Medical devices and in vitro diagnostic medical devices [EU Legislation in Progress]

Written by Nicole Scholz (4th edition)

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.

Following Parliament’s first readings in April 2014, the Council agreed its positions in October 2015. At the conclusion of the trilogues, agreement was reached 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. Both draft texts were adopted by the Council on 7 March 2017, and Parliament’s second-reading vote on 5 April completed the adoption procedure. The regulation on medical devices will become fully applicable in May 2020, and that on in vitro diagnostic medical devices in May 2022.

Versions

• May 2017: Medical devices and in vitro diagnostic medical devices (4th edition)
• January 2017: Medical devices and in vitro diagnostic medical devices (3rd edition)
• June 2016: Medical devices and in vitro diagnostic medical devices (2nd edition)
• December 2015: Medical devices and in vitro diagnostic medical devices (1st edition)