Performance evaluation (Article 56 and Annex XIII) is the IVDR’s equivalent of clinical evaluation for medical devices. It is where manufacturers prove that a test does what they claim, and it is often the largest piece of work in an IVDR project.
Three pillars of evidence
| Pillar | Question | Typical evidence |
|---|---|---|
| Scientific validity | Is the analyte or marker associated with the clinical condition? | Literature, guidelines, consensus statements, own studies |
| Analytical performance | Does the device correctly detect or measure the analyte? | Accuracy, precision, sensitivity, specificity, limit of detection, measuring range, interference, cross-reactivity, stability |
| Clinical performance | Does the result correlate with the clinical condition in the target population? | Diagnostic sensitivity and specificity, predictive values, likelihood ratios, clinical performance studies, literature, routine diagnostic data |
Key documents
- Performance evaluation plan: intended purpose, target population, state of the art, performance characteristics, and the methods and acceptance criteria to be used
- Performance evaluation report: the evidence and conclusions, linked to the general safety and performance requirements
- Summary of safety and performance: required for Class C and D devices and made public via EUDAMED
Performance studies
Where existing data is not enough, manufacturers run performance studies. Studies involving invasive specimen collection or that affect patient management require authorization or notification and must meet ethical and data protection requirements. Leftover specimen studies are often used to generate clinical performance data efficiently.
A living document
Performance evaluation does not end at certification. It must be updated throughout the device’s life using post-market performance follow-up data, at least annually for Class C and D devices.
Tips for software and genomics
- Define the intended purpose precisely, including variant types, genes or panels and the clinical context
- Benchmark against recognized reference materials and truth sets
- Show performance across the full workflow, not just isolated algorithms
- Document how database and knowledge base updates are validated
IVDR guide
Overview · Scope and Key Definitions · Risk Classification · Conformity Assessment and Notified Bodies · Performance Evaluation · Technical Documentation · Post-Market Surveillance and Vigilance · Economic Operators, UDI and EUDAMED · Transition Deadlines and Reform
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For general information only; not legal or regulatory advice. Regulations and deadlines change, so confirm current requirements with your notified body or regulatory counsel. Last updated October 2026.