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En salida, un empuje para reformar el proceso europeo de la aprobación del dispositivo

por Brendon Nafziger, DOTmed News Associate Editor | September 01, 2011
Europe's medical device approval process came under fire at the European Society of Cardiology meeting this week, with doctors calling for reform of the CE mark system which covers everything from home appliances to medical products, Reuters reports.

Europe's system is often envied by U.S. medical device manufacturers who say it's faster to get stuff approved -- one study found low- and moderate-risk devices got approved two years sooner in Europe. But some European doctors complain this seemingly smoother process -- which was created 20 years ago -- is troublesome.

"Standards of testing of medical devices are less rigorous in Europe than the U.S., where they have to undertake trials to show that the device has an impact on clinical outcomes, with the reality that European patients are currently exposed to an unfair proportion of the risks associated with developing new devices," Dr. Alan Fraser, a cardiologist at the University of Cardiff who chaired a policy conference for the ESC earlier this year, said in a May statement.

At the time, Fraser said to get a balloon angioplasty device approved in Europe, a manufacturer would need to show that it widened the artery or resembled other devices on the market, but would not have to present clinical outcomes.

Reform advocates also want to see a pan-European Union regulatory system. Currently, no centralized body approves devices, with critics fearing manufacturers shop around for EU countries with weaker regulations.

However, medical device manufacturers in the U.S. have previously said the European regulatory system wasn't any more dangerous than the centralized, slower American one, and wasn't associated with higher rates of products recalls. An industry-funded report, released in January, found both the U.S. and Europe averaged around 21 serious recalls a year.

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