Post-Market Clinical Follow-Up (PMCF)

Post-Market Clinical Follow-Up (PMCF) is a proactive process of collecting clinical data on a marketed device to confirm its safety and performance over time. PMCF is required for Class IV devices and for Class III devices where clinical evidence was based on equivalence or limited clinical data.

PMCF activities may include:

• Follow-up of patients who received the device as part of the Registro clinical investigation;
• Prospective clinical registries;
• Post-market clinical studies; and
• Systematic review of published post-market literature.

PMCF findings must be incorporated into the annual PMS report and, where significant, may trigger a Petição de Alteração.

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.