At the end of December, the MDCG published new guidance on post-market surveillance.
MDCG 2025-10 sets out the requirements for post-market surveillance (PMS) systems under the MDR and IVDR in more detail and describes how manufacturers must systematically monitor the safety, performance and quality of their products across the entire lifecycle.
You can download the document here: MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices December 2025