Understanding Post-Market Clinical Follow-up Requirements
Post-Market Clinical Follow-up (PMCF) is a systematic collection and analysis of clinical data on marketed medical devices to verify or identify any adverse effects and monitor device performance in real-world conditions.
Mandatory under EU MDR for most medical devices. Required to demonstrate ongoing safety and clinical performance throughout the device lifecycle and support CE marking maintenance.
Provides competitive advantage through real-world evidence, supports market expansion, enables device improvements, and demonstrates commitment to patient safety and regulatory compliance.
Clear definition of PMCF goals, target population, device indication, and specific safety/performance parameters to be monitored post-market.
Specification of data sources including clinical investigations, surveys, registries, real-world evidence, and adverse event reporting systems.
Detailed study protocol including patient population, endpoints, data collection frequency, duration, and statistical analysis methods.
Integration of risk analysis findings with PMCF strategy. Identification of specific risks requiring post-market monitoring and mitigation approaches.
Defined schedule for data collection, analysis, and reporting. Clear milestones for plan execution and regulatory submission timelines.
Specification of periodic PMCF reports, update frequency, responsible parties, and escalation procedures for safety signals or performance concerns.
