MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices – March 2024

This guide is intended to help sponsors draw up their clinical investigation plan, a document whose content is crucial to the conduct of the clinical investigation. 

This document is based on section 3 of chapter II of annex XV of the MD Regulation as a starting point and follows the numbering of the MD Regulation, in order to facilitate cross-referencing with the legal requirements. It describes in more detail the type of information expected in the different sections of the clinical investigation plan, in order to anticipate questions from the competent authorities when assessing the clinical investigation application. 

The requirements of the MD Regulation and ISO14155:2020, as well as the experience of the competent authorities, have been used to draw up this guidance document. 

It is not, however, a model for drafting a clinical investigation plan. It is not mandatory to present the information in a clinical investigation plan in the same order as it is mentioned in the MDR or in this guidance document.