• What happens if performance evaluation data is incomplete or poorly designed?

• What standard governs clinical performance studies for IVDs?

• Do all IVD devices need the same level of performance evidence?

• When is a clinical performance study with patient samples required?

• What clinical performance parameters are assessed?

• What analytical performance parameters are typically tested?

• How does the FDA approach performance evaluation compared to IVDR?

• Is Performance Evaluation mandatory under IVDR?

• What are the three pillars of performance required under IVDR?