New joint guidance supports safe and consistent validation of IVDs

The development of the new joint Validation Guidance for Medical Laboratories stems from initial discussions at LabMed’s Patient Centric Sampling Conference in February 2025. These conversations highlighted a clear need for practical guidance where validation of in vitro diagnostic devices (IVDs) is not straightforward. In reality, many laboratories use IVDs outside of manufacturers’ instructions for use (IFU), whether adapting sample types, workflows or analytical parameters. While often clinically justified, these scenarios require robust and well-documented validation. The discussions also identified inconsistency in how external verification data is used for point of care (POC) devices, with consensus that such data is acceptable where relevance to the intended population and use can be demonstrated.

In response, LabMed has worked in collaboration with the Institute of Biomedical Science (IBMS), the Medicines and Healthcare products Regulatory Agency (MHRA), and with input from the United Kingdom Accreditation Service (UKAS), to produce joint guidance supporting laboratories in delivering safe, reliable and accurate results.

The guidance focuses on ensuring IVDs are fit for purpose within ISO 15189 requirements. It reinforces laboratories’ responsibility to verify and, where necessary, validate device performance in their own clinical context, including assessing accuracy, precision, sensitivity and specificity.

Importantly, the document provides clarity on “off-label” use of IVDs. It outlines the need for formal risk assessment, consideration of ethical and legal implications, implementation of risk mitigation measures, and ongoing review.

While centred on IVDs, the principles extend to emerging technologies, including AI-driven diagnostics. By adopting a consistent, evidence-based approach to validation, laboratories can support innovation while maintaining the highest standards of patient safety.

Validation Guidelines for medical laboratories