Glossary · EU in vitro diagnostics: IVDR
Performance study (IVDR)
Also known as: Clinical performance study, Interventional clinical performance study, IVD performance study
Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, a performance study is a study undertaken to establish or confirm the analytical or clinical performance of a device. Articles 57 to 77 set the requirements; studies that pose additional risks to subjects, such as interventional clinical performance studies, need authorization by the member states concerned.
- EU
- IVDR
In one sentence
A performance study under IVDR Articles 57–77 establishes or confirms an IVD’s analytical or clinical performance; some types need prior authorization.
Example
A diagnostics company runs a clinical performance study of a new sepsis biomarker assay on leftover samples from three hospital laboratories, following ISO 20916, and uses the results in its performance evaluation report.
How it applies
- Types: Analytical performance studies are usually laboratory studies. Clinical performance studies use specimens from subjects; they are interventional when the test results may influence patient management decisions.
- Authorization: Studies with surgically invasive specimen collection done only for the study, interventional clinical performance studies, studies with additional invasive procedures or risks for subjects, and companion diagnostic studies (with exceptions for leftover samples) follow the IVDR application route with ethics review.
- Leftover samples: Studies using only leftover specimens are generally not subject to that authorization route, but national rules on consent and ethics still apply.
- Good study practice: ISO 20916 is the standard for clinical performance studies using specimens from human subjects; the ethical principles of good clinical practice apply.
- Technical documentation: The study plan, the study report and, where required, the public summary feed the performance evaluation. Registration and reporting run through EUDAMED; check which modules are mandatory.
Performance study vs. clinical investigation
A performance study examines the performance of a test on specimens; the subject is often not directly affected. A clinical investigation under the MDR examines a device used in or on the subject. The IVDR route is therefore graded by the risk of specimen collection and of result-driven decisions, not by the device’s contact with the body.