Post-market surveillance under MDR hinges on a clear plan that links real-world data to risk controls and clinical evidence. Use this outline to build or refine your PMS and PMCF plans.
1) Scope and objectives
- Device identification, intended purpose, risk class, and variants.
- PMS objectives tied to safety, performance, and benefit-risk profile.
- Roles, responsibilities, and escalation paths.
2) Data sources and collection cadence
- Complaints, vigilance, trend reports, and field safety corrective actions.
- Literature, registries, real-world data partners, and user feedback programs.
- Service/maintenance logs and manufacturing quality signals (NC/CAPA).
- Collection cadence and sampling approach by market/region.
3) Indicators and thresholds
- Safety: incident rates, severity mix, new hazards, and near misses.
- Performance: key functional KPIs, usability signals, and reliability metrics.
- Trend analysis rules (per MDCG) and statistical methods for early detection.
- Triggers for CAPA, FSCA, labeling updates, and PMCF initiation/expansion.
4) PMCF plan (when warranted)
- Specific questions the PMCF will answer (residual risk, long-term safety, usability).
- Study design, endpoints, sample size rationale, and timelines.
- Data management, monitoring, and bias mitigation.
- Integration with CER updates and risk management file.
5) Reporting and governance
- PSUR/SSCP updates cadence and owners.
- Management review inputs and decision logs.
- Communication to economic operators and NB interactions.
How MedReg AI helps
- Identify PMS gaps by mapping your plan to MDR Annex III expectations.
- Trace risk controls to PMS indicators and automate evidence collection checklists.
- Generate a concise PMS/PMCF gap report before NB interactions.
Ready to operationalize PMS? Run a gap analysis and share it with your QA/RA leads. If you need pricing, see /pricing; for help, visit /contact.
