UK MHRA Guidance: Medical Devices That Need a Clinical Investigation and Clinical Investigations for Medical Devices

Sharan Murugan
2 hours ago
2 min read

Clinical investigations play an important role in generating clinical evidence to demonstrate the safety, performance, and clinical benefit of medical devices before they are placed on the market. Manufacturers and sponsors must determine when a clinical investigation is required and follow the appropriate notification procedures before commencing a study in Great Britain.

The guidance documents Medical Devices That Need a Clinical Investigation and Clinical Investigations for Medical Devices explain how to determine whether a clinical investigation is necessary and outline the regulatory process for notifying the MHRA about planned investigations.

Guidance: Medical Devices That Need a Clinical Investigation

This guidance explains the circumstances in which a clinical investigation is required for a medical device before it can be placed on the market in Great Britain. Clinical investigations are intended to generate sufficient clinical evidence to demonstrate that a device performs as intended and that its benefits outweigh any associated risks.

Determining Whether a Clinical Investigation Is Required

Manufacturers should assess the availability and adequacy of existing clinical evidence when determining whether a clinical investigation is necessary. Factors such as the novelty of the device, intended purpose, design characteristics, modifications to existing devices, and available clinical data should be considered during this assessment.

Where existing evidence is insufficient to demonstrate conformity with the applicable regulatory requirements, a clinical investigation may be required to obtain additional clinical data supporting the device's safety and performance.

Clinical Evaluation Considerations

The decision to conduct a clinical investigation forms part of the broader clinical evaluation process. Manufacturers should assess all relevant clinical information and determine whether available evidence adequately addresses the intended use, target population, and identified risks associated with the device.

Appropriate documentation supporting the justification for conducting, or not conducting, a clinical investigation should be maintained as part of the clinical evaluation.

Guidance: Clinical Investigations for Medical Devices

This guidance describes the process for notifying the MHRA about clinical investigations involving medical devices in Great Britain. Sponsors are responsible for ensuring that investigations are notified in accordance with the applicable regulatory requirements before commencing the study.

Notification Requirements

Sponsors should submit the required notification together with the supporting documentation necessary for regulatory assessment. The submission should provide sufficient information about the investigational device, study objectives, investigation plan, participant protection measures, and other supporting documents required to evaluate the proposed investigation.

Providing complete and accurate information helps facilitate the validation and assessment of the notification and may reduce delays during the review process.

Sponsor Responsibilities During the Investigation

Once the investigation has been notified and any applicable regulatory requirements have been met, sponsors remain responsible for investigating in accordance with the approved documentation and applicable legislation. Any substantial amendments, safety-related events, or changes affecting the investigation should be managed and reported in accordance with regulatory expectations.

At the conclusion of the investigation, sponsors should complete the required reporting activities and maintain appropriate records to demonstrate compliance with the applicable regulatory requirements.