Post-market surveillance of medical devices
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Post-market surveillance gathers and evaluates information about a device after it reaches the market. The parts divide by surveillance activity and its documents or evidence: vigilance and recalls, periodic reports, clinical follow-up, and real-world evidence. Clinical evaluation, the wider device regulatory framework and its databases, and safety reporting for medicines belong to neighbouring concerns.
- Device vigilance, incident reporting and recalls — surveillance duties and the vigilance system, reporting and underreporting of incidents, and recalls by manufacturers and authorities
- Periodic safety update and post-market surveillance reports for devices — reports by device class, the 2022 draft guidance and its difficulties, workload and proposed automation of authoring
- Post-market clinical follow-up — its place in surveillance, the plan, studies, registries and user surveys, the evaluation report, and alignment with other device documents
- Real-world evidence for medical devices — evidence gaps, data sources and examples, EU and US frameworks, diagnostic-device collaboration, statistical endpoints and AI-driven meta-analysis