PMS Management of Medical Devices and IVDs in the European Union (EU)
One may think that placing a medical device on the market is the final step; however, even after the device’s launch, the manufacturer is required to fulfill the Post-Market Surveillance (PMS) requirements. PMS involves activities to collect and evaluate the feedback/complaints related to the quality, performance, and safety of the devices, user surveys, technical and clinical watch, surveillance of competing devices throughout the device’s lifetime and take any corrective actions if necessary.