Glossary · EU in vitro diagnostics: IVDR
Performance evaluation (IVDR)
Also known as: Performance evaluation report (PER), IVDR performance evaluation
Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, performance evaluation is the assessment and analysis of data to establish or verify the scientific validity, the analytical performance and, where applicable, the clinical performance of a device. It follows Article 56 and Annex XIII, is documented in a performance evaluation report and is updated throughout the device’s life.
- EU
- IVDR
- Technical documentation
In one sentence
IVDR performance evaluation under Article 56 and Annex XIII: evidence of scientific validity, analytical performance and clinical performance for an IVD.
Example
For a troponin assay, the manufacturer shows scientific validity from published literature on troponin and myocardial infarction, analytical performance from its own precision and detection-limit studies, and clinical performance from a study of sensitivity and specificity in emergency patients.
How it applies
- Scientific validity: The association of the analyte with a clinical condition or physiological state, shown from literature, consensus guidelines or studies.
- Analytical performance: The ability to correctly detect or measure the analyte: for example trueness, precision, analytical sensitivity and specificity, measuring range and interference.
- Clinical performance: The ability to yield results that correlate with the clinical condition in the target population and intended user: for example diagnostic sensitivity and specificity and predictive values. Where clinical performance data are not required, the manufacturer justifies this.
- Plan and report: A performance evaluation plan defines the approach and the state of the art benchmarks; the performance evaluation report sets out the evidence and the conclusion on the benefit-risk ratio. MDCG 2022-2 describes the general principles of clinical evidence for IVDs.
- Updates: Data from PMPF and post-market surveillance update the evaluation. For class C and D devices, the summary of safety and performance (SSP) reflects it.
- Technical documentation: The performance evaluation report is part of the Annex II technical documentation and shows how the performance-related GSPR are met.
Performance evaluation vs. clinical evaluation
The MDR clinical evaluation asks whether a device is safe and achieves its clinical benefit in or on patients. The IVDR performance evaluation asks whether the test result is scientifically meaningful, analytically correct and clinically accurate; the benefit reaches the patient indirectly, through decisions based on the result. The terms are not interchangeable.