Strategies to Improve Scientific Validity Report under EU IVDR 2017/746

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Strategies to Improve Scientific Validity Report under EU IVDR 2017/746

A Scientific Validity Report (SVR) is a part of the Performance Evaluation Report (PER) under the European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 that documents the scientific validation of the IVDs. The SVR supports the device's conformity assessment and for the same one must consider any relevant published literature and standards. It is usually accompanied by a summary of the results of the assessment.