Medical devices and in vitro diagnostic medical devices

29-03-2017

The current EU approval system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) is based on conformity assessment by 'notified bodies'. A number of scandals stressed the need to tighten the regulatory framework for such devices. The European Commission's proposals for regulations on MDs and IVDs, being discussed in parallel, are extensive and will repeal all existing rules. Votes in Parliament at second reading are expected during the April I plenary.

The current EU approval system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) is based on conformity assessment by 'notified bodies'. A number of scandals stressed the need to tighten the regulatory framework for such devices. The European Commission's proposals for regulations on MDs and IVDs, being discussed in parallel, are extensive and will repeal all existing rules. Votes in Parliament at second reading are expected during the April I plenary.