Module 19: Regulation of In Vitro Diagnostic Medical Devices

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6.1. Information on analytical performance of the device 6.1.2.1. Accuracy of measurement 6.1.2.2. Analytical sensitivity 6.1.2.3. Analytical specificity 6.1.2.4. Metrological traceability of calibrator and control material values 6.1.2.5. Measuring range of the assay 6.1.2.6. Definition of assay cut-off 6.1.3. The analytical performance report referred to in Annex XIII.

IVDR Annex II, Product verification and validation

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IVDR Annex II, main headings

● 6.2. Information on clinical performance and clinical evidence. Performance Evaluation Report – Performance evaluation plan – Scientific validity report

– Analytical performance report – Clinical performance report

– Summary of safety and performance (and product verification by EU reference laboratories and common specifications (CS) if applicable)

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