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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.

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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.

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Regulatory Context

  • FDA
  • MDR
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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Clinical Evaluation Plan Structure

1. Device Information
  • Device: StressMonitor Pro mobile application v1.0
  • Classification: Class IIa medical device software
  • Intended Purpose: To analyze heart rate variability patterns and provide stress level assessments for adult users in home environments
  • Patient Population: Healthy adults aged 18-65 seeking stress monitoring
  • Clinical Claims: Accurately measures heart rate variability and correlates measurements with validated stress assessment scales
2. Clinical Development Strategy
  • Primary approach: Literature-based evaluation with equivalence demonstration
  • Equivalent device: HeartWatch Pro (CE-marked Class IIa HRV monitor)
  • No clinical investigation planned based on low-risk classification and available equivalent device
3. Literature Search Plan
  • PICO Framework:
    • P: Healthy adults, stress monitoring, heart rate variability
    • I: Mobile heart rate monitoring, HRV analysis software
    • C: Traditional stress assessment methods, other HRV devices
    • O: Stress level accuracy, user safety, clinical utility
  • Databases: PubMed, Cochrane Library, ClinicalTrials.gov
  • Keywords: “heart rate variability,” “stress monitoring,” “mobile health,” “HRV analysis,” “stress assessment”
4. Equivalence Analysis Plan
  • Technical: Similar HRV algorithms, comparable measurement accuracy, same data processing methods
  • Biological: No direct body contact (both use external sensors)
  • Clinical: Same intended population, similar stress assessment outputs, comparable clinical utility
5. Post-Market Data Plan
  • Vigilance searches: FDA MAUDE, BfArM databases
  • Keywords: Device names, manufacturer names, “heart rate monitor,” “stress monitor,” “HRV device”
  • Focus on safety signals related to false readings or user misinterpretation
6. Clinical Evaluation Team
  • Dr. Sarah Johnson, Cardiologist (15 years experience, MD from Johns Hopkins)
  • Dr. Michael Chen, Clinical Psychologist (8 years stress research, PhD Stanford)
  • Jane Smith, Biomedical Engineer (6 years medical device experience, MS Bioengineering)

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Q&A

A clinical evaluation plan and report assess the clinical performance and safety of your medical device. The plan establishes your methodology for gathering and analyzing clinical evidence, while the report documents your findings and conclusions. Together, they demonstrate that your device meets regulatory requirements and provides clinical benefits that outweigh any risks.
Your clinical evaluation team must include someone familiar with your device’s clinical field, with either a higher education degree and five years of relevant professional experience, or ten years of professional experience if a degree isn’t available. Team members must provide CVs and sign declarations of interest to ensure objectivity. The team should have expertise in your specific clinical area and understanding of medical device regulations.
Perform an initial literature search and review when creating your plan, then conduct an updated search closer to your document approval date to capture any newly published studies. This ensures your clinical evaluation reflects the most current available evidence. Plan for regular updates post-market based on new clinical data, safety signals, or changes to your device.
The approach depends on your device’s risk classification, novelty, and availability of equivalent devices. Most Class I and IIa devices can rely on literature-based evaluation with equivalence demonstration. Higher-risk devices, novel technologies, or devices without adequate equivalent devices typically require clinical investigations. Consult MDCG 2020-6 for specific evidence level requirements based on your device characteristics.
Search PubMed for biomedical literature and Cochrane Library for systematic reviews and clinical trials. Also search ClinicalTrials.gov for ongoing or completed clinical studies. For post-market data, search FDA MAUDE, BfArM, and other vigilance databases. Use systematic search strategies with appropriate keywords related to your device, equivalent devices, and clinical condition.