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Act · Health

Medical Devices Regulation

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. )

32017R0745 · Health · newest amendment in force

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Version in force

Made by Regulation (EU) 2025/2457 32025R2457 on EUR-Lex

Regulation (EU) 2025/2457 of the European Parliament and of the Council of 26 November 2025 amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 as regards the reattribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals (Text with EEA relevance)

1 change in this version

  • All explained

02017R0745-20250110 → 02017R0745-20260101

Version in force

Made by Regulation (EU) 2024/1860 32024R1860 on EUR-Lex · Regulation (EU) 2024/568 32024R0568 on EUR-Lex

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)

2 changes in this version

  • All explained

02017R0745-20240709 → 02017R0745-20250110

Version in force

Made by Regulation (EU) 2024/1860 32024R1860 on EUR-Lex

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)

5 changes in this version

  • All explained

02017R0745-20230320 → 02017R0745-20240709

Version in force

Made by Regulation (EU) 2023/607 32023R0607 on EUR-Lex

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)

3 changes in this version

  • All explained

02017R0745-20230311 → 02017R0745-20230320

Version in force

Made by Regulation (EU) 2023/502 32023R0502 on EUR-Lex

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)

1 change in this version

  • 1 without an explanation

02017R0745-20200424 → 02017R0745-20230311

Version in force

Made by Regulation (EU) 2020/561 32020R0561 on EUR-Lex

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)

9 changes in this version

  • 3 substantive
  • 6 dates only
  • All explained

02017R0745-20170505 → 02017R0745-20200424

Version detected

no amending act named In force date not stated.

No amending act is named for this version: the EU's own amendment metadata annotated nothing in this window and there were no amending-act instructions to read, so only the text comparison observed it. That is a fact about the corpus's records for the window, not a doubt about the text shown below.

15 changes in this version

  • All explained

32017R0745 → 02017R0745-20170505

Dates the amended text names

Every date an amendment added to or removed from a provision's text, as the parser read it, with the provision and the version. This is a list of dates the text contains. Whether a provision applies from one of them is stated for each change under "applies from", and nowhere else.

40 dates