Description: Lab testing for clinical trials conducted in the EU often partly relies on non-CE marked IVD tests. Such tests could be companion diagnostics (CDx) in development but just as well other diagnostic tests developed in-house by the laboratory, often custom-made for the clinical trial sponsor. When pharma/biotech sponsors want to use lab-developed test (LDT) services from US laboratories for such trials, these tests can only be deployed as ‘devices for performance study’ to comply with the European IVD Regulation (IVDR). Alternatively, Europe-based health institutions may perform such tests when compliant with IVDR Article 5.5, or they may use them as devices for performance study as well. This session will discuss the regulatory consequences of each option and highlight the responsibilities of laboratories and clinical trial sponsors. The session will also include specific regulatory requirements when including devices for performance study in a clinical trial, regardless of whether these devices are being developed as a companion diagnostic or not. Finally, the session will present an overview of documentation requirements for clinical trial applications with non-CE marked diagnostic tests.
Learning Objectives:
understand the regulatory requirements for clinical trial sponsors and laboratories that conduct non-CE marked diagnostic lab tests for European clinical trials.
understand when diagnostic lab tests must fulfill the European IVDR requirements of ‘devices for performance study’, and when those of ‘in-house tests’ which are regulated by IVDR Article 5.5.
understand the requirements for documentation submission to EU Member States when using non-CE marked diagnostic tests in European clinical trials.
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