BioCentury
ARTICLE | Politics & Policy

EU device proposal advances

September 28, 2013 1:00 AM UTC

The European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) voted to advance legislation reforming regulation of high-risk medical devices. High-risk products include devices manufactured from tissues or cells; implantable devices; and devices that contain or deliver drugs. Under the proposed system, independent notified bodies would remain responsible for CE marking devices, but "Special" notified bodies would be certified by EMA as adequately trained and experienced to review high-risk devices.

The legislation also would establish the Assessment Committee for Medical Devices (ACMD), which would have 21 subcommittees comprised of experts from each member state as well as EMA and patients' representatives. The Special notified bodies would be charged with informing ACMD of high-risk applications, and ACMD could make a case-by-case request to review the application. The bill will be considered in the Oct. 21-24 parliamentary session. ...