Module 19 2021

24/05/2021

IVDR Annex II, main headings

● 3.2. Manufacturing information Comment: – Requires identification of all sites, including suppliers and sub-contractors, where manufacturing activities are performed. ● 4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS Comment: – Requires demonstration of conformity with the general safety and performance requirements of the IVDR rather than the essential requirements of the IVDD

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● 5. BENFIT-RISK ANALYSIS AND RISK MANAGEMENT IVDR Annex II, main headings

● 6. PRODUCT VERIFICATION AND VALIDATION ● 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.

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