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EU lawmakers back strict new approval system for medical devices

By Charlie Dunmore

BRUSSELS (Reuters) - European Union lawmakers backed a strict new approval system for high-tech medical devices on Wednesday, raising industry fears of added delays in getting new products to market that could dull Europe's competitive edge.

Members of the European Parliament's environment committee voted in favor of a new pre-market authorization system of randomized clinical trials for implantable devices, covering everything from hip replacements to artificial heart valves.

Moves to tighten the rules followed a 2011 scandal involving France's now defunct Poly Implant Prothese (PIP), which for up to a decade made substandard breast implants with industrial-grade silicone that were used by hundreds of thousands of women around the world.

Some critics said the scandal was the result of Europe's current authorization system, which is less strict than in the United States where extensive testing is required before new products are approved for sale.

In response, the EU's executive - the European Commission - has proposed increased monitoring of device manufacturers and tougher government oversight of the 80 or so mostly private Notified Bodies that currently decide on product safety.

But Wednesday's committee vote went far beyond the Commission's original proposals, calling for the establishment of a new pre-marketing assessment system for high-risk devices, which would be identified on a case-by-case basis and only authorized with the approval of the European Commission.

Europe's 100 billion euro ($135 billion) medtech industry has said that would add years to the time it takes to bring new devices to market, removing a key advantage that EU companies enjoy over their U.S. rivals.

"The proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe's 25,000 small and medium-sized device makers," EU trade group Eucomed said in a statement.

The body also questions whether the EMA will have the capacity to evaluate the 400 to 600 so-called "Class III", or high-risk, devices that currently reach the market each year in Europe.

Major makers of medical devices include Johnson & Johnson, Medtronic, Boston Scientific, Abbott, Allergan and Smith & Nephew.

Reflecting the deep divisions on the issue, Wednesday's parliamentary vote followed more than 900 amendments by lawmakers to the Commission's original proposal.

If the committee's stance is confirmed by the full parliament in the coming weeks, it will form the basis of the assembly's negotiating position in subsequent talks with EU governments to finalize the rules.

(This correction corrects paragraph 6 to remove reference to European Medicines Agency)

(Editing by Ben Hirschler and Anthony Barker)

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