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Navigating EU IVDR: A Deep Dive into Performance Evaluation for High-Risk IVDs
This episode provides a detailed breakdown of the three pillars of performance evaluation required under the EU's In Vitro Diagnostic Regulation (IVDR): scientific validity, analytical performance, and clinical performance. We focus specifically on the heightened requirements and common pitfalls for manufacturers of high-risk Class C and D devices, explaining why underestimating the clinical evidence burden is a primary cause of delays in obtaining CE marking. - What are the three essential pillars of a successful IVDR performance evaluation? - Why is a Scientific Validity Report the…
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