Regulatory ProcessCalled into Question For the most part, the conference resembled the consensus-

Regulatory ProcessCalled into Question

For the most part, the conference resembled the consensus-building instrument it was meant to be. But one presentation by the European Society of Cardiology raised more than a few eyebrows among attendees. Alan Fraser, M.D., a board member of the European Society of Cardiology, claimed the EU’s regulatory system for medical devices is too lax; he used clinical evidence of inadequate premarket review processes for some Class III heart valves and stents to back up his claim. Fraser highlighted a few cases that turned into scathing indictments of the system—mainly devices that had obtained CE marking and then were withdrawn from the market for reasons that should have been detected in the Notified Body review. He recommended greater prioritization of clinical safety, more premarket testing and more clinical evaluations prior to approving high-risk devices.

EU regulatory representatives (not to mention medical device manufacturers specializing in cardiac applications) reacted with great displeasure but acknowledged some of the weaknesses in the current regulatory system.