Medical devices and in vitro diagnostic medical devices

07-06-2016

Medical devices and in vitro diagnostic medical devices cover a wide array of products, from sticking plasters, to heart valves, to state-of-the-art analytical laboratory equipment, with over 500 000 devices on the EU market. 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 tenth trilogue meeting, agreement was reached on both proposals on 25 May 2016. The compromise centres on stricter requirements for notified bodies, stronger pre-market scrutiny and post-marketing surveillance; strengthened rules for high-risk devices and certain other categories of devices; and increased transparency and traceability. This updates a previous edition from December 2015: PE 572.819. A more recent edition of this document is available. Find it by searching by the document title at this address: http://www.europarl.europa.eu/thinktank/en/home.html

Medical devices and in vitro diagnostic medical devices cover a wide array of products, from sticking plasters, to heart valves, to state-of-the-art analytical laboratory equipment, with over 500 000 devices on the EU market. 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 tenth trilogue meeting, agreement was reached on both proposals on 25 May 2016. The compromise centres on stricter requirements for notified bodies, stronger pre-market scrutiny and post-marketing surveillance; strengthened rules for high-risk devices and certain other categories of devices; and increased transparency and traceability. This updates a previous edition from December 2015: PE 572.819. A more recent edition of this document is available. Find it by searching by the document title at this address: http://www.europarl.europa.eu/thinktank/en/home.html