“It’s Just a Lab Test”… Until It Isn’t. What the MHRA webinar on IVDs really means for QA leaders and sponsors

by: Paul DavidsonPublished on: 28/02/2026

When does “just a lab test” become a regulated IVD within a clinical trial? Following the recent MHRA webinar, we unpack what QA leaders and sponsors are genuinely struggling with: how routine safety labs, biomarker analyses and bespoke in-house assays fit into the current regulatory landscape. More importantly, we explore what this shift means for governance and inspection readiness. If a test result influences trial decisions, it is no longer background infrastructure. It is part of the regulated trial system. This article translates the technical guidance into practical questions you should be asking now, before an inspector does.