There has been an update to the guidance document MDCG 2021-25 concerning the application of the MDR to legacy devices. To offer some background to this guidance document, the transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) have been revised by Regulation (EU) 2023/607. Notably, the transitional period has been extended to either December 31, 2027, or December 31, 2028, depending on the risk class of the device and subject to specific conditions.
This document offers updated guidance on the application of MDR requirements to ‘legacy devices’ and ‘old’ devices, taking into account the amendments to the MDR’s transitional provisions. The Annex includes a non-exhaustive table showing which MDR requirements apply or do not apply to ‘legacy devices.’
The following updates have been made to MDCG 2021-25:
- Adjustments throughout the document to align with the overall structure of MDCG guidance documents, including the removal of the Preface, Mandate of the taskforce, and process sections.
- Updates to reflect Regulation (EU) 2023/607, which amends Regulations (EU) 2017/745 and (EU) 2017/746 regarding the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
- Significant changes in sections 3.1, 3.2, and 4, including:
- Clarification that Article 19 of the MDR does not apply to legacy devices;
- Clarification on how the transitional provisions apply to systems and procedure packs covered by a declaration made under Article 12(2) of the MDD;
- Clarification of the requirement to implement a quality management system (QMS) in accordance with Article 10(9) of the MDR.
The updated guidance can be accessed using the following link
