Europe – MDCG 2021-25 Rev. 1 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

The transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR)
have been amended by Regulation (EU) 2023/607. In particular, the transitional period
has been extended from 26 May 2024 until 31 December 2027 or 31 December 2028,
depending on the risk class of the device and subject to certain conditions.

This document provides updated guidance as regards the applicability of MDR
requirements to ‘legacy devices’ and ‘old’ devices, taking into consideration the
amendments to the MDR transitional provisions. The annex contains a non-exhaustive
table illustrating MDR requirements applicable or not applicable to ‘legacy devices’…