Updated MDCG 2021-25 on MDR legacy requirements

MDCG just updated its guidance document on the application of MDR requirements to legacy devices and to devices placed on the market prior to 26 May 2021 in accordance with the previous Directives. This is the first update since its initial issue in October 2021. The changes include some adjustments in the entire document to align with the general structure of MDCG guidance documents and to take into account Regulation (EU) 2023/607 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. Essentially, the key updates are:

• Clarification that Article 19 MDR does not apply to legacy devices;
• Clarification of transitional provisions’ application to systems and procedure packs covered by a declaration drawn up pursuant to Article 12(2) MDD;
• Clarification regarding the requirement to put in place a QMS in accordance with Article 10(9) MDR.

Key points of MDCG 2021-25

MDCG 2021-25 provides guidance in regards to:

1. The requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices apply to “legacy devices”.
2. The transitional period also applies to systems and procedure packs:
   1. When the involvement of a notified body is required according to to the MDR,
   2. Which consist only of ‘legacy devices’ and
   3. For which a declaration has been drawn up in accordance with Article 12(2) of the MDD prior to 26 May 2021.
3. Manufacturers must put in place a quality management system (QMS) in accordance with Article 10(9) of the MDR no later than 26 May 2024 in order to be allowed to place their ‘legacy devices’ on the market after that date.
4. The verification of UDI assignments only applies where UDI assignment is actually required for the relevant devices.
5. Serious incidents involving an ‘old’ device and field safety corrective actions (FSCA) in respect of ‘old’ devices must be reported in accordance with Article 87 MDR.

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