Europe Responds to Medical Device 'Crisis'

Jun 01, 2012

Back in February, European Union health minister John Dalli conceded that the EU regulatory framework for medical devices needs an overhaul to—as he coyly expressed it—"remedy certain weaknesses that have come to light." Looming large over these was the discovery of the fraudulent use of non-medical-grade silicone in breast implants manufactured by the Poly Implant Prothèse company in France. The risks spread anxiety among thousands of women who had received these implants; more recent reports of the premature disintegration of prosthetic hip joints intensified this concern among the general population.

The overall effect has been to erode still further the European public's faltering confidence in the regulatory system that is, in principle, guaranteeing their safety.

The European Commission called for "immediate actions," including tightened controls, increased surveillance, and moves to restore public confidence. It plans to present proposals for new EU regulations governing medical devices later this year, with the intention of creating "a more transparent regulatory system." The new rules will retain the "innovation-friendly character" and "cost-efficiency" of the current system, Dalli promised. But they will also "ensure that the rules are effectively enforced across the EU."



At the same time, the requirements concerning clinical evidence will be strengthened and clarified to demonstrate the safety and performance of a device. And improvements will be made to ensure timely and uniform action in the areas of vigilance and market surveillance.

Above all, the new rules will be directly binding on member states, eliminating the margin for maneuver that member states currently enjoy in interpreting the rules.

The European Union is currently handicapped because virtually all it can do in the legislative framework is urge member states to act at the national level. EU legislation exists, but it is national authorities who are responsible for ensuring "full and stringent implementation of the current legislation on medical devices," the commission pointed out. So the commission has been reduced to encouraging member states "to tighten controls, provide a better guarantee of the safety of medical devices, and to restore patient confidence in the law that protects them."

Dalli called on health ministers for "a joint plan of immediate measures," asking for their "full cooperation in beginning work without delay." But not a lot has happened since then. Things don't move that quickly in Brussels—particularly when the member states haven't agreed to give some powers to the European Union to make things happen. Often, national interests—or simple national inertia—triumph over even the best-intentioned Brussels-led initiatives.