you're reading...
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

Leave a Reply

Download the EPRS App

EPRS App on Google Play
EPRS App on App Store
What Europe Does For You
EU Legislation in Progress
Topical Digests
EPRS Podcasts

Follow Blog via Email

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 3,544 other subscribers

RSS Link to Members’ Research Service

Disclaimer and Copyright statement

The content of all documents (and articles) contained in this blog is the sole responsibility of the author and any opinions expressed therein do not necessarily represent the official position of the European Parliament. It is addressed to the Members and staff of the EP for their parliamentary work. Reproduction and translation for non-commercial purposes are authorised, provided the source is acknowledged and the European Parliament is given prior notice and sent a copy.

For a comprehensive description of our cookie and data protection policies, please visit Terms and Conditions page.

Copyright © European Union, 2014-2019. All rights reserved.

%d bloggers like this: