Update to MDCG 2021-25: Key Clarifications on MDR Transition

The MDCG 2021-25 (Rev1.0) has been updated, reflecting the latest developments in the MDCG MDR Transition. The guidance now takes into account Regulation (EU) 2023/607, which amends Regulations (EU) 2017/745 and (EU) 2017/746 concerning the transitional provisions for certain medical devices and IVDs.

Substantial changes were included in particular in sections 3.1, 3.2 and 4.

MDCG 2021-25 clarifications for the MDR transition:

• • Clarification was added to ensure it is understood that Article 19 MDR (EU Declaration of Conformity) does not apply to legacy devices.
  • Clarification of the application of the transitional provisions to systems and procedure packs covered by a declaration drawn up pursuant to Article 12(2) MDD; the transitional period for a ‘legacy system or procedure pack’ ends when the transitional period ends for the legacy device of the highest risk class included in the SPP.
  • Clarification regarding the requirement to put in place a QMS in accordance with Article 10(9) MDR.

Manufacturers must already have put a QMS in place by 26th May 2024 compliant with MDR, complying with Article 10(9) of the MDR. For some aspects of the QMS it is not necessary to be MDR compliant, for example, it is not required that manufacturers have identified all relevant general safety and performance requirements, have a risk management system as per Annex 1 MDR, section 3. A clinical evaluation for a legacy device under Article 61 and Annex XIV of the MDR is also not expected. The QMS should address how compliance with those requirements will be achieved during the transitional period.

Application of MDR requirements to devices placed on the market prior to 26 May 2021: Legacy devices involved in serious incidents and FSCA’s must be reported in accordance with Article 87 MDR.

Click here to read the full guidance update.

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