Performance evaluation
Scientific Validity Reports under IVDR: from literature search to defensible evidence
How to build an IVDR Scientific Validity Report that connects the analyte, clinical condition, intended purpose, literature search and total performance-evaluation evidence.
Published · Reviewed
Executive answer
Under IVDR Annex XIII, scientific validity is one of the three connected pillars of performance evaluation. A strong Scientific Validity Report does more than collect papers: it defines the analyte–condition relationship for the intended purpose, documents a reproducible search and appraisal method, resolves contradictory evidence and explains how the conclusion supports the analytical and clinical performance strategy.
Key points
- Start with the intended purpose and claim language, not with broad disease keywords.
- Keep search protocol, search results, screening decisions and appraisal records traceable.
- Separate evidence about biological association from evidence about device performance.
- Treat the report as a living performance-evaluation document and update it through PMS and PMPF.
Scientific validity is one part of one evidence chain
Annex XIII requires the performance evaluation to address scientific validity, analytical performance and clinical performance. These are not three independent documents that happen to share a cover page. The scientific-validity conclusion defines why the measured analyte is relevant; analytical performance shows how reliably the device measures it; clinical performance shows whether the result is associated with the target clinical condition or process in the intended population.
If the intended purpose changes, the scientific-validity question can change with it. A marker supported for one population, specimen or clinical role is not automatically supported for another.
Build a reproducible search, not a bibliography
The search should be planned before conclusions are written. Databases, dates, concepts, limits, duplicate handling, inclusion criteria, exclusion criteria and screening stages need enough detail for another reviewer to understand what was searched and why evidence was retained or rejected.
A broad search may be useful for discovery, but the report needs a focused claim map. The reviewer should be able to trace each final statement back to the intended purpose, a defined evidence question and the cited source.
- Define analyte, clinical condition or physiological state, population, specimen and clinical role.
- Predefine the hierarchy of source types and the treatment of reviews, guidelines and primary studies.
- Record exclusion reasons at full-text review and retain the search evidence package.
- Assess relevance, methodological quality, consistency and residual uncertainty.
What if the literature is incomplete?
A gap does not disappear because the report is longer. The correct response is to state what is not established, determine whether another legitimate source can support the relationship and decide whether new evidence is needed. The performance evaluation plan should show how the gap affects analytical studies, clinical performance work, claims and post-market follow-up.
For an established analyte, the scientific-validity argument may rely heavily on peer-reviewed literature and accepted clinical knowledge. For a novel marker, combination or clinical role, the manufacturer may need its own studies or other justified evidence. The depth should be proportionate to novelty, risk and claim specificity.
Keep the conclusion alive after certification
IVDR requires continuous performance evaluation. New literature, vigilance signals, PMPF findings, changes in clinical practice and changes to the intended purpose can all alter the scientific-validity conclusion. The report therefore needs a defined update trigger and an owner within the performance-evaluation process.
FirsTeckBio connects the search protocol, Scientific Validity Report, Performance Evaluation Plan, Clinical Performance Study Plan and Performance Evaluation Report so that updates propagate through the same controlled evidence chain.
Primary sources and review
Reviewed by the FirsTeckBio Regulatory & Clinical Team. This article is general information, not legal or regulatory advice for a specific device.