Risk management should inform PMS and PMCF plans. Residual risks, uncertain controls, complaint trends, and clinical uncertainties are natural inputs for post-market monitoring.
The risk file should also support GSPR traceability. Safety and performance requirements often rely on risk controls, verification evidence, labelling, and clinical conclusions.
When post-market data reveals a new signal, feed it back into the risk file and related documents. A living risk process is easier to defend than a file that stops at launch.
Official references
This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.