Regulation (EU) 2023/607 amended the transition timeline for medical devices. MDCG 2021-25 (Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and

to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC) provides guidance on the requirements for medical devices throughout the transition periods.

Regulation (EU) 2024/1860 amended the transition timeline for IVDs. MDCG 2022-8 (Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 27 May 2022 in accordance with Directive 98/79/EC) provides guidance on the requirements for IVD devices throughout the transition periods.