PMCF Activities: Advanced Evidence Generation for MDR-Compliant Device Monitoring PMCF activities are structured actions designed to generate continuous post-market clinical data for medical devices operating in real-world conditions. These activities include follow-up studies, registries, case series, user feedback programs, PMCF questionnaires, complaint trend analysis, and targeted clinical investigations. Each activity is selected based on device class, residual risk, innovation level, and evidence gaps identified in the CER. PMCF activities strengthen regulatory compliance under MDR by confirming long-term performance and detecting early safety signals. They also support re-certification, improve device design, and provide credible clinical evidence for global market expansion. Through systematic PMCF activities, manufacturers maintain ongoing vigilance and ensure their medical devices remain safe and clinically effective.
