Post-market surveillance (PMS) is the systematic process by which a manufacturer proactively collects and reviews experience gained from devices already on the market, in order to identify any need for corrective or preventive action. Under EU MDR it is a formal, planned obligation rather than a reactive complaints process, and it is one of the areas where the regulation raised expectations most sharply.
The underlying rationale is straightforward. Pre-market evidence is generated in controlled conditions with selected users and selected patients. Real-world use exposes the device to a wider population, less experienced users, different workflows and longer follow-up, so problems that were invisible before launch can become apparent afterwards.
Every manufacturer must have a PMS plan proportionate to the device's risk. Class I devices produce a PMS report, while Class IIa and above produce a Periodic Safety Update Report (PSUR) summarising surveillance findings, the benefit-risk conclusion, sales volumes and the characteristics of the population using the device. For higher classes the PSUR is reviewed by the Notified Body.
Post-market clinical follow-up (PMCF) is the clinical arm of surveillance. It is a planned, continuous process to confirm safety and performance over the device's expected lifetime, detect previously unknown side effects and check that the benefit-risk balance holds in routine use. A PMCF plan should target the specific residual uncertainties identified in the clinical evaluation, and a stated justification is required if a manufacturer concludes that PMCF is not applicable.
Surveillance has value only if it feeds back. Findings must update the risk management file, the clinical evaluation, the instructions for use and, where necessary, the design itself. Where a trend indicates a safety issue, the manufacturer must report it and may need to issue a field safety corrective action.
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