7 docs tagged with "legislation"

Both MDR 2017/745 and IVDR 2017/746, and all EU implementing and 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).

Annexes I–XVI of Regulation (EU) 2017/746 (IVDR). The IVDR contains 16 Annexes (compared to MDR's 17) that mirror the MDR structure with significant adaptations for the in vitro diagnostic context, including classification rules, conformity assessment procedures, and performance evaluation requirements specific to IVDs.

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.

MDR 2017/745 and IVDR 2017/746 and their amending regulations. This page tracks significant amendments; always verify current status in the Official Journal.

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.

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.