Background

MDCG 2021-25 is guidance for legacy device manufacturers, on which aspects of the MDR apply to MDD/AIMDD legacy devices. It has been updated to consider Regulation (EU) 2023/607 and to provide additional clarifications. It is available: HERE

Overview

Below are some highlights from the revised guidance.

MDR Article 10(9) Quality Management System

It confirms the requirement “that, since 26 May 2024, manufacturers must comply with Article 10(9) of the MDR”.

However, it notes that some aspects within Article 10(9) are not yet applicable to legacy devices. For example, the following subsections:

• “(b) identification of applicable general safety and performance requirements and exploration of options to address those requirements;
• (e) risk management as set out in in Section 3 of Annex I;
• (f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;”
• (h) verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;”

Note that this does not exempt manufacturers from considering these points as part of their transition plan:

“However, the manufacturer’s QMS should address how compliance with those requirements will be achieved during the transitional period.”

MDR Article 22 Systems and Procedure Packs

The guidance provides updated clarification on Systems and Procedure Packs containing legacy devices.

The transition period for that System/Procedure Packs will end when the transition period for the highest risk device included, is reached.

Declarations of Conformity (DoC)

The guidance calls out that MDR Article 19 is not applicable, i.e., manufacturers should not be updating the legacy device Declarations of Conformity (DoCs) to reference the MDR. As an Authorized Representative, Casus has seen this misinterpretation many times and, therefore, welcomes the MDCG’s explicit explanation to industry on this point.

It notes, however, that manufacturers may add compliance to the MDR Article 120 transition provisions in the DoC, if they so wish. In this case, the DoC should still 1) refer back to the original legislation (MDD/AIMDD), and 2) refer to the original DoC signed prior to May 26, 2021. Further, manufacturers must maintain proper traceability of all DoC revisions.

“For legacy devices, the Declaration of Conformity (DoC) needs to refer to the MDD or AIMDD, as applicable. The manufacturer may additionally declare conformity with Article 120 MDR confirming that the conditions laid down therein are fulfilled.

Where the manufacturer updates its DoC to reflect changes regarding information provided in the declaration (e.g. changes concerning the address, the authorised representative, or the validity date) the manufacturer should add a reference to the DoC which was drawn up for the legacy device before 26 May 2021. In addition, traceability of all versions of the DoC needs to be ensured.”