Annex XIII Section 1.2.1 of the IVDR defines scientific validity as the association of an analyte with a clinical condition or a physiological state. Evidence can come from peer-reviewed literature, consensus expert opinions and guidelines, results from proof-of-concept studies, or clinical performance studies, weighted by strength. It is one of the three pillars of IVDR performance evaluation, alongside analytical performance and clinical performance (IVDR Article 56 and Annex XIII). The scientific validity report forms part of the performance evaluation report and must be updated with new evidence through post-market performance follow-up.

Why it matters

This pillar answers a foundational question: does measuring this thing tell us anything clinically meaningful? For long-established analytes (glucose, troponin) literature alone is usually sufficient; for novel biomarkers, dedicated studies are typically required.

Common pitfalls

•Confusing scientific validity with analytical performance. Measuring an analyte accurately does not establish its association with a clinical condition.
•Assuming an established biomarker supports every proposed intended purpose. Evidence must address the relevant clinical condition or physiological state, not merely mention the analyte.
•Treating the scientific validity report as a one-time literature summary. Evidence must be critically assessed and the report updated when relevant new findings emerge.

Sources

Regulation (EU) 2017/746, Annex XIII · EUR-Lex
FDA - Medical Devices · FDA
European Commission - Medical Devices · European Commission

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Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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