Description: Scientific Validity Reports
While the old IVD directive mainly focused on the provision of analytical performance data and limited clinical performance data, IVD Regulation 2017/746 entails more elaborate requirements in terms of safety and performance with the introduction of the concept ‘clinical evidence’. Clinical evidence consists of clinical data and performance evaluation results, pertaining to a device of sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clini
As defined in the regulation, Scientific Validity means "the association of an analyte with a clinical condition or physiological state".
To demonstrate the scientific validity, a manufacturer will need to use one or a combination of the following sources: