IVDR Clinical Performance & Performance Studies

Clinical performance demonstrates the ability of an IVD to yield results correlated with a particular clinical condition or physiological state. We design statistically sound clinical protocols and manage study regulatory compliance.

Design Your IVDR Clinical Performance Strategy

12 Key Clinical Performance Strategy Elements

Clinical performance claims definition mapped to exact target clinical condition

Target patient population, demographics and intended point-of-care / lab setting

Diagnostic sensitivity and diagnostic specificity calculation and clinical relevance

Positive/negative predictive values (PPV/NPV) and likelihood ratios aligned with prevalence

Gold-standard comparator and reference method selection strategy

Specimen selection, collection protocols and strict inclusion / exclusion criteria

Prospective clinical collection vs banked / retrospective specimen justification

Sample-size calculation, statistical power and analysis plan justification

Multi-center clinical site setup, operator variability and inter-laboratory reproducibility

Protocol for handling indeterminate, invalid, borderline and discrepant test results

Predefined statistical acceptance criteria and blinded evaluation protocols

Integration of clinical performance conclusions directly into PER, IFU and marketing claims

Performance Study Regulatory Planning (Articles 57–77)

1Determination of whether the trial falls under IVDR Article 58 / 70 performance study provisions

2Competent Authority notification and Ethics Committee (IRB/EC) submission planning

3Clinical Performance Study Plan (CPSP) and Investigator's Brochure (IB) compilation

4Adverse event and safety reporting pathway governance during the study

5Study deviations, protocol amendments and GCP / ISO 20916 data integrity compliance

6Clinical Performance Study Report (CPSR) structure and traceability to intended purpose

7Post-Market Performance Follow-up (PMPF) study design for post-clearance clinical tracking

Senior-Expert Differentiator

Capable of Supporting the Exact Clinical Claim

The question is not simply whether a clinical study was completed. The critical question is whether the study design, specimen diversity and statistical power are capable of supporting the exact clinical performance claims, intended population and clinical use environment described in the technical documentation.

Study Governance Standards

• ISO 20916: Clinical performance studies using specimens from human subjects

• MDCG 2020-16: Guidance on IVD Classification & Studies

• Ethics Committee & Competent Authority Submissions

• Biobank Specimen Data Integrity Verification

Plan Your Clinical Study

Design a defensible clinical performance protocol aligned with EU IVDR requirements.

Consult on Clinical Study

Substantiate Your IVD Diagnostic Accuracy with Robust Clinical Evidence

Our clinical specialists author ISO 20916-compliant study plans and defensible performance reports.

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