MDCG publishes new guideline on post-market surveillance
26 December 2025
The Medical Device Coordination Group (MDCG) has recently released MDCG 2025-10, a comprehensive guidance document addressing post-market surveillance (PMS) requirements for medical devices and in vitro diagnostic medical devices. This guidance aims to clarify the interpretation of PMS requirements outlined under Article 83 of the Medical Devices Regulation (MDR) and Article 78 of the In Vitro Diagnostic Devices Regulation (IVDR).
The released guidance highlights the necessity for manufacturers, including those producing custom-made devices, to develop and maintain a PMS system. The PMS plan, which is dynamic and continually updated throughout the device’s lifecycle, specifies the methods for data collection and analysis, threshold values that trigger reassessment, and specific details for manufacturers of custom-made devices. Moreover, the guidance outlines the primary activities within a PMS system, such as identifying suitable information sources, gathering and analyzing data, drawing conclusions, and implementing necessary actions. Another integral aspect emphasized in the guidance is the interaction of the PMS system with broader Quality Management System (QMS) processes. It is essential that insights derived from PMS are utilized within QMS activities, enabling manufacturers to reassess risks, update clinical and performance evaluations, and refine device design and labelling.
The MDCG underlines a proactive approach to surveillance, ensuring continuous monitoring and improvement of devices. Manufacturers are required to seek data from various sources, including scientific literature, user feedback, registries, and information on similar products. Furthermore, the PMS plan must be dynamic, evolving with new insights throughout the device’s lifespan. This data and insights gained from PMS activities are critical for enhancing the technical documentation, such as risk assessment files and clinical evaluation reports.
Manufacturers must understand that PMS is an ongoing obligation that persists through the entire lifetime of the device. Continuous collection of post-market information is vital to monitor the safety, quality, and performance of medical devices and implement preventive and corrective actions as required. As experts in regulatory compliance for medical devices, we can assist you with any questions you might have regarding PMS, MDR, IVDR, and related guidance documents. Our consultancy services are tailored to support your specific needs, ensuring you remain compliant and informed in a rapidly evolving regulatory landscape.
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