Clinical Evaluation Plan

Summary

A clinical evaluation plan establishes your systematic approach to gathering, analyzing, and evaluating clinical evidence that demonstrates your device’s safety and clinical performance. This document outlines your methodology for literature searches, equivalence analysis, and clinical data collection to support regulatory compliance and market access.

Why is Clinical Evaluation Plan important?

Clinical evaluation is mandatory under EU MDR Article 61 and serves as the foundation for demonstrating that your device achieves its intended clinical benefits while maintaining an acceptable benefit-risk ratio. Regulators require this systematic approach to ensure you’ve thoroughly assessed available clinical evidence before placing your device on the market. Without a robust clinical evaluation plan, you cannot demonstrate compliance with General Safety and Performance Requirements (GSPRs) or justify your device’s clinical claims. The plan also guides your post-market clinical follow-up activities and helps identify any gaps in clinical evidence that may require additional studies.

Regulatory Context

Under 21 CFR Part 820 and FDA guidance documents:

Clinical evaluation supports 510(k) predicate device comparison and substantial equivalence determination
Must demonstrate safety and effectiveness through appropriate clinical data
Clinical data requirements vary by device classification and risk level
Literature searches and predicate device analysis are standard approaches for Class II devices

Special attention required for:

Software medical devices requiring clinical validation of algorithms
Novel devices without adequate predicate devices
Devices with new indications for use requiring clinical studies
AI/ML devices requiring algorithm performance validation

Guide

Your clinical evaluation plan must establish a systematic and objective methodology for gathering and analyzing clinical evidence. The plan serves as your roadmap for demonstrating clinical safety and performance throughout your device’s lifecycle.

Device Information and Claims

Start by clearly defining your device description, intended purpose, and clinical claims. Your clinical evaluation scope must align precisely with your intended use statement and target patient population. Document your device classification, as this determines the level of clinical evidence required. Higher-risk devices require more extensive clinical data and may need clinical investigations rather than literature-based evaluations alone.

Clinical Development Strategy

Establish your clinical development pathway based on your device’s risk classification and novelty. For most software medical devices and Class I/IIa devices, literature-based evaluation combined with equivalence demonstration provides sufficient evidence. Document whether you’ll pursue equivalence to existing devices, conduct clinical investigations, or rely primarily on literature and state-of-the-art analysis.

Literature Search Methodology

Design your literature search using the PICO methodology (Patient, Intervention, Comparison, Outcomes) to ensure comprehensive coverage. Plan searches across PubMed and Cochrane Library using systematic keywords related to your device, equivalent devices, and the clinical condition. Establish clear inclusion and exclusion criteria for literature appraisal, including language restrictions, publication types, and relevance thresholds.

Equivalence Strategy

If claiming equivalence, identify potential equivalent devices that are CE-marked or FDA-cleared for similar indications. Plan your equivalence analysis across technical, biological, and clinical characteristics as required by MDCG 2020-5. Document how you’ll demonstrate that any differences between devices don’t affect clinical safety or performance.

Post-Market Data Integration

Plan your approach to vigilance database searches across FDA MAUDE, BfArM, and other international databases. Establish search keywords for your device, equivalent devices, and the state of the art. This data helps identify any safety signals or performance issues that could affect your clinical evaluation conclusions.

Clinical Evaluation Team

Assemble a team with appropriate clinical expertise in your device’s clinical area. Team members must have either a higher education degree with five years of professional experience or ten years of professional experience without a degree. Document team member qualifications and ensure declarations of interest to maintain objectivity.

Evidence Level Requirements

Plan your evidence collection based on MDCG 2020-6 evidence levels. For low-risk devices, Level 6 evidence (state of the art evaluation) and above typically suffices. Higher-risk devices may require Level 1-4 evidence from clinical investigations. Document your rationale for the evidence level you’re targeting.

Example

Scenario: You’re developing a mobile app that analyzes heart rate variability data to provide stress level assessments for wellness monitoring. The app is classified as Class IIa software and you plan to demonstrate equivalence to existing heart rate monitoring devices.