Clinical Evaluation Report

Summary

A clinical evaluation report documents your systematic analysis of clinical evidence demonstrating your device’s safety and clinical performance. This comprehensive document presents your literature review findings, equivalence analysis, and clinical data evaluation to support regulatory approval and ongoing market compliance.

Why is Clinical Evaluation Report important?

The clinical evaluation report serves as primary evidence for regulatory authorities that your device meets safety and performance requirements under EU MDR Article 61 and FDA regulations. This document directly supports your CE marking application, 510(k) submission, or other regulatory pathways by demonstrating clinical evidence adequacy. Regulators use this report to assess whether your device achieves its intended clinical benefits while maintaining an acceptable benefit-risk ratio. The report also establishes the foundation for post-market clinical follow-up activities and provides evidence for General Safety and Performance Requirements (GSPR) compliance. Without a robust clinical evaluation report, you cannot demonstrate regulatory compliance or justify market access.

Regulatory Context

Under 21 CFR Part 820 and FDA guidance documents:

Clinical evaluation report supports 510(k) substantial equivalence determination
Must demonstrate safety and effectiveness through appropriate clinical evidence
Predicate device comparison requires detailed clinical performance analysis
Literature review and clinical data analysis must follow FDA guidance standards

Special attention required for:

Software medical devices requiring algorithm validation data
Novel devices without adequate predicate devices requiring clinical studies
Class III devices requiring Premarket Approval (PMA) with clinical trial data
AI/ML devices requiring real-world performance validation

Guide

Your clinical evaluation report must present a comprehensive and objective analysis of all available clinical evidence supporting your device’s safety and clinical performance. The report serves as the definitive document demonstrating regulatory compliance and clinical adequacy.

Device Information and Clinical Claims

Begin with detailed device characterization including technical specifications, intended purpose, patient population, and use environment. Document all clinical claims and benefits your device provides, ensuring alignment with your intended use statement. Present your device classification and regulatory pathway, as these determine the evidence standards your report must meet.

Literature Review and Analysis

Present your systematic literature search results following your clinical evaluation plan methodology. Document search strategies, databases queried, and inclusion/exclusion criteria applied. Analyze retrieved literature using structured appraisal criteria, categorizing evidence by relevance to your device, equivalent devices, and state of the art. Present evidence tables summarizing key findings from relevant publications, including study design, patient populations, clinical outcomes, and relevance scores.

Equivalence Demonstration

If claiming equivalence, provide detailed technical, biological, and clinical comparison between your device and the equivalent device. Present comparison tables addressing all relevant characteristics per MDCG 2020-5 requirements. Justify any differences and demonstrate they don’t affect clinical safety or performance. Document the equivalent device’s clinical history and regulatory status to support your equivalence claim.

State of the Art Analysis

Analyze the current clinical landscape for your device’s intended use, including existing treatment options, clinical standards, and competing technologies. Compare your device’s performance against established benchmarks and demonstrate how it fits within or advances current clinical practice. This analysis supports your benefit-risk assessment and clinical positioning.

Pre-Clinical and Clinical Data Integration

Integrate relevant verification and validation data, usability testing results, and any clinical investigation findings. Present how pre-clinical testing supports your clinical claims and addresses identified risks. Document any biocompatibility, electrical safety, or performance testing results that contribute to clinical evidence.

Post-Market Data Analysis

Present findings from vigilance database searches and any available post-market surveillance data. Analyze safety signals, adverse events, and performance issues reported for your device, equivalent devices, and similar technologies. Demonstrate how this data informs your benefit-risk assessment and clinical conclusions.

Benefit-Risk Analysis

Conduct a comprehensive benefit-risk assessment weighing your device’s clinical benefits against identified risks. Present evidence supporting each claimed benefit and demonstrate risk acceptability based on clinical evidence. Address how your device’s benefit-risk profile compares to existing treatment options and meets GSPR requirements.

Clinical Conclusions and GSPR Compliance

Present clear clinical conclusions regarding your device’s safety and clinical performance based on all evaluated evidence. Demonstrate compliance with relevant GSPRs, particularly GSPR 1, 2, 6, and 8. Document any evidence gaps and plans for addressing them through post-market activities.

Post-Market Clinical Follow-Up Planning

Outline your PMCF strategy based on clinical evaluation findings, including specific clinical questions requiring ongoing monitoring. Plan data collection methods, timelines, and success criteria for post-market clinical activities.

Example

Scenario: You’ve completed the clinical evaluation for your StressMonitor Pro mobile app that analyzes heart rate variability for stress assessment. Your report documents literature review findings, equivalence to HeartWatch Pro, and clinical conclusions supporting Class IIa classification.