A PMCF Plan defines how clinical data will continue to be collected after market placement. The activities should match the device’s claims, clinical evidence, risk profile, and unresolved questions.
Examples include user surveys, registry participation, observational follow-up, literature monitoring, targeted studies, complaint trend analysis, or review of real-world performance data.
The plan should explain objectives, methodology, timelines, acceptance criteria, responsibilities, and how results update the CER, risk file, PMS reports, and labelling if needed.
Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.