IVD Performance Studies

For IVDs, clinical evidence takes the form of performance evaluation under RDC 36/2015.

Analytical performance: Accuracy/trueness, precision (repeatability & reproducibility), linearity and measuring range, LOD/LOQ, interference, cross-reactivity, stability.

Clinical performance: Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV).

For Class III and IV IVDs, a full Performance Evaluation Report (PER) is required. Point-of-care and self-test IVDs require usability testing with representative lay users and performance data under non-laboratory conditions.

---

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.