Post-market reporting requirements depend on the device, regulation, class, and applicable route. Some devices require PMS reports; higher-risk devices may require periodic safety update reporting.
Complya can help draft reporting structures, but the expert confirms the applicable route and cadence for the case before delivery.
Keep report inputs current: complaints, incidents, trend analysis, sales volume, benefit-risk conclusions, CAPA links, PMCF results, and any changes to clinical or risk conclusions.
Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.