Regulation (EU) 2017/745 on medical devices

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Series Details L 117, Pages 1-175
Publication Date 05/05/2017
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Summary:

Regulation (EU) 2017/745 - formally adopted by the co-legislators on 5 April 2017 - concerning the safety and performance of medical devices in the European Union. It is also known as the Medical Devices Regulation (MDR). This is a text with EEA relevance.

Further information:

This Regulation updates the rules on placing on the market, making available and putting into service medical devices for human used and their accessories. It also contains rules on how clinical investigations concerning such devices and accessories are carried out in the European Union (EU). It introduces more stringent procedures for conformity assessment and post-market surveillance. It amends Directive 2001/82/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. It also repeals Council Directive 90/385/EEC and Council Directive 93/42/EEC.

The draft law was tabled by the European Commission on 26 September 2012 as part of a legislative package on the safety of medical devices. It was put forward in the aftermath of criticism relating the existing regulatory framework, particularly following scandals relating to metal-on-metal artificial hips and faulty silicone breast implants. Substantial divergence was noted in the interpretation and application of the rules, thus undermining the aims of the framework. Certain regulatory gaps and uncertainties were also detected with regard to certain products.

The plenary of the European Parliament adopted its negotiating position on 2 April 2014, followed by the Council of the European Union on 19 June 2015 (technical adjustments finalised in September 2015). An informal agreement between the co-legislators on the text for this draft law was reached on 25 May 2016. This endorsed by the Council on 7 March 2017 and the Parliament on 5 April. The Act was signed by the co-legislators on 5 April 2017 and published in the Official Journal on 5 May 2017. Its application started on 26 May 2021.

Source Link http://data.europa.eu/eli/reg/2017/745/oj
Related Links
Commentary and Analysis
EurActiv: Special Reports: Medical devices regulation https://www.euractiv.com/section/all/special_report/medical-devices-regulation/
EPRS: In-Depth Analysis, January 2013: Medical Devices and In-Vitro Medical Devices - Initial Appraisal of the European Commission's Impact Assessment https://www.europarl.europa.eu/thinktank/en/document.html?reference=IPOL-JOIN_NT(2013)496737
EPRS: Briefing, December 2015: Medical devices and in vitro diagnostic medical devices https://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_BRI(2015)572819
EPRS: Briefing, January 2017: Medical devices and in vitro diagnostic medical devices https://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_BRI(2017)595881
EPRS: At a Glance, March 2017: Medical devices and in vitro diagnostic medical devices https://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_ATA(2017)599366
EPRS: Briefing, May 2017: Medical devices and in vitro diagnostic medical devices https://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_BRI(2017)603916
Reuters, 06/06/2019: Will Europe's clampdown on faulty medical devices hurt patients? https://www.reuters.com/article/us-eu-medical-devices-insight-idUSKCN1T70HN

News
EurActiv, 26/09/2012: EU launches debate over authorisation of medical devices https://www.euractiv.com/section/health-consumers/news/eu-launches-debate-over-authorisation-of-medical-devices/
EurActiv, 09/07/2013: Danes want chemicals out of medical devices https://www.euractiv.com/section/health-consumers/news/danes-want-chemicals-out-of-medical-devices/
EurActiv, 26/09/2013: MEPs vote for stricter approval system for medical devices https://www.euractiv.com/section/health-consumers/news/meps-vote-for-stricter-approval-system-for-medical-devices/
Spiegel Online International, 17/10/2013: Medical Device Makers Battle Tougher EU Laws https://www.spiegel.de/international/europe/medical-device-makers-lobby-against-tighter-eu-licensing-rules-a-928191.html
EurActiv, 23/10/2013: Parliament wants tougher medical devices control without extra burdens for SMEs https://www.euractiv.com/section/health-consumers/news/parliament-wants-tougher-medical-devices-control-without-extra-burdens-for-smes/
EUObserver, 08/12/2014: Medical devices face uncertain diagnosis in EU https://euobserver.com/social/126807
EurActiv, 13/06/2016: New medical devices rules should avoid ‘unnecessary’ red tape, industry says https://www.euractiv.com/section/health-consumers/news/new-medical-devices-rules-should-avoid-unnecessary-red-tape-industry-says/
EUObserver, 05/04/2017: Breast implant scandal triggers more EU oversight https://euobserver.com/health/137509
EurActiv, 06/04/2017: Parliament wants medical devices traced, scrutinised https://www.euractiv.com/section/health-consumers/news/parliament-medical-devices-should-be-traced-and-under-post-market-scrutiny/

