Industry swats EU proposal for U.S.-style device regulation

A European Union proposal to establish a U.S.-style centralized approval process for medical devices is drawing condemnation from a major industry group as a step backward for both patients and the industry.

EuroActiv reports that the proposal, fielded by German member of parliament Dagmar Roth-Behrendt, would create a central authority to handle approvals for new devices, similar to the premarket approval process the FDA has in place for Class III medical devices in the U.S. The change would be an enormous move away from Notified Bodies, which are accredited organizations that handle device approvals now.

The push by some to toughen European device regulations comes in the wake of the PIP breast implant scandal in Europe, revolving around a now-defunct company that admitted it sold implants using substandard silicone more prone to leakage. A global safety concern over all-metal hip implants has also fueled consumer groups' call for change.

But with the U.S. approval process a more rigorous and expensive enterprise, medical device companies have increasingly turned to the European Union first. The approval process currently doesn't take as long, and selling products overseas first helps device companies that pursue this path generate revenue and also product data before dealing with the FDA at home. Europe's major industry group--Euromed--isn't pleased with the new regulatory proposal.

According to the story, the trade group cited scientific studies that show a centralized premarket approval system is no safer than the status quo in Europe, and also creates added details that are "unnecessary." Euromed, meanwhile, has begun lobbying efforts to keep the existing regulatory framework in place.

What comes next: Euroactiv reports that Roth-Behrendt will work with peers in the EU's Environment, Public Health and Food Safety Committee to hash out a final version, after which Parliament will vote on a final version.

- read the full story
- here's the draft proposal

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