To validate or not to validate… that is the question

Join Debra Padgett and Mark Prescott for an overview of the newly published Validation Guidance for Medical Laboratories, developed collaboratively by IBMS, LabMed and MHRA, with input from UKAS.

The guidance provides a practical, risk-based framework to support laboratories in validating and verifying in vitro diagnostic devices (IVDs) in line with ISO 15189 requirements, including off-label use, laboratory-developed tests, Research Use Only (RUO) reagents and emerging technologies such as AI-assisted diagnostics.

This webinar will explore the key principles within the guidance, discuss how they can be applied in practice, and review real-world UK laboratory case studies that demonstrate validation approaches in challenging and evolving clinical settings.

Attendees will gain insight into regulatory, accreditation and patient safety considerations, with practical advice on implementing proportionate validation strategies within their own services.

Learning Outcomes

By the end of this webinar, participants will be able to:

• Explain the difference between verification and validation and identify when each is required under ISO 15189:2022.
• Apply a risk-based approach to validation, including the assessment of off-label use, laboratory-developed tests and emerging technologies.
• Describe how validation evidence, including data generated by other organisations, can be used to support implementation while maintaining patient safety and accreditation compliance.
• Recognise the regulatory and accreditation considerations associated with validation activities, including MHRA expectations and UKAS assessment requirements.

For further information on the guidance, see IBMS Validation Guidance for Medical Laboratories