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Consolidated 10.01.2025

The full consolidated text of Regulation (EU) 2017/746, article by article — searchable, cross-referenced and citable.

Overview

02017R0746 — EN — 10.01.2025 — 005.001

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)

Articles: 114
Chapters: 10
Annexes: 15
Recitals: 101

Where most people start

Article 2DefinitionsThe 74 definitions everything else relies on

Article 10General obligations of manufacturersWhat manufacturers must have in place

Article 110Transitional provisionsTransitional periods for legacy devices

Annex IGeneral safety and performance requirementsGeneral safety and performance requirements (GSPR)

Annex IITechnical documentationContents of the technical documentation

Annex VIIIClassification rulesClassification rules: class A, B, C or D

Article 48Conformity assessment proceduresWhich conformity assessment route applies

Annex XIIIPerformance evaluation, performance studies and post-market performance follow-upPerformance evaluation, studies and PMPF

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Amendments included in this version

Small markers in the text (for example M4) show which act inserted or changed a passage. Hover over a marker to see its source.

BRegulation (EU) 2017/746 — basic actOJ L 117, 5.5.2017EUR-Lex

M1Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022OJ L 19, 28.1.2022, p. 3EUR-Lex

M2Commission Delegated Regulation (EU) 2023/503 of 1 December 2022OJ L 70, 8.3.2023, p. 3EUR-Lex

M3Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023OJ L 80, 20.3.2023, p. 24EUR-Lex

M4Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024OJ L 1860, 9.7.2024, p. 1EUR-Lex

C1Corrigendum, OJ L 117, 3.5.2019, p. 11 (2017/746)

C2Corrigendum, OJ L 334, 27.12.2019, p. 167 (2017/746)

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This tool is provided for convenience only and has no legal effect. Only the texts published in the Official Journal of the European Union are authentic. Source: EUR-Lex, CELEX 02017R0746-20250110, © European Union. Reuse is authorised provided the source is acknowledged.