Combined studies

Such studies fall under more than one EU regulation, such as the Clinical Trials Regulation and the IVDR or MDR. MDCG 2025-5 explains how to coordinate the separate applications and assessments.

Combined studies can be understood as studies that involve the simultaneous investigation of a medicinal product, an IVD and/or medical device which are subject to the requirements of the clinical trial regulation (CTR), the IVDR and/or the medical devices regulation (MDR). A combined study may also involve more than one medicinal product or more than one medical device/IVD. Examples of combined studies are a clinical trial of a medicinal product in parallel with a performance study of an IVD, or a clinical trial of a medicinal product in parallel with a clinical investigation of a medical device.

MDCG 2025-5, Introduction, footnote 1