Clinical Evaluation Plan vs Clinical Evaluation Report

The Clinical Evaluation Plan describes how the manufacturer will evaluate clinical evidence: scope, objectives, methods, data sources, appraisal criteria, and how the evidence will support safety and performance claims.

The Clinical Evaluation Report documents the actual evaluation. It should explain the evidence considered, the appraisal of that evidence, the conclusions reached, and any limitations or residual gaps.

Keep the plan and report aligned. If the evaluation deviates from the plan, the report should explain why and what effect the deviation has on the reliability of the conclusion.