EU medical device regulation

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Regulation
European Union regulation
TitleRegulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )
Made byCouncil
Made underTFEU/art 294 par 6
Journal referenceL117, 5 May 2017 pp. 1–175
History
Date made5 April 2017
Came into force25 May 2017
Implementation date26 May 2020
Other legislation
ReplacesDirective 90/385/EEC, Directive 93/42/EEC
AmendsDirective 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
Current legislation

The European Union Medical Device Regulation (Council Regulation 2017/745 of 5 April 2017[1] concerning medical devices, OJ No L 117/1 of 2017-05-05) repeals the existing directives on medical devices: Medical Devices Directive [93/42/EEC] and Active Implantable Medical Device Directive [90/385/EEC]. The regulation was published on 5 May 2017 and came into force on 25 May 2017[2][3][4]. Currently approved medical devices will have a transition time of three years[5][6] (until 26 May 2020) to meet the new MDR requirements.

References[edit]

  1. ^ Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance) (html)
  2. ^ "Regulatory framework – Growth – European Commission". Growth.
  3. ^ Duhs, Gustaf (27 March 2018). "A new landscape for medical devices". pharmatimes.com. Italic or bold markup not allowed in: |website= (help)
  4. ^ "EU Parliament Adopts New Medical Device, IVD Regulations, 5 April 2017 (html)".
  5. ^ "EU Medical Device Regulation". tuv-sud.com.
  6. ^ "New Medical Devices Regulation and IVD Regulation text published – BSI Group". bsigroup.com. Italic or bold markup not allowed in: |website= (help)