Scientific Validity (IVDR)
The association of an analyte with a clinical condition or physiological state.
Definition
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.What this means in practice
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.Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Continuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2017/746, Annex XIIIVerifiedEUR-Lexeur-lex.europa.eu
- 2
FDA - Medical DevicesVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.