COMPLIANCE
or establish state of the art, particularly when comparator data are sparse or heterogeneous. Clinical diversity is essential, yet access remains uneven, requiring manufacturers to assess whether available evidence is sufficient for the intended use or whether bridging studies and clearly defined limitations are needed to support defensible performance claims.
Context matters The scenarios outlined shape diagnostic development every day, across diverse technologies and clinical setings. In rare disease diagnostics, manufacturers often rely on literature reviews, registry data, and real-world evidence to support scientific validity. However, MDCG 2022-2 highlights that such sources may not provide sufficient comparator data to demonstrate equivalence or establish the state of the art. Prospective studies may be infeasible due to small patient populations or ethical constraints, requiring adaptive designs, bridging evidence, or clearly defined limitations in performance claims. For companion diagnostics, the
link between diagnostic performance and therapeutic outcomes introduces additional complexity. Comparator data must reflect stratified patient populations, evolving treatment protocols, and the clinical context in which the test informs therapy selection. This requires close alignment between diagnostic developers, pharmaceutical partners, and clinical investigators to ensure that evidence used to support performance claims is both current and clinically relevant.
Manufacturers must assess whether
available data are current, clinically relevant, and methodologically sound
Point-of-care diagnostics introduce
further considerations. Comparator studies conducted in controlled laboratory environments may not adequately reflect real-world use, where variability in user training, environmental conditions, and workflow integration can influence performance. MDCG 2022-2 emphasises that comparator data must be aligned with the intended use seting; where this is not possible, manufacturers must transparently communicate limitations or generate bridging evidence to support claims.
In the context of blood safety, the
evolution of screening assays for HIV, hepatitis B, and hepatitis C illustrates how the state of the art shifts over time. The transition from first-generation assays to today’s highly sensitive NAT- based screening transformed transfusion safety across Europe. Under IVDR and MDCG 2022-2, updating Instructions For Use (IFU) and performance claims for such assays requires manufacturers to reflect not only analytical capability but also real-world deployment conditions, donor-population variability, and post market surveillance insights. These
considerations are essential for ensuring that performance claims remain aligned with state of the art and supported by sufficient evidence.
Practical strategies for evidence generation At BSI, advancement is about clarifying the path forward by aligning evidence strategies with evolving regulatory and clinical demands. As an EU Notified Body commited to patient safety and timely market access, we support clients in navigating this complexity with clarity, confidence, and regulatory rigor. To translate regulatory expectations
into actionable evidence, manufacturers should focus on practical, high-impact strategies that can be deployed across the product lifecycle: Real-world evidence integration. Real-world evidence, drawn from registries and electronic health records, can supplement clinical performance data. It is especially valuable for post- market follow-up and long-term safety monitoring. When methodologically sound, this strengthens relevance and trust.
September 2026
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