COMPLIANCE
Beyond the guidance: clinical and performance evidence for IVDs
The last few years have seen huge strides in the development of in vitro diagnostics, with the expected associated changes in quality assurance, guidance and regulation. But, askes Lorna Ingoldsby, what happens when the evidence required by regulatory bodies does not match up with the realities faced in the laboratory?
The Medical Device Coordination Group Document (MDCG) 2022-2 gave the industry something unique and valuable, clarifying expectations for clinical evidence under the In Vitro Diagnostic Regulation (IVDR). Titled Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices,1
it laid out detailed
principles around scientific validity, analytical performance, and clinical performance offering a structured foundation for manufacturers. However, guidance alone, regardless of how well-framed, cannot deliver the precise, context-driven evidence that IVDR demands. In the early decades of modern
diagnostics before reliable assays existed and systematic screening was established, contaminated blood products transmited HIV and hepatitis to tens of thousands of patients with haemophilia and transfusion recipients across Europe leading to thousands of deaths. This travesty exposed the urgent need for reliable diagnostic screening and became one of the most sobering reminders of how essential timely, accurate testing is to public health.2
While today’s regulatory
landscape is far more structured, the underlying lesson remains unchanged: diagnostic evidence maters because real-world consequences are profound, and IVDR formalises this by requiring that performance claims are anchored in evidence that reflects clinical relevance and real-world use.
For regulatory affairs teams, diagnostic manufacturers, and clinical laboratory directors, translating guidance to evidence reveals a complex reality.
For regulatory affairs teams, diagnostic
manufacturers, and clinical laboratory directors, translating guidance to evidence reveals a complex reality. It is often found in practice that the path to
compliance is rarely linear but shaped by data limitations, operational constraints, and day-to-day realities of clinical environments. This article examines key tensions and offers a pragmatic view for
September 2026
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