EC Public Health · December 19, 2025

MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices

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

MDCG issued guidance on post-market surveillance obligations for medical devices and IVDs under MDR and IVDR.

Medium impact Medical Devices Digital Health & AI EU-wide medical-devicespost-market-surveillanceivd

News announcement 19 December 2025 MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025) MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025) 1 min read

Dates and deadlines

Regulatory Deadline

December 19, 2025

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Published by EC Public Health. HealthSignal links to the original document; the summary above is extracted from the source text.