In December 2025, the Medical Device Coordination Group (MDCG) released a new guidance on post-market surveillance of medical devices and IVDs on the Union market. Guidance MDCG 2025-10 helps manufacturers understand and implement the post-market surveillance requirements according to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). In particular, the document explains what a compliant PMS system should look like, how to plan and execute it, and how it fits into other quality processes.
General PMS obligations for medical devices and IVDs
A post-market surveillance (PMS) system must continuously and proactively collect and analyse data on a device’s quality, performance, and safety throughout its entire lifecycle. It should allow manufacturers to draw conclusions and to plan, implement, and monitor preventive or corrective actions. In addition, PMS data should also be used to improve device usability, performance, and safety. PMS applies to all devices, including custom-made devices.
Importantly, the PMS system is closely integrated with the quality management system (QMS), particularly with risk management and clinical/performance evaluation.
PMS Plan and main activities of the PMS system
Under the MDR and IVDR, post-market surveillance must be based on a PMS plan (part of technical documentation, except MDR custom-made devices under the MDR). PMS planning begins during device development and should proactively define how post-market experience will be collected. A PMS plan applies to a device or a group of similar devices and defines the scope, monitoring activities, methods, frequency, and rationale, in line with the device’s risk and level of innovation. The plan should identify the applicable methods, with detailed procedures referenced separately where appropriate.
PMS must be proactive, meaning manufacturers actively seek information from multiple sources (e.g. user feedback, clinical data, literature, registries, post-market studies), not just complaints. The plan must also link PMS outputs to required reports (PMS report or PSUR, depending on device class). Manufacturers must identify appropriate post-market data sources based on the device, its users, and use conditions, choosing suitable methods and tools themselves. Data quality and reliability need to be ensured before analysis, as unreliable sources can lead to incorrect conclusions.
Collection of PMS data
Manufacturers must operate a robust PMS system that actively and systematically collects real-world data on device quality, performance, and safety throughout its lifecycle. Data collection begins once the device is compliant and placed on the market and includes complaints, user feedback, literature, and other third-party information. For higher-risk or novel devices, manufacturers may need to generate additional real-world data, often through PMCF or PMPF.
Collected data must be assessed and analysed against PMS objectives to confirm device performance, benefit–risk acceptability, and alignment with the state of the art. Data from multiple sources should be compared, quality-checked, and inconsistencies evaluated. Based on this analysis, manufacturers must draw conclusions and decide on preventive or corrective actions to ensure continued device safety and performance.
MDCG 2025-10 provides a summary of the elements to be covered in the PMS plan (page 8) as well as provides an overview of the information to collect (page 11). Lastly, the guidance provide an overview of the interactions of the PMS system with other key aspects of the QMS (page 15).
References:
European Commission (2025). MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025). Retrieved on 02/01/2025.
For any questions on compliance of medical devices, contact MDlaw Team here or at mdlaw@obelis.net.
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