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 the final text was not out because the EU Parliament still had to vote on it. Now it has and the adopted resolution does not differ very much from what we expected based on the ENVI Committee’s press release, so I won’t repeat myself in any detail.

As I wrote, the Parliament has given the Commission a shot across the bow and the unexpected (at least for me) happened. The Commission has changed its course now as a result and seems to have given in to political pressure to include the P-word (PMA, Pre-Market Authorisation) so it will include some form of PMA in the proposal, says Eucomed. The question that is open is if the Commission will propose a PMA system for risk classes IIb and III (as the Parliament would like, see point 7 of the resolution). The jury is not out on that yet, although the proposal would apply to “high-risk” devices. This is certainly a big change as the Commission was still saying in March this year that it would not consider PMA for medical devices. Now the proposal (which is expected in September this year) will be more interesting than ever, especially for companies with devices in class IIb and higher that have not been cleared for market access yet. It is a big departure from what many were expecting.

I would expect this development to spark off a run on the notified bodies by companies trying to get their high risk devices to the market before the new regulation will enter into force, which is currently expected 2015-2o16. If I were these companies, I’d make sure to have a slot booked at my notified body of choice as they will be running out of available slots very quickly now. You would hope the Commission would include a thought out transitional regime in the proposal, but better not count on that to happen.

Also, I am very curious where the Commission will find the resources for setting up a PMA system and how it will manage. As I wrote, nobody has money or resources for it, so I expect the proposal to be a creative balancing act – likely a procedure at a notified body with increased member state oversight and member state final sign-off on the notified body’s work before a high risk device (whatever that will turn out to be) may be made available on the EU market. This would be the only way I can think of to make this work. The only other way would be to make the industry pay for the PMA system as much as possible via user fees. This does not seem to be on the table yet – otherwise Eucomed would be a lot less supportive in its press release about the Commission’s plan to include PMA in the new regulation (“Industry would be supportive of such a mechanisms provided it proves to enhance patient safety and would not slow down the approval process of medical devices.”).

So, I’d really like to be able to tell you more at this point – but am very sorry I can’t for the moment. I will however keep watching developments closely and blog whenever there are developments to report.


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