In vitro diagnostic devices do not touch patients, yet their results can determine whether patients live, suffer harm, or receive no treatment at all.

In-vitro diagnostic medical devices (IVDs) are often incorrectly perceived as inherently low risk because they test specimens rather than patients. This misconception has persisted even within international standards development, including discussions during the evolution of ISO 14971, where the inclusion of IVDs within the scope of risk-management requirements was questioned. However, decades of experience across clinical chemistry, blood screening, and companion diagnostics demonstrate that this assumption is fundamentally flawed.

IVDs directly influence clinical decision-making by informing diagnosis, treatment selection, and therapeutic monitoring. Diagnostic errors—such as false positives, false negatives, delayed results, or ambiguous outputs—can result in significant patient harm through inappropriate treatment, failure to treat, or unnecessary intervention. Although this harm is often indirect, its clinical impact may equal or exceed that of many therapeutic medical devices.

Therapeutic devices are supported by product-specific safety standards (e.g., IEC 60601-2-xx series), IVDs generally lack detailed international product safety standards. This gap complicates hazard identification, clinical risk estimation, and residual risk justification when traditional device-centric approaches are applied. Effective IVD risk management requires a diagnostic-centric framework.

This presentation examines common weaknesses in current IVD risk-management practices and presents practical methods to strengthen lifecycle safety risk assessments in alignment with ISO 14971. Approaches to more clearly document and communicate IVD clinical benefits are also discussed, enabling balanced, defensible risk–benefit conclusions that meet evolving global regulatory expectations.