Performance evaluation (IVDR)
Performance evaluation is the IVDR framework for demonstrating that an IVD is safe and performs as intended. It covers scientific validity, analytical performance and clinical performance, and it must remain up to date over the lifecycle.
What performance evaluation includes
Scientific validity
Evidence that the analyte/marker is associated with the clinical condition or physiological state you claim (including appropriate references and rationale).
Analytical performance
Evidence that the test measures the analyte reliably (e.g., sensitivity/specificity, LoD/LoQ, precision, interference, stability — depending on technology).
Clinical performance
Evidence that results are clinically relevant for the intended purpose and target population (often a major effort under IVDR).
Key documents (typical)
- Performance Evaluation Plan (PEP) — what evidence is needed and how it will be generated/compiled.
- Performance Evaluation Report (PER) — summary and assessment of scientific validity, analytical and clinical performance evidence.
- Supporting protocols, reports, literature searches, data analysis and traceability to claims.
- Links to risk management, labeling/IFU, and post‑market performance follow‑up (where applicable).
How we help
- Define/validate intended purpose wording and performance claims.
- Design the performance evidence strategy (what to generate vs what can be justified with literature).
- Review and structure performance documentation so claims map to evidence cleanly.
- Identify typical gaps early (especially for clinical performance).
- Prepare for Notified Body expectations and questions (where applicable).
Inputs we need from you
- Intended purpose, target users/patients and use setting.
- IVD technology description and key performance claims.
- Existing analytical/clinical datasets and study reports (if available).
- Draft labeling/IFU and risk documentation (if available).
