MEPs confirm commitment to tougher conformity assessment of medical devices

摘要

The European Parliament has confirmed that it will continue to push for a revised conformity assessment procedure and other enhancements in the impending reform of the European Medical Devices Directive 93/42/EEC. The position was agreed in a vote of the parliament’s Committee for Environment, Public Health and Food Safety in September and ratified via plenary vote by the whole body in late October. Manufacturers of medical devices have previously expressed reservations about the proposed new systems; claiming it would stifle innovation and prolong the time it took life-saving devices to reach patients.