[CE, MDR] MDCG 2021-25 rev.1 - Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 - October 2024

1. Introduction

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’.

 

 

MDCG 2021-25 rev.1 - Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 - October 2024 - European Commission

MDCG 2021-25 rev.1 - Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 202

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