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. )
Amendments and corrections
December 31, 2030 Application - Partial application See Art 113.3(j)
May 26, 2027 Application - Partial application See Art 113.3(e)
May 26, 2025 Application - Partial application See Art 113.3(e)
January 10, 2025 Modified by 32024R1860 - detail
July 9, 2024 Modified by 32024R1860 - detail
May 26, 2024 Application - Partial application See Art 113.3(i) And 32022R0112
May 26, 2023 Application - Partial application See Art 113.3(e)
March 20, 2023 Modified by 32023R0607 - detail
March 11, 2023 Modified by 32023R0503 - detail
May 26, 2022 Application - Partial application See Art 113.3(b)
Application - See Art 113.2
January 28, 2022 Modified by 32022R0112 - detail
November 25, 2020 Application - Partial application See Art 113.3(d)
December 27, 2019 Corrected by 32017R0746R(03)
May 26, 2019 Application - Partial application See Art 113.3(h)
May 3, 2019 Corrected by 32017R0746R(02)
May 26, 2018 Application - Partial application See Art 113.3(c)
November 26, 2017 Application - Partial application See Art 113.3(b)
May 25, 2017 Entry into force - Date pub. +20 See Art 113.1
January 1, 1001 Application - Partial application See Art 113.3(f) And 113.3(fa) And 113.3(fb)
Consolidated texts
July 9, 2024 Modified by
32017R0746
02017R0746-20230320
32024R1860
02017R0746-20240709
March 20, 2023 Modified by
32017R0746
02017R0746-20230311
32023R0607
02017R0746-20230320
March 11, 2023 Modified by
32017R0746
02017R0746-20220128
32023R0503
02017R0746-20230311
January 28, 2022 Modified by
32017R0746
32022R0112
02017R0746-20220128
May 5, 2017 Modified by
32017R0746
32017R0746R(01)
32017R0746R(02)
32017R0746R(03)
32017R0746R(04)
32017R0746R(05)
02017R0746-20170505
May 5, 2017 Date of publication 32017R0746