Medical Device Regulation

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]. Originally approved medical devices will have a transition time of three years[5][6] (until 26 May 2020) to meet the new MDR requirements.

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 date(new date) 26 May 2021
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

Summary

The date by which the Regulation was to be fully implemented by replacing the previous directives was originally defined as 26 May 2020. Following the international health emergency (COVID-19), the European Commission and the European Parliament decided in April 2020 to postpone the deadline by one year to 26 May 2021.[7]

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References
  1. European Parliament; Council of the European Union (5 April 2017). "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". Eur-Lex. Retrieved 17 February 2020.
  2. "Regulatory framework – Growth – European Commission". Growth.
  3. Duhs, Gustaf (27 March 2018). "A new landscape for medical devices". pharmatimes.com.
  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.
  7. https://www.europarl.europa.eu/doceo/document/TA-9-2020-0053_EN.html
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