European drugs agency may start assessing devices

LONDON, June 6 (Reuters) - The European Medicines Agency, already responsible for approving nearly all new medicines in Europe, may also start evaluating medical devices within a few years, its executive director said on Friday. Thomas Lonngren said legislation under discussion in Brussels could well result in the agency being asked to assess high-risk devices.

"Maybe in 2010, 2012 the EMEA will be the medical device agency in the European Union," he told reporters.

Devices in Europe are currently approved under the CE mark scheme, which is administered by eight different bodies across Europe in an unharmonised way.

"The European Commission are not satisifed with the quality of this system and they want to upgrade it," Lonngren added.

The U.S. Food and Drug Administration already evaluates both drugs and devices. Devices include big-selling product lines like orthopaedic implants and coronary stents, and are a growing focus for the global healthcare industry. (Reporting by Ben Hirschler; Editing by Erica Billingham)