FierceMedicalDevices

June 18, 2012 | By Damian Garde

The European Parliament is proposing a sweeping change in the way devices reach the market in the European Union, a move that would institute the first continental, pre-market authorization system there.

On the heels of Europe’s faulty silicone breast implant scandal, legislators recommended expanding the EU’s safety measures for implantables, including greater traceability, registries of devices, more stringent safety inspections and pre-market authorization. And, as MassDevice reports and perhaps you’d imagine, the industry is none too pleased with the proposal.

Eucomed, an EU trade association for biotechs, says the changes would lead to “years of delay in the availability of medical technology solutions to European citizens,” adding that the continent would be better served by using its existing infrastructure to create an efficient system that doesn’t prolong approval…

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