This month the European Commission will release its updated medical device review guidelines, with some lauding a win for regulatory oversight while others lament the inevitable delays for devices vying for market access.
The new proposal aims to fullfil a European Parliament request for more stringent medtech scrutiny by bolstering an existing pre-market review system with additional checks and more transparency.
The EU already has a mechanism in place for pre-market review of high-risk devices, but the new proposal would grant member states the ability to analyze and comment on assessments performed by Parliament’s Notified Bodies.
The new rules were spurred by a recent breast implant scandal that rippled through the continent. The European Parliament in June 2011 voted in favor of a new PMA process after French breast implant company Poly Implant Prosthèse was forced to recall 30,000 sets of breast implants after regulators discovered they were filled with substandard silicone.
Compounded with the ongoing controversy over metal-on-metal hip implants, the recent ruckus over faulty medical devices left European regulators at the center of public outcry.
Europe’s CE Mark medical device review is "a smokescreen for faulty and dangerous devices that place patients at risk," patient safety expert Brian Toft told regulators during a meeting with U.K. health minister Simon Burns in September 2011.
During the European Society of Cardiology meeting in Paris last August, physicians called the CE Mark pathway too lax in review of potentially dangerous products.
The European system is often cited as an example of how the FDA’s medtech review process might be faster and more efficient, but doctors at the ESC conference had harsh words for the CE Mark process, saying it uses the same structure to review pacemakers and electric toasters.
"Where there have been isolated instances of devices that were associated with complications, those have disproportionately occurred in countries that have earlier approval – and that tends to be Europe," Cardiff University cardiologist Dr. Alan Fraser, who led a E.U. regulatory review panel at the ESC meeting, told reporters at the time.
Voices on the other end of the issue worry that more stringent oversight may delay medical device review, thus slowing new products from reaching the market and patients in need of the life-saving technologies.
"Increasing the delay for some devices by augmenting traditional review with the scrutiny mechanism could change this paradigm – for the worse," according to European medical device lobbying group Eucomed. "Implementation of policies similar to the FDA’s PMA process puts the European marketplace for medical devices at risk for decreased innovation and reduced patient access to novel technologies."