Les organismes notifiés et les dispositifs médicaux : du constat aux perspectives

On 8 May 2008, the European Commission launched a public consultation on the recast of the Medical Devices Directives. The consultation took the form of a questionnaire which was opened to all interested stakeholders (authorities, industry, notified bodies, healthcare professionals and patients groups). The overall result of the consultation is that the proposal for a recast of the EU legislation on medical devices was not very welcome. However, a certain consensus was noticed concerning some points of the European Commission's recast plan. This was notably the case as regards proposed modifications of the rules governing notified bodies which a majority of the stakeholders considered necessary. The opinions expressed during this public consultation highlighted concerns regarding the current operation of notified bodies. This article examines their current role in the medical devices sector, comments made in the consultation concerning their activities and the European Commission's proposals for modernization of their activities.