Post-market surveillance
Short definition
Post-market surveillance is the set of activities through which the manufacturer systematically and proactively collects and reviews experience gained with devices already on the market, to identify any need for corrective action.
In plain language
It is defined in Article 2, point 60, and regulated from Article 83 of Regulation (EU) 2017/745 onwards. Each manufacturer must have a surveillance plan proportionate to the device's class and risk; for Class I, the results are summarised in a post-market surveillance report. It is distinct from vigilance in the narrow sense, which deals with reporting serious incidents and field safety corrective actions.