MDR — key articles
The full text of MDR 2017/745 is available in the Official Journal of the EU: OJ L 117, 5.5.2017, p. 1–175. All article references on this site refer to the MDR as amended, including amendments made by Regulation (EU) 2020/561 and Regulation (EU) 2023/607.
IVDR — key articles
The full text of IVDR 2017/746 is available in the Official Journal: OJ L 117, 5.5.2017, p. 176–332. All article references on this site refer to the IVDR as amended, including Regulation (EU) 2022/112 and Regulation (EU) 2024/1860.
MDR Annexes
Annexes I–XVII of Regulation (EU) 2017/745 (MDR). The annexes contain the detailed technical, procedural, and administrative requirements that implement the principles set out in the articles.
IVDR Annexes
Annexes I–XVI of Regulation (EU) 2017/746 (IVDR). The IVDR annexes mirror the MDR structure with adaptations for the in vitro diagnostic context.
Implementing & delegated acts
The legislative framework beneath MDR and IVDR comprises implementing acts (Commission), delegated acts (Commission), Common Specifications (Commission via implementing act), and harmonised European standards (CEN/CENELEC under Commission mandate).
How to read EU legislation
Both MDR 2017/745 and IVDR 2017/746, and all EU implementing and delegated acts.
Recent amendments & corrigenda
MDR 2017/745 and IVDR 2017/746 and their amending regulations. This page tracks significant amendments; always verify current status in the Official Journal.