EU committee backs tougher, U.S.-style device approval system

A European Parliament committee finally voted on proposed reforms to the region's medical device regulatory process. Industry insiders were likely apoplectic about the outcome: The group came out heavily on the side of a U.S.-style premarketing approval system for high-risk devices.

In a word: ouch. As Reuters reports, the Sept. 25 committee vote landed well beyond what the European Commission initially proposed, which included greater EU control over notified bodies and the launch of unannounced inspections. Notified bodies are independent organizations across Europe that approve most devices under a relatively quick timeframe. But the European Parliament's environment committee took a big step away from that 20-year-old system, choosing instead to back a stringent, centralized, premarket approval process similar to that of the U.S.

Under the proposal now at play, Europe would establish a PMA system controlled by the European Medicines Agency to handle high-risk devices such as hip replacements and artificial heart valves, Reuters explained.

These are changes the industry doesn't want. Lobbying groups including AdvaMed in the U.S. and Eucomed in Europe argue that the proposals would add unnecessary delays to the European process and harm smaller medical device companies. Eucomed in particular questioned whether the European Medicines Agency had the capacity to take on the new responsibilities.

Of course, the EU committee vote is not set in stone. Reuters points out that lawmakers added more than 900 amendments to the European Commission's initial proposal. And the full European Parliament will eventually take up a vote on the measure in the weeks ahead, with no guarantee of approval. Assuming the contentious government body signs off on the new rules, negotiations will commence with local European Union governments to finalize implementation, the story explains.

A scandal over substandard breast implants made by the now-defunct French company Poly Implant Prothèse sparked this whole regulatory reform movement. But the Sept. 25 vote suggests that attempts to contain the fallout to more measured changes may ultimately fall by the wayside.

- read the full Reuters story

Editor's Corner: At AdvaMed, European regulations are on many CEOs' minds