MDCG 2025-10: new guidance on post-market surveillance of medical devices and IVDs (December 2025)

Published: 19 Dec 2025

MDCG 2025-10 provides guidance on the post-market surveillance (PMS) system and PMS plan under MDR and IVDR, covering main PMS activities, interactions with other QMS elements, and an annex overview of PMS obligations. It excludes detailed PSUR preparation, which is covered by MDCG 2022-21, and the health institution exemption under Article 5(5). Manufacturers should review their PMS systems and plans against this guidance.

Original title: MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025)

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