Post-Market Surveillance (PMS)
A systematic process for collecting, analyzing, and acting on information about medical devices after they have been placed on the market. PMS is a regulatory requirement under EU MDR, FDA regulations, and most international frameworks.
Post-Market Surveillance (PMS) is the proactive and systematic process by which manufacturers gather and evaluate experience from devices that have been placed on the market. The goal is to identify any need to apply corrective or preventive actions, update the benefit-risk assessment, and ensure continued safety and performance throughout the device's lifecycle.
PMS under EU MDR
EU MDR significantly strengthened PMS requirements compared to the prior MDD. Manufacturers must establish a PMS system proportionate to the risk class and type of device. This includes a PMS plan, periodic safety update reports (PSUR) for Class IIa/IIb/III devices, a post-market clinical follow-up (PMCF) plan, trend reporting, and vigilance reporting for serious incidents. PMS data feeds back into the clinical evaluation and risk management processes.
PMS and procurement decisions
Procurement teams increasingly consider a manufacturer's PMS track record when evaluating tenders. Evidence of robust PMS — including low incident rates, timely field safety corrective actions, and comprehensive safety update reports — demonstrates a commitment to product quality and patient safety that influences tender scoring.