Current Edition

Revision of the Medical Devices Directives – A New Regulation

Without doubt, the most significant pieces of legislation to come under the radar for revision in the past number of years are those concerning the regulation of medical devices. Michelle O’Connor of ICON Clinical Research discusses how the new Regulation also builds in contributions to date from the Global Harmonization Task Force (GHTF) and its follow-up initiative the International Medical Devices Regulators Forum – bringing a global perspective to the new legislation.