Euro devicemakers balk at proposed approval process

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.

But that won't cut it, legislators say. In their recommendation to the European Commission, members of the parliament said the breast implant fallout "has shown a malfunctioning at European and national levels, notably a lack of cooperation (…), and a lack of traceability of raw material used for medical devices." In order to avoid another dangerous mishap, the EU needs standardized, pre-market authorization for "dangerous medical devices."

The EU will make a final decision on the proposal later this year, according to parliament. 

- here's the European Parliament's release
- check out Eucomed's reaction
- read MassDevice's take
- get more from Regulatory Focus

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