Europe risks more delays on device reg reform

Medical device regulatory reform in Europe faced another setback this week. A European Parliament committee has once again tabled a vote on tougher new regulations, putting it off for the second time since July.

The news site European Voice reports that the vote will be postponed from Sept. 18 until Sept. 25 after an initial shift from July. Peter Liese, a German member of parliament, is quoted as saying that the proposal will be ready, as planned, for a full EU parliament vote later this fall, despite the delay in the committee vote. He said he is concerned, however, that member states won't take timely action to sign off on the measure. And so a full Parliament vote may not happen until next year, he explained.

Thus continues a push for regulatory change that has dragged on now for a year.

The now-defunct French breast implant maker Poly Implant Prothèse sparked a scandal, and the subsequent call for tougher EU device regulations, after announcing it had been selling breast implants with substandard silicone for years, leading to thousands of ruptures in the EU and Latin America. Bureaucracy and politics has dampened the initial furor over the PIP case.

Back in July, when the European Parliament's Environment, Public Health and Food Safety Committee delayed its vote on the new regulations, all sides pushed for a delay until Sept. 18 to give time for negotiations over compromise amendments. At issue: a push to move away from certified organizations known as notified bodies to approve devices. Some called for a new U.S.-style centralized PMA approval process. The industry and others opposed this, arguing that it would drastically slow down the process of getting vital new medical devices to market.

European Voice notes that both sides reached a compromise. Changes would give the EU greater control over notified bodies, and companies would face unannounced inspections. But it may take considerable time and effort to push the EU's diverse and conflicting membership into a final vote.

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