Written by Nicole Scholz (1st edition)
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 reading in April 2014, the Council agreed its position in October 2015. Interinstitutional negotiations are under way, with trilogue meetings having taken place on 13 and 28 October, on 11 and 28 November, and on 3 December.
Stakeholders generally welcome the progress made, with industry asking for the elimination of burdensome requirements, and patient and consumer associations stressing the need for information.
December 2015: Medical devices and in vitro diagnostic medical devices (1st edition)