A newly published joint resource from IBMS, LabMed and MHRA, with input from UKAS, supports laboratories in validating and verifying IVDs in line with ISO 15189.
Medical laboratories work with diagnostic devices and methods that need local verification or full validation to ensure they are fit for purpose in their own environment. Validation Guidance for Medical Laboratories – which has been jointly produced by the Institute of Biomedical Science (IBMS), the Association for Laboratory Medicine (LabMed), and the Medicines and Healthcare products Regulatory Agency (MHRA) - provides a principles-based framework for doing so, aligned with ISO 15189 requirements for quality, competence and patient safety.
The guidance covers verification of manufacturer performance claims, validation of modified or off-label use, integration into laboratory-developed testing, and the use of Research Use Only (RUO) reagents. It also applies the same risk-based validation principles to emerging technologies, including AI-driven laboratory systems and digital pathology platforms.
A practical stepwise workflow and quick-reference requirements matrix are included to support laboratories in planning, executing and documenting validation activities proportionate to clinical risk.
Four UK laboratory case studies illustrate the guidance in practice: self-taken swabs for CT/GC testing, a blood spot 17-hydroxyprogesterone assay for paediatric CAH monitoring, upper arm capillary blood collection for routine chemistry in patients with learning disabilities, and validation of an RUO next-generation sequencing gene panel for solid tumours.
Download the guidance document here: Validation Guidance for Medical Laboratories.