What is the “post-market surveillance system”?

The post-market surveillance system (PMS) serves to “collect, record and actively and systematically analyze the relevant data on the quality, performance and safety of a device during the entire validity period, to draw the necessary conclusions and to determine, implement and monitor any preventive and corrective actions” (Ref. Art. 83 of the MDR).

The need for such a system arises immediately after the device is marketed. The PMS system serves not only to meet regulatory requirements, but also to improve risk management and improve the quality of a medical device. The PMS system also serves to appropriately identify problems in the design and/or the use of the device and to accurately characterize the behavior of the device under normal conditions of use and the obtained clinical results.

Post-market surveillance system

Vigilance is also part of the PMS system. Post-market clinical follow-up (PMCF, for medical devices) and post-market performance follow-up (PMPF, for IVDs) are “living” parts of the PMS system and fundamental elements of the QMS, continuos processes that are part of the clinical/performance evaluation aimed at bridging the gap between the evidence gathered during the pre-market phase and the PMS data collected with the device already in use.

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