IVDR Performance Evaluation: From Planning to Reporting

Performance evaluation under IVDR is significantly more comprehensive than under the previous directive. This guide covers the complete process from planning to final reporting.

The Three Pillars of Performance Evaluation

IVDR Annex XIII Part A establishes three key components:

• Scientific Validity: The association between an analyte and a clinical condition
• Analytical Performance: The device's ability to correctly detect or measure the analyte
• Clinical Performance: The device's ability to provide clinically meaningful results

Performance Evaluation Plan

Your PEP should document:

• Objectives and scope of evaluation
• Methodology for each performance component
• Acceptance criteria with scientific justification
• Statistical considerations
• Literature search strategy

Analytical Performance Studies

Key analytical characteristics to evaluate include:

• Sensitivity and specificity
• Precision and reproducibility
• Measuring range and linearity
• Interfering substances
• Cross-reactivity
• Stability studies

Clinical Performance Evidence

For most devices, clinical performance requires:

• Diagnostic sensitivity and specificity
• Positive and negative predictive values
• Likelihood ratios
• Expected values in normal and abnormal populations

Performance Evaluation Report

The final PER should synthesize all evidence, clearly state conclusions against pre-defined acceptance criteria, and address any limitations or gaps in the data.