Official
EUR-LEX: COM(2012)542: Proposal for a Regulation on medical devices http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2012:542:FIN
EUR-LEX: SWD(2012)273: Staff Working Document accompanying the Proposal - Impact assessment http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2012:273:FIN
EUR-LEX: SWD(2012)274: Staff Working Document accompanying the Proposal - Summary of the impact assessment http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2012:274:FIN
European Parliament: Legislative Observatory: Procedure File for Proposal on Medical devices (2012/0266(COD)) https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2012/0266(COD)
EU EMA: Human Regulatory: Medical Devices https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
European Commission: DG Health: Medical Devices - Sector https://ec.europa.eu/health/md_sector/overview_en
General Secretariat of the Council: Policies: Modernising EU rules for medical devices https://www.consilium.europa.eu/en/policies/new-rules-medical-in-vitro-diagnostic-devices/
European Commission: Press Release, 26/09/2012: Safer, more effective and innovative medical devices https://ec.europa.eu/commission/presscorner/detail/en/IP_12_1011
European Commission: Memo, 26/09/2012: Questions and answers: Commission tables proposals for a new EU Regulatory Framework for Medical Devices and In Vitro Diagnostic Medical Devices https://ec.europa.eu/commission/presscorner/detail/en/MEMO_12_710
European Parliament: Press Release, 25/09/2013: Health MEPs call for stricter controls on medical devices https://www.europarl.europa.eu/news/en/press-room/20130923IPR20607/
European Commission: Speech, 11/10/2013: Medical Devices: new legislation to tackle new challenges https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_13_811
EP Library: At a Glance, October 2013: Safe and innovative medical devices https://www.europarl.europa.eu/thinktank/en/document.html?reference=LDM_BRI(2013)130659
European Parliament: Press Release, 22/10/2013: Medical implants: better controls and traceability to ensure patients’ safety https://www.europarl.europa.eu/news/en/press-room/20131021IPR22721/
European Commission: Memo, 22/10/2013: Commissioner Mimica welcomes the EP Plenary Vote on medical devices and In vitro diagnostics https://ec.europa.eu/commission/presscorner/detail/en/MEMO_13_921
European Parliament: Press Release, 02/04/2014: Medical devices: better controls and traceability to ensure patients’ safety https://www.europarl.europa.eu/news/en/press-room/20140331IPR41182/
European Commission: Commissioner Mimica welcomes the EP Plenary vote on medical devices and in vitro diagnostics (2 April 2014) https://ec.europa.eu/commission/presscorner/detail/en/STATEMENT_14_93
Council of the European Union: Press Release, 19/06/2015: Medical devices: Council getting ready for talks with EP https://www.consilium.europa.eu/en/press/press-releases/2015/06/19/medical-devices-council-ready-talk-with-ep/
Council of the European Union: Press Release, 23/09/2015: Medical devices: Council mandates presidency to start talks with EP https://www.consilium.europa.eu/en/press/press-releases/2015/09/23/medical-devices/
Council of the European Union: Press Release, 25/05/2016: Medical devices: deal reached on new EU rules https://www.consilium.europa.eu/en/press/press-releases/2016/05/25/medical-devices/
European Parliament: Press Release, 26/05/2016: Safer medical devices: MEPs strike deal with Council https://www.europarl.europa.eu/news/en/press-room/20160526IPR29427/
EPRS: Briefing, June 2016: Medical devices and in vitro diagnostic medical devices https://www.europarl.europa.eu/thinktank/en/document.html?reference=EPRS_BRI(2016)583812
European Parliament: Press Release, 15/06/2016: Medical devices: Health Committee MEPs approve stricter EU safety requirements https://www.europarl.europa.eu/news/en/press-room/20160613IPR32057/
Council of the European Union: Press Release, 15/06/2016: Medical devices: Council confirms deal with EP https://www.consilium.europa.eu/en/press/press-releases/2016/06/15/medical-devices/
Council of the European Union: Press Release, 07/03/2017: Safer medical devices: Council adopts new EU rules https://www.consilium.europa.eu/en/press/press-releases/2017/03/07/safer-medical-devices/
European Parliament: Press Release, 05/04/2017: Medical devices: more safety, more traceability https://www.europarl.europa.eu/news/en/press-room/20170329IPR69055/
European Commission: Memo, 05/04/2017: New EU rules to ensure safety of medical devices https://ec.europa.eu/commission/presscorner/detail/en/MEMO_17_848
European Commission: Press Release, 05/04/2017: New EU rules on medical devices to enhance patient safety and modernise public health https://ec.europa.eu/commission/presscorner/detail/en/IP_17_847
UK Government: Guidance: Medical devices: EU regulations for MDR and IVDR (Northern Ireland) https://www.gov.uk/guidance/medical-devices-eu-regulations-for-mdr-and-ivdr
European Commission: Questions & Answers: Application of Regulation on Medical Devices – EU rules to ensure safety of medical devices (26 May 2021) https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_2619
European Commission: Press Release, 26/05/2021: Public health: Stronger rules on medical devices https://ec.europa.eu/commission/presscorner/detail/en/ip_21_2617

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