Devicemakers Must 'Act Now' on Objections to EU Device Regulations
Devicemakers that want their voices heard as the European Parliament considers reforms to medical device regulation need to speak up immediately, experts urge. The possibility of approval delays if a proposed premarket review system is adopted is likely to be one of Parliament's biggest qualms. . . .
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EU May Implement Device Directives Sooner Than Planned, Industry Warned
Manufacturers should brace for changes to European device regulations to be completed far sooner than the 2021 now indicated in official plans, experts indicated Wednesday at the MedCon 2013 meeting here. Paul Brooks, president of notified body BSI Product Services, said there are now significant lobbying efforts to start the transition in 2014. The length of the transition period is currently under debate as well, said Brooks, but could be as short as 18 months for the device regulation and 30 months for the in vitro diagnostic device regulation. . . .
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Fewer EU Notified Bodies Could Cost Manufacturers Thousands
A proposed plan to shrink the number of EU notified bodies could cost international devicemakers approximately $100,000 per manufacturing site, one expert says. "If you have a notified body, what happens when it is not on the list?" said Elizabeth George, vice president of global regulations and standards for Philips Healthcare. The European Commission is discussing consolidating the number of notified bodies from 78 to 25 or even 15, said Jürgen Stettin, CEO of Prosystem AG International Healthcare Consulting. . . .
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Industry Keeps Up Pressure Against Centralized EU Authorization
European devicemakers made clear their opposition to a centralized authorization system for high-risk medical devices during a recent public workshop, saying it would do little to ensure greater safety while delaying patient access to life-saving new technologies. The workshop, hosted by the European Parliament's Environment, Public Health and Food Safety Committee, was intended to gather feedback on the European Commission's proposed device regulations. . . .
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