ENVI's 29 may debate on medical devices

ENVIThe 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 follow for those that have not attended the debate, watched the video feed or followed @maxwellmedtech tweeting directly from the scene. You can also download the video report (warning: that will take a while).


The developments in this respect are really interesting. Even Mrs Roth Behrendt herself does not seem to be completely vested in this option, saying that she will be looking for a ‘compromise on a technical level’. Mr Liese, the IVD regulation propel rapporteur, openly questioned the wisdom of setting up such a system. Many ENVI members that spoke said they did not believe in PMA, some said they do. One (Holger Kramer) hit the nail on the head by making the point that the case for PMA is not evidence based but more of a pursuit of personal belief of those involved. I completely agree, because there is no evidence base for PMA in medical devices as proposed in Mrs Roth Behrendt’s report. Her arguments would only be true if the market would be flooded with inherently unsafe devices as a result of faulty market access controls, which is just not true as a comparison between US and EU recalls has shown. Also, EMA has no experience in devices so it’s expertise in that field would need to be completely built up – a Herculean task in terms of financial and organisational issues, some other parliamentarians said (among others Mrs Taylor and Mr Liese).

And of course some theater

drb2There was some theater at end with Mrs Roth-Behrendt ending the session by accusing the medical devices industry of lying once more. She subsequently proceeded to attacking Mr Kramer directly for doubting her facts basis and proceeding to offering proof to support her statements, suggesting to me that such proof still remained to be collected before it can even be shown. Why sit on such golden evidence if you need to convince people, right? Why the suspense? We haven’t seen suspense like this since Colin Powell finally showed pictures in the UN Security Council that were supposed to prove the presence of weapons of mass destruction (“The photos that I am about to show you are sometimes hard for the average person to interpret, hard for me.”), saying he had facts, corroborated by many sources. And then there turned out not to be any WMDs. I’m just making the point that politics and facts do not always work together very well when large political goals and vested political interests are at stake, and that we should be wary of this getting in the way of solid fact based decisions decisions in the medical devices and IVD dossiers. Because the Commission, for its part, did check facts and underlined that they considered PMA as option in their impact assessment underlying the regulation proposal, and then decided against it because it would not solve the problems of the PIP scandal – while there was no reason to raise the bar on market access controls with PMA. So these facts are there and I would love to see if Mrs Roth-Behrend has better facts than the Commission.

Of course everybody agreed that the highest level of patient safety needed to be ensured, but nobody has been saying it shouldn’t.


Also there Mrs Roth Behrendt seemed to relent on the plan to turn the world upside down by making every device reprocessable unless proven otherwise (with a high burden of proof). She has difficulties with letting manufacturers ‘print their own money’ by means of single use labeling and it is not really clear in what direction the minds are going. A negative list of devices for reprocessing was coined, but I am not sure that this will get a lot of traction. In any event the Scandinavian countries were very much against reprocessing and were not convinced at all that this could be done safely for plastic products.

Notified bodies

The notified bodies were discussed in terms of the controls member states must exercise over them and the internal expertise that they should have. Some members made the – I think very valid – point that you cannot oblige notified bodies to have all the expertise employed all the time, because that way the best experts may not be available to notified bodies. The general consensus seemed to be that the Commission’s proposal is going in the right direction, but ENVI wants it to be stricter.

Everyone, including the Commission, agreed that member states must control their notified bodies stricter, notified bodies must be monitored more closely and that the competence criteria for notified bodies should go up. I think even the notified bodies themselves are getting used to that though and are bracing for impact for the shakedown that the regulation will bring about. Better start planning time slots a long time in advance at one of the survivors if you are a manufacturer.


More on that in a next post, but I should mention that most of the amendments further to the report came from Mrs Roth-Behrendt, as Mr Liese, the rapporteur responsible for the IVD proposal mentioned, which shows that she has made a promise to herself to put a firm stamp on that dossier too.


Is Mrs Roth Behrendt pursuing a clever political plan to seem to overshoot but land exactly where she wanted to in the first place? We will never know for certain, but it seems that the cooler minds are starting to influence where ENVI is going and what compromises may be reached with a view to the vote on 10 July. She also ended the session by saying that she wanted to comprise before the vote, as to not go into a controversial vote. I can only applaud that. She wants the dossier to progress and a large majority vote for the amendments, with a view to having the dossier signed, sealed and delivered early 2014. But, this may prove tougher than she thinks with MEPs saying “Lord knows what’ll happen during vote”.

Schermafbeelding 2013-05-29 om 21.43.18

The Commission expressed that they were happy with the way ENVI was moving this dossier forward and said it would be happy to provide all support necessary, also on technical matters.

I, for my part, think that the member states are the dark horse in this race and they will decide how cooperative they based on how much they like ENVI’s results from the vote. Remember, none of them except France even wants PMA – unless that changed in the mean time since the Danish presidency. That will take a lot of compromising.

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