- Published
- Updated
- Sources checked
The PMCF report should explain what was learned and what changes, including when activities underperformed.
PMCF evaluation reports — Define the regulatory scope
MDR Annex XIV Part B links PMCF findings with clinical evaluation. MDCG 2020-8 provides a report structure covering activities, results and documentation impact.
PMCF evaluation reports — Build the working record
Compare planned activities with completed work, recruitment, follow-up and missing data. For each finding, document its credibility, limitations and impact on the clinical evaluation, risk file and applicable public summary.
PMCF evaluation reports — Check before release
- Explain deviations from the PMCF plan.
- Include unfavourable findings and incomplete follow-up.
- Track each affected document to a decision.
PMCF evaluation reports — Record the decision and handover
Approve an action log with owners and revision targets. If evidence remains insufficient, revise the PMCF approach or claims rather than describing an incomplete activity as successful simply because it ended.
Frequently asked questions
- Does the report only list completed studies?
- No. It evaluates findings, limitations, deviations and consequences for the device evidence.
- Must every finding change the label?
- No. Assess the finding and document the justified impact or absence of impact.