Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )
- In force
- CELEX number: 32017R0746
- Official Journal: JOL_2017_117_R_0002
- Form: Regulation
- Procedure number: 2012/0267(COD), 2012/0267/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 113.3(f) And 113.3(fa) And 113.3(fb)
- May 25, 2017
- Entry into force - Date pub. +20 See Art 113.1
- November 26, 2017
- Application - Partial application See Art 113.3(b)
- May 26, 2018
- Application - Partial application See Art 113.3(c)
- May 26, 2019
- Application - Partial application See Art 113.3(h)
- November 25, 2020
- Application - Partial application See Art 113.3(d)
- May 26, 2022
- Application - Partial application See Art 113.3(b)
- Application - See Art 113.2
- May 26, 2023
- Application - Partial application See Art 113.3(e)
- May 26, 2024
- Application - Partial application See Art 113.3(i) And 32022R0112
- May 26, 2025
- Application - Partial application See Art 113.3(e)
- May 26, 2027
- Application - Partial application See Art 113.3(e)
- December 31, 2030
- Application - Partial application See Art 113.3(j)
- May 25, 2017
- See Art 108.2
- August 25, 2021
- See Art 108.2
- February 25, 2022
- See Art 106
- May 27, 2027
- Review See Art 111
Modified by
Corrected by:
- May 3, 2019 - 32017R0746R(02)
- December 27, 2019 - 32017R0746R(03)
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
- Commission Delegated Regulation (EU) 2023/503 of 1 December 2022 amending Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (Text with EEA relevance) - detail
- Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices (Text with EEA relevance) - 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
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) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices (Text with EEA relevance)
- Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council (Text with EEA relevance)
- Commission Delegated Regulation (EU) 2023/503 of 1 December 2022 amending Regulation (EU) 2017/746 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) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices
Modifies
Repeal:
- 2010/227/: Commission Decision of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (notified under document C(2010) 2363) (Text with EEA relevance)
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Affected by case
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
- Marketing standard
- Medical device
- Technical barriers
- Medical diagnosis
- Genetics
- Quality standard
- Single market
- Public health
- Safety standard
- Public health
- Internal market - Principles
- Protection of health and safety
- Patient's rights