**Questions? [[Contact us!]]** The term 'scientific validity' refers to the confirmation of an association between an analyte (substance being measured or tested) and a clinical condition or physiological state. Annex XIII of the regulation provides further clarification and guidance to manufacturers regarding the types of evidence that can be used to meet this requirement. For well-established assays with ample published evidence, the manufacturer can rely on clinical guidelines or existing literature to demonstrate scientific validity. However, for newly developed assays, especially when there is limited published evidence available, the manufacturer is required to furnish their own evidence to establish scientific validity. This may involve conducting proof-of-concept studies or clinical performance studies. The literature or data used to support scientific validity must be summarized in a document called the Scientific Validity Report (SVR). This report should specifically address the claims made by the manufacturer in the intended purpose of the device. It's crucial to have a clear understanding of the specific disorder, condition, or risk factor the device is intended to detect, define, or differentiate. Any limitations on the conditions for which the device can be used for diagnosis must also be clearly stated. In summary, scientific validity is a critical aspect of performance evaluation for in vitro diagnostic devices, and the manufacturer must provide robust evidence to support the claims made regarding the device's intended use. This evidence is documented in the Scientific Validity Report, ensuring transparency and accountability in the evaluation process.