A PMS Plan explains how the manufacturer will collect, review, and act on post-market information. It should cover data sources, responsibilities, methods, frequency, escalation criteria, and links to risk management and clinical evaluation.
Useful data sources can include complaints, vigilance, service records, sales and distribution data, user feedback, literature, registry data, surveys, PMCF, trend reports, and competitor or state-of-the-art monitoring.
Make the plan operational. A list of possible sources is not enough; the plan should say who reviews them, how often, what triggers action, and how conclusions are documented.
Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.