European Union medical device regulations

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.

Amending regulation, date of the act 15 March 2023, OJ L 80 publication 20 March 2023. Article 1 deletes the sell-off date from Article 120(3) and (4) MDR and inserts new Article 120(3a) to (3f), which tie the extended transitional periods for class III implantable and class IIb active devices to a notified-body agreement signed before 26 September 2024; Article 2 makes the corresponding IVDR change in Article 110(4); Article 3 provides that the regulation entered into force on the day of OJ publication. Ingested from the EUR-Lex CONVEX HTML expression for CELEX 32023R0607.

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.

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.

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.

EUDAMED is an official database portal, not a single legal instrument. Not ingested as corpus source text.

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.

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.

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).

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.

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.

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.

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.