Europe's Device Approval Process Could Become More Like FDA's

As the European Union moves to tighten its medtech regulatory process, some United States medical device manufacturers have expressed concern, warning that new regulations could impact funding and stymie patient access to lifesaving medical devices.The rehaul of the EU's regulatory process comes after a massive scandal involving poorly-manufactured French breast implants. In that scandal, PIP, an implant manufacturer, used industrial-grade silicon to create breast implants, leading to significant health issues and corrective surgeries in thousands of women.While avoiding occurrences like this is important, device manufacturers worry that the new rules will simply lead to delays without improving the safety of medical devices. On the 24th of September, the European Parliament's Committee for Environment, Public Health and Food Safety backed a more-stringent approval process for high-risk medical devices. Devices would be designated high-risk by the European Medicines Agencies.Since many companies rely on Europe as a first step in access to global markets, stringent regulations could impact a company's ability to commercialize its products. In particular, European post-commercialization data is used to bolster FDA 510(k) and PMA applications. According to Eucomed, a European device-industry group, medical device manufacturers can get their products approved in Europe several years earlier than in the United States."The bar is set artificially high in the U.S. If the rest of the world begins to raise the bar of approval to the U.S. level, it will surely damage investment in innovation and patient progress will plateau," noted Kevin Sidow, CEO of Moximed.A recent Eucomed survey, found that an FDA-style premarket authorization (PMA) system would cost more than $23 billion.