IVD Studies – Analytical & Clinical Performance

CLINICAL PERFORMANCE FAQs

• What is IVD clinical performance?

IVD clinical performance refers to the ability of an IVD device to accurately diagnose or predict the presence or absence of a specific medical condition or disease in patients. IVD clinical trials, with prospective or retrospective study designs are typically required to establish clinical performance.

This is a critical component of the regulatory approval process for IVD devices, as it demonstrates the device’s ability to produce reliable and accurate results, which is essential for ensuring patient safety and effective clinical decision-making.

• Why is IVD clinical performance important?

IVD clinical performance is important because it demonstrates the device’s ability to produce reliable and accurate results, which is essential for ensuring patient safety and effective clinical decision-making.

Accurate and reliable diagnosis is critical for guiding patient treatment and management, and IVD devices play a key role in this process.

• What factors are evaluated in IVD clinical performance studies?

IVD studies evaluate several factors, including diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, and others.

These studies typically involve testing the device in a large and diverse patient population, including those with and without the target medical condition or disease.

• What are the main gaps identified in IVD Clinical Performance Studies?

The main gap identified in IVD studies is the application of sources to demonstrate clinical performance. There is often a lack of clarity and consistency in the application of sources of clinical performance data, which can lead to confusion and inconsistencies in regulatory submissions.

Clinical performance data should be presented in a manner that is consistent with regulatory requirements, such as Annex XIII 2.3 of the IVDR. Clinical Performance studies are typically required unless the manufacturer can comfortably rely on other sources, including peer reviewed literature for example.

• Lack of consideration for professional, near-patient and self-test requirements: there is a lack of data and suitably designed studies that support clinical performance in different use settings, including professional, point of care and home-use settings.
• Insufficient clinical performance data for legacy devices: there is often insufficient clinical performance data available for legacy IVD devices, which can lead to concerns about the reliability and accuracy of the diagnostic testing.
• Insufficient sample size or patient population: some IVD clinical performance studies have insufficient sample size or patient population, which can result in inconclusive or unreliable study results.
• Incomplete data collection or analysis: notified Bodies and FDA often find identified instances where clinical performance study data collection or analysis is incomplete, which can lead to unreliable or inconclusive study results.