EC’s Proposed Scrutiny Procedure Will Not Improve Patient Safety but Could Harm Industry, Says Eucomed Chief Executive

September 27, 2012 – 4:23 pm

It’s been a long time coming. The first public consultation on the proposal for a European regulation on medical devices dates back to May 2008. After endless back-and-forth, abundant speculation on what the document might contain and the proverbial bump in the road that was the Pip breast implant scandal, the European Commission published its proposal on 26 September 2012. It encompasses a number of significant changes that tighten regulatory requirements, including stricter control of Notified Bodies and increased vigilance. Pan-European industry association Eucomed applauds these and many other aspects of the proposal that “strengthen our regulatory system,” says Eucomed Chief Executive Serge Bernasconi. But—and it’s a big but—the association has serious issues with the so-called scrutiny procedure, which it characterises as a move toward a centralised premarket authorisation system.

“Article 44 Mechanism for scrutiny of certain conformity assessments” would enable a Medical Device Coordination Group to review submissions and request clarifications. Medico-legal specialist Erik Vollebregt describes the process in greater detail here. The procedure has the potential to significantly lengthen the time it takes to bring a product to market in Europe.

“We don’t see the need for this extra layer of control, especially in light of all of the other recommendations that are in the proposal,” says Bernasconi. “Where is that extra need? We are sensitive to public concerns,” he adds, acknowledging the fact that this deviation from the “new approach” philosophy of the existing medical device directives is in direct response to the Pip breast implant scandal. “It places an extra burden on industry but does not improve patient safety,” he stresses. And it has the potential to really hurt small and medium size enterprises (SMEs), he adds.

The scrutiny procedure can add a minimum of six months to time to market. If the committee is not satisfied with the data that has been submitted, it can ask for additional clarification. “And you know what that could mean,” says Bernasconi. “What is the maximum amount of time it could take? I don’t know, and that is of great concern to us in an industry where the innovation lifecyle is 18 to 24 months.” Imagine an SME that has a file under scrutiny, he says. “Everything stops while it is under review. That company may have a competitor who is not under scrutiny and whose product gets to market faster because of this. We are afraid that this [uncertainty] could frighten investors from supporting SMEs in developing their innovations,” adds Bernasconi.

The proposal now goes to the European Council and European Parliament, which will produce a final counterproposal that is turned back over to the European Commission. “During this process it will be Eucomed’s responsibility to explain what we represent as an industry and how we contribute to the well-being of patients and healthcare systems,” says Bernasconi. “When they understand who we are, they better understand our position.”

Eucomed is engaging in this part of the debate with great confidence. “Will we achieve 100% of what we hope to accomplish? I don’t know,” says Bernasconi. “But we are completely confident that we can bring the Council and Parliament to a better understanding of our position.”

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