Description: Clinical evidence is central to achieving compliance with the IVDR. Introduced with the IVDR in May 2017, clinical evidence requirements have presented ongoing challenges, particularly in meeting the performance evaluation criteria. These challenges have been a major cause of deficiencies identified by Notified Bodies during technical documentation assessments.
Understanding how the intended purpose drives the three pillars of clinical evidence—scientific validity, analytical performance, and clinical performance—along with the continuous benefit/risk ratio assessment, remains complex. Notably, clinical performance requirements have emerged as the primary area of concern for Notified Bodies.
In this session, we will explore effective strategies for IVDR clinical evidence compliance. Participants will gain a comprehensive understanding of the clinical evidence framework under the IVDR and learn how to meet these requirements efficiently across various device portfolios. Topics will include strategies to optimize compliance, such as leveraging clinical performance data for legacy IVD devices and integrating the continuous performance evaluation process into organizational quality management systems.
