MDCG Guidance on post-market surveillance of Medical Devices and In Vitro Diagnostic Medical Devices
In its last publication of 2025, MDCG 2025-10, the Medical Device Coordination Group (MDCG) provides guidance to manufacturers concerning the post-market surveillance (PMS) obligations imposed by the Medical Devices Regulation (MDR) and the in vitro diagnostics Medical Devices Regulation (IVDR) and the appropriate steps to ensure that these are fulfilled.
The Guidance recalls that PMS is a continuous process which manufacturers must undertake throughout the lifetime of a medical device. The intention is to ensure ongoing monitoring of the safety, quality, and performance of the device. Among the elements that the Guidance advises manufacturers take into account are:
The PMS system must be suited to the active and systematic gathering, recording, and analysis of relevant data concerning the quality, performance, and safety of a device throughout its lifetime. They System must also enable the manufacturer to draw necessary conclusions and support determination, implementation, and monitoring of any preventive or corrective actions. The Guidance adds that it is in the manufacturer’s interest to use the PMS data to identify options to improve the usability, performance, and safety of the device. The Guidance includes a high-level overview of the PMS as an integral part of the manufacturer’s QMS;
Preparation of PMS plans should begin during the development of each medical device or group of medical devices. As part of this procedure, manufacturers should determine which activities are to be carried out to permit the systematic and proactive collection of experience gained from devices they place on the market or put into service. The chosen methods should be appropriate and based on the risk profile of the medical device. The rationale for selecting these methods should be documented and should include an explanation of how and by whom these methods are to be applied;
Manufacturers’ actions must be proactive, meaning that they should actively seek out available information and not merely wait for it to arrive through channels such as complaints. Actions should include actions specifically intended to gather or generate information from a variety of sources, including customer surveys, clinical experience, user feedback, screening of scientific literature, other clinical data sources, meta-analyses of published clinical data, evaluation of suitable registers, and post-market studies. The Guidance includes a table summarising the elements to be included in the PMS plan reflecting the related obligations provided in the MDR and IVDR;
Manufacturers are responsibility for selection of the most appropriate methods, parameters, values, processes, and tools for PMS depending on the type of the device. The Guidance includes a table providing an explanation of each indent of Section 1(a) of Annex III of both the MDR and the IVDR, the information that should be collected, and how this should be used;
Conclusions should be drawn based on an analysis of the data collected. These conclusions, and subsequently actions must be documented either, in the PMS report or in the PSUR. The Guidance includes a table providing examples demonstrating the various elements and interactions of a post-market surveillance system with other key aspects of the quality management system.
The Guidance specifically excludes the preparation of periodic safety update reports (PSUR) and post-market surveillance reports from its scope. Neither does it include the requirements related to the health institution exemption provided in Article 5.5 MDR and IVDR (in-house devices).