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Multilingual chorus of disapproval for EU high-risk plans in devices Regulation

This article was originally published in Clinica

Executive Summary

The camp of the “MDR discontented”, those largely non-industry representatives who feel that the European Commission has not gone far enough in the Medical Device Regulation (MDR) proposals that would place high-risk device submissions under additional scrutiny, is becoming more vocal.

After the French competent authority, ANSM, was asked by its parliament to suggest ways of strengthening patient safety in view of perceived (and actual) weaknesses in the current EU device legislative code, German stakeholders, too, have been upping the ante.

The French proposed actions, contained in a report to parliament in September but only recently made public (presumably to leave enough room to digest the Commission’s own efforts that were released on 26 September), are brave, audacious and potentially structural in the change they could force on the beleaguered EU conformity assessment system.

They amount to a unilateral proposal to ignore, and redo, the work done on high-risk files by the vast majority of the notified bodies currently operating in Europe. ANSM will put its trust in only a small handful of notified bodies’ (NBs) work on high-risk files, it appears.

It seems a somewhat shocking move, but then again, is it? France comes with a history of strong decision-making in EU device regulation, and also is emerging from a hugely damaging episode in which ANSM’s predecessor (Afssaps) was found to be at grave fault in the pharma regulatory arena.

While it is still too early to gauge the fall-out from this news, which Clinica reported yesterday, it is clear that the high-risk scrutiny and NBs elements of the MDR proposal may get a rough ride in the European Parliament, even with MEPs mindful of aims for a mid-2013 first reading and May 2014 adoption.

The German criticisms are perhaps more predictable as to their source, but nonetheless are just as unwelcome for the European Commission legislators. The Commission must feel as if it has failed both ends of the debate – industry being at the other end – by scrupulously sticking to the middle ground.

Doris Pfeiffer, head of the German sickness funds’ central body, the GKV-Spitzenverband, recently posted hard-line calls for: an independent central authority for class III approvals; mandatory clinical trials as opposed to proof of equivalence to an existing product on the market; pre-announcement and publication of clinical trials plans in a publicly accessible European database; the facility for competent authorities to order long-term vigilance studies to establish side–effects post-launch; all adverse events (all classes) to be published and accessible; and an implant register to be set up. Implant manufacturers should have to take liability insurance as mandatory, she believes.

Industry finds her associated comments about legislation favouring industry above patients unhelpful.

Potentially of more help to industry is fact that the central association of medical technology producers, service providers and advisors (ZMT) will be among the group of associations that may be consulted on technical matters by the G-BA reimbursement authority. A decision confirming this was published in the Bundesanzeiger on 31 October. One of the ZMT’s first tasks will be to poll the medtech industry on the need for surveillance and registration of products, and on the proposed scrutiny mechanism in the conformity assessment process. The results will be collated and published in early January. BVMed, also part of this group, calls it “a first step in better participation on the JFC”.

Seemingly alone among EU member states, the UK recently issued a 10-week public consultation, via the MHRA, on the two Regulation proposals. The MHRA’s head of medical devices EU policy Graeme Tunbridge gave an eight-out-of-ten rating to the Commission’s proposal at an ABHI meeting on 17 October, three weeks after the proposal were released, which seems at odds with other certain other appraisals.

Indeed, his views on the scrutiny concept were that it might be difficult to achieve meaningful extra scrutiny pre-market – rather that it is better to do this in the post-market phase, when it becomes more an audit mechanism. At the other end of the scale industry objects to the mechanism on the grounds that it is overregulation, while conceding that the scope of the NBs must be addressed.

Despite the MHRA’s rational approach thus far, it seems that, 10 weeks into the normal legislative procedure, the gloves are really starting to come off.

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