Regulation (EU) 2017/745

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

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC, which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021.

The regulation was published on 5 April 2017 and came into force on 25 May 2017.[1][2][3] Originally approved medical devices will have a transition time of three years[4][5] (until 26 May 2021) to meet new requirements.

Changes

Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC) and of the economic operator concept, the requirement of UDI marking for devices, Eudamed registration, and increased post-market surveillance activities.

Scope and classification

The scope of the MDR has been expanded to cover a range of products without an intended medical purpose. This category includes some contact lenses, tattoo removal lasers, equipment for liposuction, and others. Annex XVI of the MDR lists all the respective categories. Additionally, the classification rules of Annex VIII of the MDR have been expanded compared to the MDD to now 22 rules. Reusable surgical instruments are now been included in their own category, often called "I R". As per § 120(3) of the regulation, aspects relating to their re-usability are under the scope of Notified Body review starting 26th of May, 2024. Other classification changes relate to software (rule 11) and nanomaterials (rule 19).

Economic operator roles

The MDR in §2 (35) now defines several different roles for economic operators in relation to medical devices:

  • Manufacturer
  • Authorised Representative
  • Importer
  • Distributor

Implementation date

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.[6]

Additional provisions for the transition from MDD to MDR are found in Article 120 of the regulation.

See also

  • Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

References

  1. ↑ "Regulatory framework – Growth – European Commission". Growth. 12 May 2020.
  2. ↑ Duhs, Gustaf (27 March 2018). "A new landscape for medical devices". pharmatimes.com.
  3. ↑ "EU Parliament Adopts New Medical Device, IVD Regulations, 5 April 2017 (html)".
  4. ↑ "EU Medical Device Regulation". tuv-sud.com.
  5. ↑ "New Medical Devices Regulation and IVD Regulation text published – BSI Group". bsigroup.com.
  6. ↑ "Texts adopted - Medical devices ***I - Friday, 17 April 2020".
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