Assessing Risk for the IVDR Application

The European Union’s In Vitro Diagnostic Regulation (IVDR) extends to diagnostic methods used in clinical trials, including those that inform enrollment decisions. This impacts biotechnology innovations in biomarkers used for inclusion or exclusion criteria—an approach that can reduce trial size, enhance safety, and improve therapeutic targeting.
Unlike traditional bioanalytical validation, IVDR emphasizes not only analytical performance but also clinical performance in the context of the assay’s intended purpose. A central component of compliance is the submission of a risk assessment that evaluates the assay’s impact on clinical decision-making.

This presentation introduces a practical framework for assessing IVDR-related risks, tailored specifically for bioanalytical scientists. It bridges the gap between familiar assay validation practices and the broader clinical performance expectations under IVDR, helping teams prepare for regulatory scrutiny while maintaining scientific rigor.