Europe tables vote on tougher device regs

Instead of July 10, a committee will take up the matter on Sept. 18
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Legislators in the European Union have tabled a planned vote on tougher new medical device regulations, a strategic move meant to overcome a fierce divide that remains over planned changes.

Initially scheduled for July 10, the European Parliament's Environment, Public Health and Food Safety Committee's vote is now delayed until Sept. 18, Euroactiv reports, so committee members can hash out compromise amendments. The full EU parliament isn't scheduled to vote on the final regulations until November, however, and there will be rigorous negotiation before then.

In the wake of a scandal over substandard breast implants, momentum to reform EU medical device regulations had remained relatively strong. But as the story explains, the voting delay stems from a "political deadlock" over whether the revised regulations go too far, or haven't gone far enough. It's a risky move, in any case. A pause could give everyone time to reach a compromise, or provide opponents of regulatory change the time they need to successfully turn the tide in their favor.

Right now, EU member countries rely on certified organizations known as notified bodies to approve devices. And the European Commission wants these groups to have greater oversight. But the dispute involves whether proposed changes to create a U.S.-style centralized PMA approval process would go too far, stifling innovation and preventing devices from reaching the market in a timely fashion.

Medical device companies have come out in strong opposition to bringing a variation of the U.S. regulatory model to Europe. That's not surprising, considering that the EU system has long been faster and easier. Medical device companies from the U.S. and around the world often seek a CE mark first because that enables them to reach the market, generate revenue, produce more clinical data and better prepare for the more demanding and expensive FDA approval process.

Blame Poly Implant Prothèse for triggering this push for European regulatory change. The now-defunct French company sparked a scandal in 2011 when it acknowledged it had been selling breast implants with substandard silicone for years, leading to thousands of ruptures in the EU and Latin America. The company's executives now face jail time, following a public and dramatic trial earlier this spring.

- read the full story

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