Tougher EU Regulations Would Be Less Stringent than FDA Oversight

The European Parliament voiced support for tighter regulations of medical devices. While these regulations would strengthen the European Union's CE Mark system for medical devices, it wouldn't be as rigorous as the United States' pre-market approval system. In part, officials were concerned that a U.S.-like PMA system could significantly delay patient access to next-generation devices and treatments.

In 2011, a French breast implant manufacturer named Poly Implant Prothese (PIP) was involved in a massive scandal, which helped catalyze Europe's regulatory reform of how it handles medical devices. For approximately 10 years, the company manufactured breast implants using substandard non-medical-grade materials. As a result, thousands of women experienced severe health problems and required corrective surgeries. In an effort to prevent this from happening again, regulators are tightening up the EU regulatory system.

Voting on Tuesday in Strasbourg, the parliament backed plans for improved monitoring of medical device manufacturers. This could cover devices like pacemakers, heart valves, hip replacement and more. Manufacturers that could be impacted by the new regulations include Smith & Nephew, Allergan, Abbott, Boston Scientific, Medtronic and Johnson & Johnson.

As of now, there are approximately 80 notified bodies that help rule on certifications for medical devices. However, new regulations will force tougher certification standards on these bodies. For the most part, these bodies are private companies that national authorities use to conduct inspections of medical devices.