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. )
- In force
- CELEX number: 32017R0745
- Official Journal: JOL_2017_117_R_0001
- Form: Regulation
- Procedure number: 2012/0266(COD), 2012/0266/COD
- Languages:
- bg
- cs
- da
- de
- el
- en
- et
- fi
- fr
- ga
- hr
- hu
- it
- lv
- lt
- mt
- nl
- pl
- pt
- ro
- sk
- sl
- es
- sv
Dates
Date of document: - April 5, 2017
- May 5, 2017
- January 1, 1001
- Application - Partial application See Art 123.3(d) And 123.3(e) And 123.3(ea)
- May 25, 2017
- Entry into force - Date pub. +20 See Art 123.1
- November 26, 2017
- Application - Partial application See Art 123.3(a) And 123.3(b)
- May 26, 2018
- Application - Partial application See Art 123.3(c)
- May 26, 2019
- Application - Partial application See Art 123.3(i)
- April 24, 2020
- Application - Partial application See Art 123.3(j)
- May 26, 2021
- Application - See Art 123.2
- Application - Partial application See Art 123.3(a) And 123.3(f)
- May 26, 2023
- Application - Partial application See Art 123.3(f) And 123.3(g)
- May 26, 2025
- Application - Partial application See Art 123.3(f) And 123.3(g)
- May 26, 2027
- Application - Partial application See Art 123.3(g)
- May 25, 2017
- See Art 115.2
- April 24, 2020
- See Art 59
- February 25, 2021
- See Art 113
- March 25, 2021
- See Art 34.1
- May 25, 2021
- See Art 59
- May 26, 2021
- See Art 1.2 And 17 And 120
- August 25, 2021
- See Art 115.2
- May 27, 2027
- See Art 121
Modified by
Corrected by:
- May 3, 2019 - 32017R0745R(01)
- December 27, 2019 - 32017R0745R(02)
Modified by:
- Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (Text with EEA relevance) - detail
- Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95 - detail
- Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices (Text with EEA relevance) - detail
- Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses - detail
- Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (Text with EEA relevance) - detail
- Commission Delegated Regulation (EU) 2023/502 of 1 December 2022 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (Text with EEA relevance) - detail
All documents based on this document:
- Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Text with EEA relevance. )
- Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)
- Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices
- Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2023/502 of 1 December 2022 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses
Modifies
Modifies:
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)
- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
- Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
Repeal:
Implicit repeal:
- Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty
- Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
- Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance)
- Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance)
Affected by case
- Case C-10/24, Cattani: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 9 January 2024 — Dürr Dental SE v Cattani Deutschland Helmes GmbH & Co. KG
- article 14 paragraph 1
- article 14 paragraph 2 unnumbered paragraph 1 point (a)
- article 14 paragraph 2 unnumbered paragraph 3
Legal basis
- Consolidated version of the Treaty on the Functioning of the European Union PART THREE - UNION POLICIES AND INTERNAL ACTIONS TITLE XIV - PUBLIC HEALTH Article 168 (ex Article 152 TEC)
- Consolidated version of the Treaty on the Functioning of the European Union PART THREE - UNION POLICIES AND INTERNAL ACTIONS TITLE VII - COMMON RULES ON COMPETITION, TAXATION AND APPROXIMATION OF LAWS CHAPTER 3 - APPROXIMATION OF LAWS Article 114 (ex Article 95 TEC)
EuroVoc Vocabulary
- Medical devices
- Market supervision
- Market approval
- Quality standard
- Safety standard
- Public health
- Internal market - Principles
- Marketing standard
- Medical device
- Testing
- Harmonisation of standards
- EC conformity marking
- Protection of health and safety
- Health legislation