Today was an interesting day for medical devices in Europe. We had the EU Parliament’s plenary debate on the medical devices and IVD regulation proposals, and the subsequent vote on the highly appropriate or potentially devasting (depending on who you ask for comments) ENVI committee proposals. You can watch the whole debate video here, the rather confusing vote video with the occasional procedural discussion here or get an executive summary from Amanda Maxwell’s tweets (@ClinicaAmanda).
Largely predictable debate
The debate was largely predictable. Rapporteur Roth-Behrendt, imbued with the fire of the righteous, set the tone by accusing industry of being hysteric in their reaction and said if they would only make good products they had nothing for fear from just four months of delay. It was all about more Sicherheit, and who can be against that? Well, actually everybody that is not impressed by that framing and is convinced that more complexity that does not address the problem produces a better result. The Commission for one, which had Commissioner Mimica explain once more that PIP had nothing to do with quality of rules as such and that unlike ENVI committee the Commission actually had done its fact finding homework. He cautioned against the system of approval proposed and the reprocessing proposal. He also cautioned to keep the system of clinical study regulation consistent with the pending clinical trial regulation proposal.
It is also strange that the whole idea of stricter rules and more security goes head first out of the window with the rapporteur’s arguments about reprocessing, which revolved around the position that single use labeling is “Realitätsfern”, German for ‘far from reality’ (I had trouble with the Parliament’s video feed so had to watch in the original languages, which reveals an otherwise hidden dimension of colourful language). I myself would say that piling risk on risk by allowing devices that are not designed to be reprocessed to be reprocessed is very very bad risk management indeed, but ‘stricter’ rules apparently don’t have to apply to extra risky activities.
Rapporteur Liese’s statement for the IVDs was more balanced and mainly concentrated on his favorite item of the requirement of mandatory consultation before application of a genetic test, which I still believe is likely overstepping the boundaries of EU competence to legislate in medical devices.
Empty chair policy
With Peter Liese, rapporteur for the IVD regulation proposal, it started to get interesting. Since his political career is attached to this dossier, he fired a first salvo of criticism in thin air at the bench where the Council representatives normally sit if they would not have been ostensibly absent by saying the Council should commit itself to this dossier and help it forward. Rapporteur Roth-Behrendt later added to this complaint by saying that the Council should have the courage to start the trilogue with Parliament so this dossier can move forward and make some progress. That’s all very nice, but the Council so far has been keeping its cards close to its chest and will not address this dossier amongst themselves officially before 10 December this year in the last stages of the Lithuanian presidency, and then its over to the Greek presidency to make this happen before the elections – or not. For the moment it seems that the Council may be voting with its feet by delaying the proposal and quietly run it into the ground by delaying until the elections in May 2014 happen. It will be interesting to see what the Council does: improve what is on the table or let it peter out. In the mean time the Council’s working groups looking at the medical devices and IVD revisions will continue work on the Parliamentary vote results.
The vote was pretty confusing, so I won’t draw firm conclusions on that before I have seen the official outcome. The Parliament’s press release is not much use because it doesn’t give any news on what was voted in and what out. From Eucomed we learn that the watered down case-by-case assessment of certain devices was adopted and the the reprocessing proposal has been tweaked by reversing the Realitätsfern idea to make all devices reprocessable by default but did not bring it back to the Commission’s original proposal. I assume Mrs Roth-Beherendt will be visiting patients that suffer complications from failing reprocessed single use devices in the future personally to inform them that they’ve suffered for the greater good. Also the rather superfluous hazardous substances phasing out requirement has made it through, regardless of the fact that the EU has perfectly good other regulations for hazardous substances in articles already in place, like RoHS and REACH.
The IVD industry was – it seems from EDMA’s press release – generally happy with all the novelty, expect for the shortening of the transitional period from five to three years, which they consider too short to generate the clinical evidence required under the new regime.
All in all
A mixed bag, as my UK colleagues would probably say. But definitely a bag that may still carry some surprises with the Council as the dark horse that I predicted it would turn out to be earlier this year.
Update 23 October
The vote results are in: you can download them here. I will proceed to analyze them – stay tuned.
Great piece Erik. The vote was indeed confusing, especially as regards to the Assessment Committee for Medical Devices (ACMD). Do you know what the outcome of the vote (in the 2 reports) meant for this committee?
Hi Daniel, I’m not sure as I do not exactly know yet which procedure was voted in and whether they made additional amendments. If we would operate under the assumption that it resembles amendment 374 and that this was adopted in some form, the ACMD stays involved as optionally consulted and perform a clinical assessment to be submitted to the MDCG. But, as said, we won’t know for certain until the results are out.