What should the PMCF plan cover?
PMCF is a continuous process that updates the clinical evaluation under Article 61 and Annex XIV, Part B. It must be addressed in the manufacturer's PMS plan and performed under a documented PMCF plan.
The plan should identify the device and covered variants, intended purpose, users, patient population, indications, contraindications, warnings, classification, expected lifetime, and the PMCF objectives for that device. It should also reference the clinical evaluation report and risk management file so the post-market clinical questions being followed are clear.
- Define general methods such as clinical experience review, user feedback, scientific literature screening, and other clinical-data sources.
- Define specific methods where needed, such as suitable registries, PMCF studies, real-world evidence analyses, healthcare-professional surveys, patient or user surveys, and case-report review.
- For each activity, state the source of the need, objective, rationale, known limitations, data quality expectations, endpoints or analysis approach, and justified schedule for analysis and reporting.
- Reference applicable common specifications, harmonised standards used by the manufacturer, and PMCF guidance where they support the plan.
Binding MDR source for Article 61, Article 83-86, Annex III, and Annex XIV Part B requirements on clinical evaluation, PMS, PMCF planning, PMCF reports, PSUR content, and technical documentation.
MDCG template source for PMCF plan sections, device description, PMCF methods and activities, links to the clinical evaluation report and risk management file, equivalent or similar device data, standards or guidance references, and report timing fields.