This white paper explains how medical device manufacturers can modernize post-market surveillance by moving from complaint-driven monitoring to a proactive, integrated, patient-focused model. Under EU MDR, IVDR, and related rules, PMS must collect and analyze evidence from complaints, registries, literature, service records, surveys, and clinical follow-up. Findings should feed into risk management, clinical evaluation, labeling, CAPA, recalls, and design improvements. The paper stresses defined thresholds, data quality controls, signal escalation, and full traceability. It also shows how digital, AI-enabled systems can connect plans, risks, documents, and actions, helping firms detect issues early, reduce recalls, improve compliance, protect patients and strengthen commercial performance.

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