Updates to the MHRA Clinical investigations for medical devices were published today, including a flowchart and additional guidance for when submitting clinical investigations conducted in the UK are required. Follow the links below:

• Updated webpage: https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device#full-publication-update-history
• Flowchart: https://assets.publishing.service.gov.uk/media/68a87c759e1cebdd2c96a10c/MHRA_Flow_Chart_For_Clinical_Investigations_Under_UK_MDR_Version2_August_2025.png
• Guidance: https://assets.publishing.service.gov.uk/media/68a87c553a052c9c504c8db0/GB_Flow_Chart_Accompanying_Guidance_v2.pdf