Medical devices and in vitro diagnostic medical devices

Briefing 16-01-2017

Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012, to update the framework. Following Parliament's first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogue meetings, agreement was reached on both proposals on 25 May 2016. This was endorsed by the Council's Permanent Representatives Committee on 15 June and confirmed by Parliament's ENVI Committee on the same day. Political agreement in the Council was reached in September. Both drafts are now undergoing legal-linguistic revision. The formal first reading of the Council is expected early this year, followed by final approval, at second reading, by Parliament. This updates a previous edition, from June 2016: PE 583.812.