Do all IVDs need a prospective clinical performance study?

Not necessarily. Retrospective studies using banked or leftover samples are acceptable where justified by the intended use and population, but higher-risk Class C and D devices, particularly companion diagnostics and screening tests, more often require prospective performance studies. The justification for the chosen study design must be documented in the performance evaluation plan.

How does clinical performance evidence differ for a companion diagnostic?

For a companion diagnostic, clinical performance evidence must demonstrate the assay correctly identifies patients likely to benefit from or be at risk from the corresponding medicinal product, which usually requires alignment with the pivotal drug trial population and, per Article 48(5), a notified body consultation with the EMA or a national competent authority. Generic clinical performance data unlinked to the drug's approved population is generally insufficient.

What is a common mistake when using literature to support clinical performance?

A common mistake is citing publications that used a different assay, population, or disease prevalence than the device under evaluation and treating the results as directly transferable. Notified bodies expect an equivalence justification when literature from another device is used to support clinical performance claims.

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Clinical Performance (IVDR)

The ability of an IVD to yield results correlated with a clinical condition in the target population and intended user.

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

Definition

Annex XIII Section 1.2.3 of the IVDR describes clinical performance in terms of diagnostic sensitivity and specificity, positive and negative predictive value, likelihood ratios, and expected values in normal and affected populations. Evidence can come from clinical performance studies, peer-reviewed literature, or routine diagnostic testing experience.

What the regulation says

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), adopted on 5 April 2017 and generally applicable from 26 May 2022, sets out clinical performance requirements in Annex XIII, Section 1.2.3. Manufacturers must demonstrate clinical performance against the parameters in Annex I, Section 9.1(b), unless an omission is justified as not applicable. These include diagnostic sensitivity and specificity, positive and negative predictive values, likelihood ratios, and expected values in normal and affected populations. For MedTech manufacturers, the assessment must relate to the device’s intended purpose and population, rather than establish analytical accuracy alone. Annex XIII, Section 1.2.3, permits evidence from clinical performance studies, scientific peer-reviewed literature, and published experience gained through routine diagnostic testing. Clinical performance studies are required unless sufficient justification supports reliance on other sources of clinical performance data. The manufacturer must demonstrate and document clinical performance in a clinical performance report. Under Article 56 and Annex XIII, this evidence forms part of the broader performance evaluation alongside scientific validity and analytical performance. The evaluation must be updated throughout the device’s lifecycle, including through post-market performance follow-up where applicable.

What this means in practice

Clinical performance often requires prospective studies for higher-risk classes (C and D), particularly companion diagnostics and screening tests. Retrospective banked-sample studies are acceptable where justified by the intended use and population.

Examples

A screening assay is evaluated prospectively in people eligible for the intended screening programme. Investigators compare results with an appropriate reference standard to estimate diagnostic sensitivity, specificity, and predictive values.
A companion diagnostic is assessed using banked tumour samples linked to treatment outcomes. The manufacturer justifies that sample handling, patient selection, and available clinical data adequately represent the intended use.
An assay intended to help diagnose an infection is supported by peer-reviewed studies and published routine diagnostic testing experience. The manufacturer assesses whether the populations, testing settings, and reported performance measures support its specific claims and addresses remaining evidence gaps.

Common pitfalls

•Treating analytical performance as proof of clinical performance. Accurately measuring an analyte does not alone establish how well results identify or correlate with a clinical condition.
•Assuming predictive values transfer unchanged between populations. Differences in disease prevalence and patient selection can change the clinical meaning of a positive or negative result.
•Assuming every class C or D device requires a prospective study, or that banked samples are automatically sufficient. Study design and evidence must be justified against the intended purpose, population, and relevant risks.

Frequently asked questions

Annex XIII Section 1.2.3 describes clinical performance in terms of diagnostic sensitivity and specificity, positive and negative predictive value, likelihood ratios, and expected values in normal and affected populations. These measures must be established in the device's intended population and by its intended user, not extrapolated from a different clinical setting.

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Regulatory

EU In Vitro Diagnostic Regulation(IVDR)

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

Regulatory

IVDR Performance Evaluation

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

Market Segments

Companion Diagnostic(CDx)

IVD that identifies patients who will benefit from a specific drug.

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FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

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513(g) Request for Information(513(g))

Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

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510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.

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The ability of an IVD to yield results correlated with a clinical condition in the target population and intended user.

·Clinical performance often requires prospective studies for higher-risk classes (C and D), particularly companion diagnostics and screening tests.
·Retrospective banked-sample studies are acceptable where justified by the intended use and population.
·Evidence can come from clinical performance studies, peer-reviewed literature, or routine diagnostic testing experience.

Remember this

Watch out: Treating analytical performance as proof of clinical performance. Accurately measuring an analyte does not alone establish how well results identify or correlate with a clinical condition.

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