Originally Published IVD Technology June 2003
IVD DIRECTIVE
Demonstrating conformity|
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The central regulatory task of IVD manufacturers under the terms of the European Union's IVD Directive is to demonstrate the conformity of their products with the requirements of the directive. Such demonstrations of conformity must be supported by adequate performance evaluation data showing that the product achieves the performance stated by the manufacturer in terms of the following criteria.
- Analytical and diagnostic sensitivity.
- Analytical and diagnostic specificity.
- Accuracy (including traceability to available reference materials).
- Repeatability.
- Limits of detection.
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