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- Published
- Updated
A PMCF review reporting only new record counts may not show whether the clinical question has advanced. Treat periodic evaluation as a link between the original question, findings and a reasoned decision. Each period should inherit unresolved questions from the previous one.
Define the assessment
Explain the data-cut date, devices covered and periods of use. Distinguish new findings from continuing patterns. Check that risk assessment, clinical evaluation and follow-up planning interpret the same evidence consistently rather than independently closing each document with a green status.
Worked example
For example, one review identifies measurement loss and calls for additional data. The next report updates participant counts without revisiting the question. The team retrieves the open action, examines the relevant data subset and explains whether uncertainty decreased. Completion is judged by contribution to the question, not simply uploading a file.
Practical checks
- Assign an owner, expected evidence and rereview trigger to each unresolved question.
- Compare the new period’s scope with the previous data cut and explain changes.
- Link decisions to relevant risk and clinical-evaluation updates.
Decision and limitations
Closure should distinguish resolved uncertainty from what remains. More data alone do not establish sufficient evidence. If collected information cannot answer the question, authorised reviewers reconsider the method or scope; an open issue should not disappear without explanation.
Frequently asked questions
- Is an action complete when a file is uploaded?
- Assess acceptance of the evidence and its contribution to the question; upload is only a process step.
- Can review be skipped if no new data arrive?
- The reason for absent data and its impact on open questions also require assessment.