MHRA Updates Guidance on Clinical Investigations for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance “Clinical investigations for medical devices”, last updated on 6 July 2026.
The guidance explains how sponsors should notify the MHRA of their intention to carry out a clinical investigation for medical devices. According to the MHRA, sponsors may need to carry out a clinical investigation as part of the process to obtain a UKCA, CE or CE UKNI marking for a medical device.
Sponsors planning a clinical investigation must inform the MHRA at least 60 days before starting the investigation.
Determining Whether an Application Is Required
The guidance directs sponsors to use the MHRA flow chart and accompanying guidance to determine whether a clinical investigation application is required.
For studies in Great Britain, the MHRA notes that updated versions of these documents were published in August 2025and should be reviewed by applicants.
The guidance also states that a notification to the MHRA is not required for medical devices that are UKCA, CE or CE UKNI marked for the purpose under investigation.
For studies involving Northern Ireland, sponsors should use the specific flow chart and accompanying guidance in the Northern Ireland section of the MHRA guidance.
Fees and Fee Waiver Pilot
The MHRA guidance includes information on fees, payment procedures and payment easements for small and medium enterprises.
The document also describes a pilot medical device clinical investigation fee waiver programme for micro and small sized enterprises. The programme is being extended into 2026–2027, beginning on 20 April 2026.
A total of ten clinical investigation application fee waivers will be available for eligible small and micro sized UK enterprises conducting clinical investigations with innovative medical devices.
The guidance states that the programme will run until 5 April 2027 or until all fee waivers have been granted.
Applications and Assessment
Applications for clinical investigations are submitted electronically through the Integrated Research Application System (IRAS).
For clinical investigations conducted in Great Britain, once the MHRA has received and validated the documents, the agency will contact the applicant within 5 working days to confirm whether the 60-day assessment period has started or whether there are any issues.
During the assessment, the MHRA reviews the safety and performance of the device and the design of the proposed clinical investigation. The MHRA will issue a decision letter by day 60, stating whether there is an objection or no objection to the investigation.
Amendments and Reporting Requirements
Once a sponsor has received a letter of no objection, the MHRA must be notified of proposed amendments before changes are implemented.
The guidance also sets out reporting requirements, including:
serious adverse event reporting;
quarterly summary reports;
study deviations;
early termination or temporary halt of a clinical investigation;
end of study reports.
SAE reports and quarterly summary reports should be submitted through the MORE portal.
Northern Ireland Requirements
The guidance explains that clinical investigations involving sites in Northern Ireland must be submitted to the MHRA in line with the requirements of Regulation (EU) 2017/745.
A single application can cover sites in both Great Britain and Northern Ireland for the same clinical investigation.
The guidance also includes specific requirements for Northern Ireland regarding assessment, amendments, SAE reporting and post-market studies.
Impact on Medical Device Manufacturers
For medical device manufacturers and sponsors planning clinical investigations in the UK, the updated MHRA guidance reinforces the importance of early regulatory planning and correct submission pathways.
Manufacturers should pay particular attention to:
determining whether a clinical investigation application is required;
the 60-day MHRA notification period;
use of IRAS for applications;
validation checklist requirements;
payment and fee waiver eligibility;
amendment procedures;
SAE and quarterly summary reporting through the MORE portal;
differences between Great Britain and Northern Ireland requirements.
For manufacturers developing innovative devices, the extension of the fee waiver pilot may be particularly relevant, especially for eligible micro and small sized UK enterprises seeking to reduce regulatory costs associated with clinical investigation applications.
