Performance evaluation under the IVDR is one of the most complex elements in demonstrating the safety, performance, and compliance of an IVD device.

The webinar will provide a complementary perspective by exploring two viewpoints: that of the consultant and that of the Notified Body assessor. The three pillars of Performance Evaluation — scientific validity, analytical performance, and clinical performance — will be examined, together with their connection to the intended purpose, claims, and available evidence.

Particular attention will be given to the most common issues identified during the assessment of technical documentation, evidence gaps, and the key elements that make a Performance Evaluation Report truly robust and convincing.