Clinical Evaluation Report Template

Start the CER with the exact device scope under review. Identify the legal manufacturer, device name, model or version, Basic UDI-DI if available, risk class, classification rule, accessories or system components in scope, and the technical documentation references that connect the CER to the design file.

Record the intended purpose in the same terms used across the IFU, labelling, claims, clinical evaluation plan, risk file, PMS plan, PMCF plan, and any SSCP. The MDR definition ties intended purpose to the manufacturer's supplied data and the clinical evaluation, so inconsistencies here should be treated as review findings rather than editorial differences.

Add a matrix that links each clinically relevant GSPR, claim, residual risk, side-effect, contraindication, and warning to the clinical evaluation plan and the evidence used in the CER. The reviewer should be able to see why clinical data are needed, what acceptance criteria were used, and how the conclusion affects the benefit-risk determination.

For each indication and intended purpose, define the state-of-the-art comparator or clinical care context, measurable clinical outcome parameters, expected clinical benefits, known and foreseeable risks, and the threshold used to conclude that the benefit-risk ratio remains acceptable.

Use separate CER tables for identified data, excluded data, and appraised data. MDR Annex XIV expects available clinical data and evidence gaps to be identified through a systematic scientific literature review, then appraised for suitability before the CER reaches conclusions about safety, clinical performance, and clinical benefits.

The appraisal table should treat favourable and unfavourable data consistently. Do not hide complaints, vigilance findings, weak study design, missing subgroup evidence, unsupported outcomes, or data from non-equivalent devices; state how each limitation affects the conclusion or PMCF plan.

If the CER relies on clinical data from an equivalent device, include a device-by-device equivalence table. Do not blend characteristics from multiple devices to create a composite equivalent. Each claimed equivalent device needs its own clinical, technical, and biological comparison and its own conclusion.

The CER should identify differences first, then explain why they do not create a clinically significant difference in safety or clinical performance. If data access is insufficient, if the device is not actually equivalent, or if the evidence only relates to similar devices, use the data for state of the art, risk identification, endpoint selection, or PMCF planning rather than as equivalent-device evidence for conformity.

The CER should not treat PMCF as an appendix with no effect on conclusions. PMCF is a continuous process that updates the clinical evaluation and belongs in the PMS plan, the CER, and technical documentation. Include both the planned activities and the results already available.

Where PMCF is not planned or is limited, record the justification and the unresolved clinical questions that remain. Where PMCF results exist, state whether they confirm safety, performance, clinical benefit, residual-risk acceptability, intended purpose, and benefit-risk conclusions or whether corrective, preventive, claim, IFU, risk-file, or CER updates are needed.

Article 61 requires the clinical evaluation and its documentation to be updated throughout the device lifecycle with PMCF and PMS data. For class III and implantable devices, update the PMCF evaluation report and, if indicated, the SSCP at least annually. Record the actual CER review date and rationale as a controlled output rather than assuming that every device has the same fixed CER cycle.

End the CER with a conclusion that a decision-maker can use. The conclusion should say whether the clinical evidence is sufficient for the intended purpose and claims, whether relevant GSPRs are supported by clinical and non-clinical evidence, whether benefit-risk remains acceptable, and what questions must be answered through PMS or PMCF.

Add an approval block rather than leaving approval implicit. The MDR does not prescribe job titles or a signature format for a manufacturer's CER, so the QMS should define the author, evaluator, independent or cross-functional reviewers where used, competence evidence, documents reviewed, deficiencies, responses, next review trigger, and approval status. Do not present the notified body's MDCG 2020-13 assessment fields as mandatory manufacturer signoff fields.