UK MHRA Guidance: Clinical Investigations in Great Britain, Approving Clinical Investigations, and Compiling a Submission

Sharan Murugan
1 hour ago
2 min read

Clinical investigations are an essential part of demonstrating the safety and performance of medical devices before they are placed on the market. Organizations conducting investigations in Great Britain must ensure that studies are appropriately planned, approved, and supported with complete regulatory documentation.

The guidance documents Clinical Investigations in Great Britain, Approving Clinical Investigations, and Compiling a Submission outline the regulatory framework, approval process, and submission requirements for conducting compliant clinical investigations in Great Britain.

Guidance: Clinical Investigations in Great Britain

This guidance outlines the regulatory requirements for conducting clinical investigations involving medical devices in Great Britain. Clinical investigations are performed to generate evidence on the safety, performance, and clinical benefits of a device while ensuring the rights, safety, and well-being of participants remain protected throughout the study.

When Clinical Investigations Are Required

Clinical investigations may be necessary to establish clinical evidence for new or modified medical devices, support conformity assessment requirements, or evaluate device performance where existing clinical data are insufficient. Manufacturers should determine the need for an investigation based on the intended purpose, device classification, and available evidence.

Responsibilities During Clinical Investigations

Manufacturers and sponsors are responsible for ensuring investigations are designed, conducted, monitored, and reported in accordance with applicable regulatory requirements. Investigations should follow an appropriate clinical investigation plan, maintain participant protection, and document any significant safety information throughout the study.

Guidance: Approving Clinical Investigations

Before a clinical investigation begins, sponsors must obtain the necessary regulatory approvals where required. The approval process ensures that proposed investigations comply with applicable legal requirements and that participant safety and study integrity are appropriately considered before enrolment starts.

Regulatory Assessment

Applications are reviewed to determine whether the proposed investigation provides sufficient information regarding the investigational device, study objectives, risk management, participant protection, and overall study design. Regulatory assessment helps confirm that the investigation can be conducted safely and in accordance with applicable legislation.

Following Approval

Once approval requirements have been met, sponsors are responsible for investigating according to the approved documentation. Significant changes, safety reporting obligations, and completion of the investigation should be managed in line with regulatory expectations throughout the study lifecycle.

Guidance: Compiling a Submission

This guidance describes the information and documentation that should accompany a clinical investigation submission. Providing a complete and well-structured application supports efficient regulatory review and helps minimise delays during the assessment process.

Submission Documentation

Applications should include the required administrative information together with documentation describing the investigational device, clinical investigation plan, investigator information, participant documentation, risk management information, and other supporting evidence necessary for regulatory assessment.

Preparing a Complete Submission

Sponsors should ensure that all required documents are complete, accurate, and consistent before submission. Well-prepared documentation facilitates the validation process and enables regulators to assess whether the proposed investigation meets applicable regulatory requirements.