This MHRA guidance document provides comprehensive instructions for clinical investigators on meeting regulatory requirements for medical device investigations. The guidance outlines what must be included in submissions notifying MHRA of planned clinical investigations, including details on the approval process, conduct standards, device labeling requirements, and required documentation.

Clinical investigators and manufacturers conducting medical device research in the UK should review this guidance to ensure their investigation protocols and submissions align with MHRA expectations. The document serves as a practical reference for understanding regulatory requirements rather than establishing new obligations. No specific compliance deadlines or penalties are mentioned.