MHRA Updates Guidance on Clinical Investigations for Medical Devices
The Medicines and Healthcare products Regulatory Agency has updated its guidance “Clinical investigations for medical devices”, last updated on 23 July 2026.
The guidance explains how sponsors and manufacturers should notify the MHRA of their intention to carry out a clinical investigation for medical devices.
It also provides information on fees, payment, application preparation, MHRA assessment, amendments, reporting requirements and specific considerations for Northern Ireland.
Clinical Investigation Notification
The guidance states that manufacturers 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.
Where a clinical investigation is required, sponsors must inform the MHRA at least 60 days before starting the investigation.
For studies in Great Britain, sponsors should use the MHRA flow chart and accompanying guidance to determine whether an application must be submitted.
The guidance also notes that notification to the MHRA is not required for medical devices that are UKCA, CE or CE UKNI marked for the purpose under investigation.
Applications and Assessment
Applications are submitted electronically through the Integrated Research Application System.
Once the MHRA receives and validates the application, it will confirm within 5 working days whether the 60-day assessment period has started or whether there are issues to resolve.
During the assessment, MHRA experts review the safety and performance of the device, as well as the design of the proposed clinical investigation.
By the 60th day, the MHRA sends a decision letter confirming either objection or no objection to the proposed investigation.
Fees and Fee Waiver Pilot
The guidance includes information on fees and payment for clinical investigation applications.
It also describes payment easements for small and medium enterprises and a medical device clinical investigation fee waiver pilot programme for micro and small-sized enterprises.
The programme, extended into 2026–2027, began on 20 April 2026 and offers a total of ten fee waivers for eligible small and micro-sized UK enterprises conducting clinical investigations with innovative medical devices.
The waiver applies to Class I, IIa, IIb and Class III devices, but not active implantable devices.
Amendments
After receiving a letter of no objection from the MHRA, sponsors must notify the Agency of all proposed amendments before making changes.
This includes changes to:
the device under investigation;
study documentation, including the clinical investigation plan;
investigators or investigating institutions;
changes requested by an ethics committee.
The guidance states that, under the fees implemented in July 2025, no fee is payable for amendments to a clinical investigation.
Reporting Requirements
The guidance sets out reporting requirements for clinical investigations with sites in Great Britain, and for investigations with sites in both Great Britain and Northern Ireland.
All reportable events must be fully recorded and notified to the MHRA, including serious adverse events and reportable events occurring in third countries under the same clinical investigation plan.
Sponsors must also submit Quarterly Summary Reports providing updates on the overall safety profile of the investigation.
The guidance also covers reporting of study deviations, early termination, temporary halt and end-of-study reports.
Northern Ireland Requirements
The guidance includes a dedicated section for clinical investigations involving sites in Northern Ireland.
Clinical investigations requiring application to the MHRA and involving a Northern Ireland site must be submitted in line with Regulation (EU) 2017/745.
The guidance also explains requirements for amendments, substantial modifications, SAE reporting, post-market studies and sponsor or legal representative arrangements for certain studies involving Northern Ireland.
Impact on Medical Device Manufacturers
For medical device manufacturers and sponsors, the updated guidance reinforces the importance of planning clinical investigations carefully and confirming the correct regulatory route before submission.
Manufacturers and sponsors should pay particular attention to:
whether a clinical investigation application is required;
the 60-day MHRA notification timeline;
IRAS submission requirements;
application validation and assessment timelines;
payment obligations and SME easements;
fee waiver eligibility for micro and small enterprises;
amendment notification requirements;
SAE and QSR reporting obligations;
early termination and temporary halt notifications;
differences between Great Britain and Northern Ireland requirements.
For manufacturers planning clinical investigations in the UK, the guidance highlights the need for early regulatory planning, clear documentation and ongoing reporting throughout the study lifecycle.
