Compliance with IVDR requires a Performance Evaluation, including the assessment and analysis of data to establish or verify the scientific validity, the analytical performance, and, where applicable, the clinical performance of an IVD. IPN’s support in this area includes: • Development of the Performance Evaluation Plan (PEP) • support in demonstrating the scientific validity and the analytical and clinical performance • Elaboration of the Performance Evaluation Report (PER) • Gap Analysis on scientific validity, analytical and clinical performance data This service provides a structured and regulation-compliant approach to performance evaluation, facilitating both regulatory approval and the ongoing lifecycle management of IVD devices.