European Union medical device regulations
Official sources linkedEU MDR rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
12 documents6 categories100% linked to official sourcesauthority EU MDR11 readable HTML
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Regulation (EU) 2024/1860 | Amendment to MDR and IVDR transitional provisions Amending regulation, date of the act 13 June 2024, OJ publication 9 July 2024. Article 3: enters into force on the day of OJ publication; Article 1(1) and Article 2(1) apply from 10 January 2025. | Registration | July 9, 2024 | Official |
| Regulation (EU) 2017/746 | In Vitro Diagnostic Medical Devices Regulation Authentic Official Journal expression of the IVDR. Ingested from EUR-Lex CONVEX HTML for CELEX 32017R0746. Date of the act is 5 April 2017; OJ L 117/176 publication is 5 May 2017. | General | May 26, 2022 | Official |
| Regulation (EU) 2022/112 | Amendment to IVDR transitional periods Amending regulation, date of the act 25 January 2022, OJ L 19/3 publication 28 January 2022. Article 2: enters into force on the day of OJ publication. | General | January 28, 2022 | Official |
| Regulation (EU) 2017/745 | Medical Device Regulation Authentic Official Journal expression of the EU Medical Device Regulation. Ingested from EUR-Lex CONVEX HTML for CELEX 32017R0745. Date of the act is 5 April 2017; OJ L 117 publication is 5 May 2017. Date of application 26 May 2021 is from Article 123. | Registration | May 26, 2021 | Official |
| Regulation (EU) 2017/745 (consolidated) | Medical Device Regulation — consolidated 19 July 2026 EUR-Lex consolidated expression 02017R0745-20260719 (007.001), current through 19 July 2026 — the newest official consolidation, confirmed by enumerating every 02017R0745 expression in the Publications Office Cellar (SPARQL). Bytes fetched from the Cellar master repository (publications.europa.eu) because eur-lex.europa.eu redirects script egress to a Today-OJ interstitial. Official disclaimer: the consolidation is a documentation tool and has no legal effect; authentic recitals remain in the Official Journal expression. Kept distinct from CELEX 32017R0745. | Registration | — | Official |
| Regulation (EU) 2017/746 (consolidated) | In Vitro Diagnostic Regulation — consolidated 10 January 2025 EUR-Lex consolidated expression 02017R0746-20250110 — still the newest official IVDR consolidation: every 02017R0746 expression in the Publications Office Cellar was enumerated via SPARQL on 29 August 2026 and none is dated later than 10 January 2025. Kept distinct from the authentic OJ text. Recitals are omitted from this consolidation, as EUR-Lex states. | General | — | Official |
| EUDAMED | European Database on Medical Devices EUDAMED is an official database portal, not a single legal instrument. Not ingested as corpus source text. | UDI | — | Official |
| MDCG 2025-9 | Guidance on Breakthrough Devices (BtX) MDCG 2025-9 (December 2025) Breakthrough Devices guidance. Ingested as numbered sections sec-1 through sec-14 from the official PDF. Not part of the EUR-Lex binding-text family. | Registration | — | Official |
| MDCG 2025-6 | FAQ on MDR/IVDR and Artificial Intelligence Act Exact MDCG FAQ PDF on MDR/IVDR and the AI Act. Ingested with FAQ-question anchors q-1–q-36 plus the five official theme sections. | Software/SaMD | — | Official |
| MDCG 2019-16 Rev. 1 | Guidance on Cybersecurity for Medical Devices MDCG 2019-16 Rev. 1 cybersecurity guidance. Cover states December 2019 with July 2020 rev.1. Ingested as numbered sections sec-1 through sec-10 (Annexes I–IV as sec-7–sec-10) from the official PDF. | Software/SaMD | — | Official |
| MDCG 2021-24 Rev. 1 | Guidance on Classification of Medical Devices MDCG 2021-24 Rev. 1 classification guidance. The official file still uses the 2021-10 path; the PDF cover is Rev.1 April 2026. Ingested as numbered sections sec-1 through sec-4-2, matching the official table of contents. Rule-level examples live inside sec-4-2 rather than as separate numbered chapters. | Classification | — | Official |
| MDCG 2020-1 | Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) Exact MDCG PDF for clinical/performance evaluation of medical-device software. Ingested with the complete official outline, including 4.4.1/4.4.2 clauses, Annex I, and Annex II examples a)–f). | Clinical Trials | — | Official |
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Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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Tracked from official EU MDR publications · row IDs are stable — cite as regulations:eu:mdr-2017-745