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Economic and Social Policies, PUBLICATIONS

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

Written by Nicole Scholz (4th 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.

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.



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

Procedure completed:


Regulation (EU) 2017/745

Regulation (EU) 2017/746

OJ L 117, 5.5.2017

Stage: adoption

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