What kinds of evidence satisfy the scientific validity requirement?

Acceptable evidence includes peer-reviewed literature, consensus expert opinions and clinical guidelines, results of proof-of-concept studies, and data from clinical performance studies, weighted according to the strength and relevance of the source. For well-established analytes, a systematic literature review is often sufficient, whereas novel biomarkers usually require purpose-generated study data.

Is a literature review alone always enough for a novel biomarker?

Generally no. Notified bodies expect the strength of scientific validity evidence to be proportionate to how novel or contested the analyte-disease association is, and for genuinely new biomarkers they typically expect dedicated proof-of-concept or clinical performance studies rather than literature alone. Relying solely on adjacent or indirect literature is a common deficiency finding.

How does scientific validity fit into the overall performance evaluation report?

It is one of three pillars required under Article 56 and Annex XIII, alongside analytical performance and clinical performance, and notified bodies expect each pillar documented as a separate evidence stream with its own literature search protocol and appraisal, not folded into a single narrative. Weaknesses identified in scientific validity often drive the design of the clinical performance study needed to close the gap.

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Scientific Validity (IVDR)

The association of an analyte with a clinical condition or physiological state.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026

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. 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.

What the regulation says

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), adopted on 5 April 2017 and applicable from 26 May 2022, makes scientific validity a component of performance evaluation alongside analytical performance and clinical performance. Article 56 and Annex XIII require manufacturers to establish clinical evidence supporting the device’s intended purpose. Scientific validity concerns the association between the analyte and a clinical condition or physiological state, rather than the device’s ability to measure that analyte accurately. Under Annex XIII, Section 1.2.1, manufacturers must identify relevant evidence, assess its strength and document their demonstration of scientific validity in a scientific validity report. Acceptable evidence sources include information about devices measuring the same analyte or marker, peer-reviewed scientific literature, expert consensus opinions or positions from relevant professional associations, proof-of-concept studies and clinical performance studies. The evidence must support the association relevant to the intended purpose, not merely establish that the analyte can be detected. Annex XIII, Section 1.3, places the scientific validity report within the performance evaluation report. Article 56(6) and Annex XIII, Part B, require lifecycle updating using relevant post-market surveillance and post-market performance follow-up findings.

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.

Examples

For a glucose assay intended to support diabetes assessment, a manufacturer evaluates published evidence linking blood glucose concentrations with diabetes. Analytical accuracy and clinical performance are assessed separately.
A developer proposes a novel blood biomarker for detecting early kidney injury. Limited published evidence prompts proof-of-concept and clinical performance studies to investigate the biomarker's association with that condition.
Post-market literature identifies a competing physiological explanation for elevated concentrations of a biomarker used in cancer assessment. The manufacturer reassesses the evidence and updates the scientific validity report and performance evaluation as appropriate.

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.

Frequently asked questions

Scientific validity, defined in Annex XIII Section 1.2.1 of Regulation (EU) 2017/746, asks whether the analyte itself is associated with a clinical condition or physiological state, while clinical performance asks whether the specific assay accurately detects that association in the intended population. A manufacturer can have strong scientific validity for a well-established analyte like troponin while still needing dedicated clinical performance data for a new assay format.

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EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

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IVDR Performance Evaluation

Continuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56.

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The association of an analyte with a clinical condition or physiological state.

·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.
·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.

Remember this

Watch out: Confusing scientific validity with analytical performance. Measuring an analyte accurately does not establish its association with a clinical condition.

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