U.S. medical-device manufacturers are looking anxiously across the Atlantic as the European Union prepares to tighten the process to approve new products, a step companies say will crimp their lifeline to funding and patients.
The EU’s overhaul is meant to close loopholes that allowed breast implants made with industrial-grade silicone to be implanted in thousands of women. Yet device makers say the new rules will delay approvals without increasing safety. The European Parliament’s Committee for Environment, Public Health and Food Safety today backed a tighter approval process for high-risk devices by experts designated by the European Medicines Agency, a spokesman said. The proposal will be the basis for negotiating with member states on final rules.