debate.

From what I have heard about the compromise amendments in the making this complexity will only get worse, because EU legislative compromising is about giving everybody just enough of a little something so each of them can claim success. The French have something like an agency sign off, Roth-Behrendt has the EMA (which she helped create) in the mix, the notified bodies stay involved, the member states have committees that play an important role and the Commission is the spider in the web, you can just draw the picture by connecting the dots of interests involved. That kind of process never leads to the best legislative solution, but inevitably to the most overcomplicated and unclear one. Neither will help, as we need legislation that is clear, precise and serves its own purpose. Not somebody else’s political purpose.

Fog of war, still or again

At this point it is impossible to say where things are going, this is fog of war again, or still is. The parliamentarians are in Strasbourg compromising like it’s 1999 and nobody from the outside has a reliable view into this black box. What I have heard is that the vote for the 18th will be based on grouping of the 900 plus amendments, the compromise amendments and the consolidated amendments from political fractions in the parliament into several options that the ENVI members can vote for. What the options are is not clear either at this point.

I think it’s safe to say that one of the options is some form of PMA somewhat along the lines as proposed by the rapporteur Roth-Behrendt in her proposal – a safe bet, because Eucomed launched a renewed attack on that option today which means that in their impression this option must clearly still be on the table and I have no reasons to second-guess them on this point.

Another possible option might be the rumor I heard about the possible creation of a new class of ‘super notified bodies’ under the supervision of EMA. These super notified bodies (I hope they will get spectacular uniforms and logos) would be allowed to certify riskier devices than the other, ‘normal’ notified bodies. Why on earth submit this to EMA supervision? Well, that’s compromise in action for you, since EMA probably doesn’t even want this job or has personnel qualified for it – medicines are rather different animals than devices.

Option 3 could be to basically leave the system of notified bodies as it is, but give the Commission a role in the accreditation of notified bodies (I’m speculating here, but I believe this was in one of the many amendments) to ensure uniform quality. Not a bad idea, but a hard sell to the member states that would get power taken away from them.

Option 4 might be to leave things as they are but increase the member states surveillance over notified bodies (as is currently going on in the Joint Immediate Action Plan). That would fit in what the member states would like, as they have already said they won’t like transfer of power to the Commission or EMA.

There may be more options. As said, I have no idea about whether these thoughts is remotely right and whether other options are on the table, but this is what I can conceive based on what I have seen in the process so far. Also, I have not even begun to speculate how the Roth-Behrendt proposals on reprocessing of medical devices fit into these options or what may happen to all the crazy proposals around genetic testing in the IVD amendments.

Let’s not lose it

You know how that Monty Python sketch ends, right? Everyone jumps out of the airplane in blind panic and the pilots stay behind puzzled why on earth that happened. Well, to continue the analogy: the same happens if you prepare to impose rules that don’t make sense in a situation that calls for rules that actually work, and then hold that over the market for a couple of years, expecting that nobody is paying attention and that you don’t influence decisions of companies about where to go with their innovative medical device first. Expecting that this does not have a detrimental effect one way or the other is somewhat naive. Seriously, having innovative medical devices companies bail on the EU is not what we wish for the EU market for medical devices. We have been doing so well in Europe compared to other markets in terms of safety and time to market even if we got some things wrong that need fixing – let’s not waste this perfectly good crisis by adopting legislation that jeopardizes the advantages that Eucomed has described so well in their Don’t lose the 3 campaign, just because we need a compromise to appease people with proposals that were never a good idea from the start.

Maybe I’m too early with my criticism and maybe 18 September produces a brilliant result. But I’m hedging my bets and am starting to hope that the Council weighs in and channels these proposals into something workable, sooner rather than later.

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