First Revision of MDCG 2021-25 Released
First Revision of MDCG 2021-25 Released
Regulatory Affairs Medical Devices
Tuesday, 29 October 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On October 16, 2024, the Medical Device Coordination Group (MDCG) released Revision 1 of the guidance on the “Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021” (MDCG 2021-25). This update includes adjustments to align the entire document with the general structure of MDCG guidance documents and to take into account Regulation (EU) 2023/607.
First Revision of MDCG 2021-25 Released | QbD Group Regulatory Update
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This guidance outlines how MDR requirements relate to “legacy devices” and “old devices.” Legacy devices are defined as those that, in line with Article 120(3) of the MDR, are placed on the market or put into service after the MDR’s date of application (DoA) and until either 31 December 2027 or 31 December 2028 if the conditions set in Article 120(3c) of the MDR are fulfilled. In contrast, old devices refer to those placed on the market before 26 May 2021, in compliance with the AIMDD or the MDD, or under the relevant regulations before the Directives were enacted.
Through this guidance, the MDCG clarifies that the MDR’s requirements for post-market surveillance, market surveillance, and vigilance are applicable to legacy devices. The document also addresses Article 86 of the MDR concerning the periodic safety update report (PSUR), stating that manufacturers of legacy devices must prepare and maintain PSURs according to this specific MDR Article.
Other MDR requirements related to post-market surveillance, market surveillance, vigilance, and the registration of economic operators and devices should also apply to legacy devices. However, MDR provisions not related to these areas generally do not apply to economic operators concerning legacy devices. It is important to note that the requirements for market surveillance activities under the MDR do extend to old devices.
In this first revision, significant modifications are especially noted in sections 3.1, 3.2, and 4, which include:
- Clarification that Article 19 of the MDR does not apply to legacy devices.
- Explanation of how the transitional provisions apply to systems and procedure packs covered by a declaration established under Article 12(2) of the Medical Device Directive (MDD).
- Emphasis on the necessity of implementing a Quality Management System (QMS) in accordance with Article 10(9) of the MDR.
What does it mean to you?
MDCG 2021-25 provides relevant insights into the applicability of the MDR to “legacy” devices and “old” devices.
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