MDCG Guidance on Performance Studies for In Vitro Diagnostic Medical Devices
The Medical Device Coordination Group (MDCG) has issued a comprehensive guidance document, endorsed in June 2025, addressing performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746. The document, developed by representatives from all Member States and chaired by a representative of the European Commission, delineates the applicable regulatory framework and procedures. It clarifies the definitions and distinctions between analytical and clinical performance studies, stipulates when a device is deemed an in vitro diagnostic medical device (IVD) and consequently subject to the Regulation, and sets out responsibilities regarding the assignment of intended purpose and conduct of performance studies. The guidance details the requirements for application or notification to competent authorities, including specific scenarios such as studies involving surgically invasive sample-taking, companion diagnostics, and left-over samples, alongside the relevant articles of the Regulation. It further provides practical instructions on documentation, submission requirements, safety reporting, and the handling of substantial modifications. The document serves as a harmonised reference for sponsors of performance studies, clinical investigators, and manufacturers, ensuring compliance with the IVDR, while underscoring the importance of adhering to both European and national legislative requirements in the conduct of performance studies.