IVDR Art. 56
Performance evaluation
Obligation to demonstrate the scientific validity, analytical performance and clinical performance of the device
- Category
- Founding texts
- Market
- European Union
- Applicable classes
- Class A IVD, Class B IVD, Class C IVD, Class D IVD
- Applicable since
- May 26, 2022
In practice
Three pillars, mandatory for every class: scientific validity of the analyte, analytical performance (trueness, sensitivity, specificity, limits, interference) and clinical performance (diagnostic sensitivity and specificity, predictive values). The performance evaluation plan and report follow Annex XIII Part A and enter the technical documentation. Regulated studies fall under Articles 57 onwards.
Official sources
https://eur-lex.europa.eu/eli/reg/2017/746/oj/fraSee where this text lands in your roadmap
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