Performance evaluation — IVDR
IVDR Art. 56 and Annex XIII. Performance evaluation for IVDs is the IVDR equivalent of clinical evaluation under MDR. It is mandatory for all IVD classes and must be maintained as a continuous lifecycle process.
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
What is performance evaluation?
A performance evaluation is the assessment and analysis of data to establish or verify the analytical and, where applicable, clinical performance of an IVD. It encompasses the full body of evidence demonstrating that the device:
- Achieves its intended analytical performance (sensitivity, specificity, accuracy, precision, etc.)
- Achieves its intended clinical performance (diagnostic sensitivity/specificity, positive/negative predictive values)
- Is safe for its intended use
- Meets its claimed performance specifications across the intended use settings and populations
Performance evaluation vs. clinical evaluation
Performance evaluation is analogous to MDR clinical evaluation but adapted for the in vitro context:
| Aspect | MDR clinical evaluation | IVDR performance evaluation |
|---|---|---|
| Focus | Device safety and clinical performance in patient use | Analytical and clinical performance of the IVD |
| Key evidence types | Clinical investigations, literature | Analytical studies, clinical performance studies, literature |
| Regulatory basis | Art. 61, Annex XIV | Art. 56, Annex XIII |
| Post-market follow-up | PMCF (Annex XIV Part B) | PMPF (Annex XIII Part B) |
Performance characteristics — key definitions
Analytical performance
Characterises how the device performs as a measurement or detection system, independent of the clinical context:
| Parameter | Definition |
|---|---|
| Analytical sensitivity | Lowest detectable amount of analyte (detection limit, LoD) |
| Analytical specificity | Ability to detect only the intended analyte; freedom from cross-reactivity and interference |
| Accuracy (trueness) | Closeness of test results to the true value |
| Precision | Repeatability (within-run) and reproducibility (between-run, between-lab) |
| Linearity | Range over which results are proportional to analyte concentration |
| Measuring range | Range of analyte concentrations the device can reliably measure |
| Interference | Effect of potentially interfering substances (haemolysis, lipaemia, medications) |
| Stability | Reagent/calibrator stability; specimen stability |
Clinical performance
Characterises how well the device's results relate to clinical outcomes or established reference methods:
| Parameter | Definition |
|---|---|
| Diagnostic sensitivity | Proportion of true positives correctly identified (TP / (TP + FN)) |
| Diagnostic specificity | Proportion of true negatives correctly identified (TN / (TN + FP)) |
| Positive predictive value (PPV) | Probability that a positive result is a true positive (varies with prevalence) |
| Negative predictive value (NPV) | Probability that a negative result is a true negative (varies with prevalence) |
Annex XIII — performance evaluation stages
Part A — Pre-market performance evaluation
Stage 1: Scientific validity of the analyte
- Is there a well-established association between the analyte and the clinical condition?
- What is the evidence base for the analyte's clinical utility?
Stage 2: Analytical performance studies
- Laboratory studies establishing the analytical performance characteristics listed above
- Typically conducted under controlled laboratory conditions
- Must follow CLSI (Clinical and Laboratory Standards Institute) or equivalent validated protocols
Stage 3: Clinical performance studies (where required)
- Studies in the intended patient population confirming diagnostic sensitivity/specificity
- Required when analytical performance alone cannot demonstrate clinical performance
- More rigorous for Class C and D devices
- For companion diagnostics: clinical performance linked to the therapeutic product's clinical trials
The output is a Performance Evaluation Report (PER) — the IVDR equivalent of the CER.
Part B — Post-market performance follow-up (PMPF)
Ongoing collection and analysis of post-market performance data. See Post-market performance follow-up.
Performance studies — a note
A performance study in the IVDR context is a study conducted on specimens derived from subjects specifically to evaluate the performance of an IVD. Performance studies are regulated under IVDR Art. 57–77 and Annex XIV.
Key distinctions:
- Interventional performance studies: involve additional invasive procedures to collect specimens beyond standard of care → highest regulatory oversight
- Non-interventional studies: use specimens collected as part of standard care (retrospective or prospective) → lighter oversight
Performance studies must be registered in EUDAMED.
Common Specifications for IVDs
For certain IVD categories, the European Commission has published or is developing Common Specifications (CS) that define specific analytical performance requirements. Where CS exist, manufacturers must comply or justify an equivalent approach. CS have been prioritised for:
- High-risk Class D analytes
- Companion diagnostics
- Specific near-patient and self-test formats
Related pages
- Clinical evaluation overview (MDR)
- Performance studies
- Using international clinical data
- Companion diagnostics
- Near-patient & self-test IVDs
Official references
| Reference | Description |
|---|---|
| IVDR Art. 56 | Performance evaluation requirements |
| IVDR Annex XIII | Performance evaluation — detailed framework |
| IVDR Art. 57–77 | Performance studies |
| IVDR Annex XIV | Performance study requirements |
| MDCG 2022-9 | Performance evaluation guidance |
| MDCG 2020-16 | Companion diagnostic performance evaluation |