MDCG 2024-5 – Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices – April 2024

This guidance document is intended to assist sponsors of clinical investigations in the preparation of their Investigator’s Brochure by describing in more detail the type of information expected in the different sections, in order to anticipate questions from the Competent Authorities during the assessment of the clinical investigation application. 

The MDCG guidance is based on the requirements of the MDR and ISO14155:2020, as well as the experience of competent authorities.