# Approving clinical investigations

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/1291b415-0e93-4118-8137-26f96505a619
Type: Guidance
Published: March 31, 2026

> This guidance document, issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA), outlines the administrative procedures and expected timelines for clinical investigation applications within Great Britain and Northern Ireland. The MHRA’s primary objective is to streamline the application review process while maintaining a high standard of patient safety. The regulatory framework emphasizes that any potential risks to participants must be minimized and clearly outweighed by the projected clinical benefits of the investigation. While the provided text does not reference a specific company, inspection dates, or individual violations, it serves as a foundational regulatory directive for all medical device manufacturers intending to conduct clinical trials in the United Kingdom. Applicants are required to align their submissions with these established protocols and should consult supplementary guidance on medical device clinical investigations to ensure full compliance. The document underscores the necessity of a rigorous justification for every proposed study, ensuring that human subject protection remains the priority during the review of investigative medical technologies. Consequently, stakeholders must adhere to the specified timetables to facilitate efficient regulatory oversight and timely market access for innovative medical solutions.

---

## Content

We aim to process applications in the shortest time possible, while ensuring that any risk to the patient and user is minimised and the investigation is justified by the potential benefit to the participants in the proposed clinical investigation. This guidance explains our processes and timetables for clinical investigations in Great Britain and Northern Ireland. You should read this alongside our guidance on clinical investigations for medical devices .

## Attachments

- [The MHRA approval process for clinical investigations](/government/publications/approving-clinical-investigations/the-mhra-approval-process-for-clinical-investigations)