What should the PMCF plan cover?
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 plan and performed under a documented PMCF plan.
The technical documentation may instead contain a justification that is not applicable, but the MDR does not create a blanket class-based exemption. The justification must be specific to the device and its clinical evidence, residual risks, expected lifetime, uncertainties, and post-market questions; where a notified body is involved, its clinical-evaluation assessment covers that non-performance justification.
The plan should identify the device and covered variants, intended purpose, users, patient population, indications, contraindications, warnings, classification, expected lifetime, and the 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, 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 guidance where they support the plan.
What should an EU MDR plan and report cover?
The plan should specify the methods and procedures for proactively collecting and evaluating clinical data from the CE-marked device in use within its intended purpose. It should cover the device scope, PMCF objectives, planned general and specific activities, links to the clinical evaluation report and risk management file, relevant standards or guidance, and a justified schedule for analysis and reporting. PMCF is part of the plan, and the notified body also assesses the manufacturer's procedures and documentation for PMCF, including the justification if PMCF is not performed. The PMCF evaluation report should analyse the PMCF findings and feed the clinical evaluation report, risk management, PMS outputs, and technical documentation.
How does connect to reports and PSURs?
is addressed in the plan. For class I devices, the PMS report summarizes analysis of PMS data and related preventive or corrective actions. For class IIa, IIb, and III devices, the PSUR must summarize PMS data and include the main findings of PMCF, conclusions of the benefit-risk determination, sales volume, population using the device, and usage frequency where practicable.
Can a manufacturer decide that is not applicable?
The MDR allows the technical documentation and plan to contain a justification that is not applicable instead of a PMCF plan. The justification must address the specific device and explain why the available clinical evidence, residual risks, expected lifetime, and post-market uncertainties do not require proactive post-market clinical data collection. It is not an automatic exemption for class I or established devices, and a notified body reviews the justification where notified-body conformity assessment applies.
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.