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Act · Health

In Vitro Diagnostic Medical Devices Regulation

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. )

IVDR · 32017R0746 · Health · newest amendment in force

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Version in force

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

1 change in this version

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02017R0746-20240709 → 02017R0746-20250110

Version in force

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

4 changes in this version

  • All explained

02017R0746-20230320 → 02017R0746-20240709

Version in force

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

2 changes in this version

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02017R0746-20230311 → 02017R0746-20230320

Version in force

Made by Regulation (EU) 2023/503 32023R0503 on EUR-Lex (external, EUR-Lex)

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)

1 change in this version

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02017R0746-20220128 → 02017R0746-20230311

Version in force

Made by Regulation (EU) 2022/112 32022R0112 on EUR-Lex (external, EUR-Lex)

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)

3 changes in this version

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02017R0746-20170505 → 02017R0746-20220128

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.

13 changes in this version

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32017R0746 → 02017R0746-20170505

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28 dates