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

Written by Nicole Scholz (3rd edition)


© Cozyta / Fotolia

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.


Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, and Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
Committee responsible:



Environment, Public Health and Food Safety (ENVI)

Glenis Willmott (S&D, UK)

Peter Liese (EPP, Germany)

COM(2012) 542 and COM(2012) 541 of 26.09.2012

procedure ref.: 2012/0266(COD)

Ordinary legislative procedure

Next steps expected: Vote in plenary scheduled for February

Stage: Second reading

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