Clinical Evaluation Report (CER) Guide

The clinical evaluation plan

• The GSPRs that require clinical data
• The intended purpose, target groups, indications and contraindications
• Intended clinical benefits with relevant and specified outcome parameters
• Methods to examine qualitative and quantitative aspects of clinical safety, including residual risks and side effects
• Parameters to determine the acceptability of the benefit-risk ratio, based on the state of the art
• How benefit-risk issues relating to specific components will be addressed
• A clinical development plan, from exploratory investigations to PMCF

Sources of clinical data

Clinical investigations of the device itself, clinical data on an equivalent device, published literature, PMS and PMCF data, and, where justified, other sources. For Class III and implantable devices, Article 61(4) requires clinical investigations unless the conditions for an exemption are met.

Literature search and appraisal

Define the search question, databases, search strings, date limits and inclusion and exclusion criteria in a protocol. Record the number of records identified, duplicates removed, screened, excluded and included, often in a PRISMA-style flow. Appraise each included paper for relevance to the device and indication and for methodological quality, and record the weighting.

Equivalence

Annex XIV Part A Section 3 requires technical, biological and clinical characteristics to be similar to the extent that there is no clinically significant difference in safety and clinical performance. MDCG 2020-5 explains how to show this. Each characteristic should be compared in a table with a justification for every difference.

Sufficiency and conclusions

The analysis must state whether the data are sufficient in amount and quality to demonstrate conformity with the relevant GSPRs, whether the benefit-risk ratio is acceptable compared with the state of the art, and whether the IFU, label and risk management documentation are consistent with the findings. Gaps lead to PMCF activities or, if serious, to further investigations before certification. MDCG 2020-6 gives guidance on sufficient clinical evidence for legacy devices.

Updates

Article 61(11) requires the clinical evaluation to be updated throughout the lifecycle with PMCF data. For Class III and implantable devices, the PMCF evaluation report and, where indicated, the SSCP (Article 32) are updated at least annually.

How MDRpilot supports clinical evaluation

MDRpilot structures the CEP from the product record, runs literature searches in PubMed and Europe PMC and records PRISMA-style counts, holds the equivalence comparison, keeps a clinical gap matrix that informs the PMCF plan, adds confirmed clinical evidence files to the CER context and routes the CER through review and approval. The evaluator remains responsible for appraisal and conclusions.