Framework
EUIVDR — Performance Evaluation
The EU IVDR 2017/746 requires manufacturers to conduct and document a performance evaluation for every IVD medical device, demonstrating conformity with the General Safety and Performance Requirements through scientific validity, analytical performance, and clinical performance evidence. The regulation specifies the performance evaluation process, data sources, and post-market performance follow-up requirements.
Overview
Background
Regulation (EU) 2017/746 introduced a comprehensive performance evaluation framework that replaced the limited evaluation requirements of the IVD Directive. The new approach requires structured evidence across three pillars — scientific validity, analytical performance, and clinical performance — reflecting the critical role IVD test results play in clinical decision-making and patient management.
Applicability
These requirements apply to manufacturers of all IVD medical devices placed on the EU market. The performance evaluation must address scientific validity, analytical performance, and clinical performance. The level of evidence required scales with device risk class. The performance evaluation must be updated throughout the device lifecycle based on post-market performance follow-up (PMPF) data.