MHRA Updates Guidance on Clinical Investigations and Introduces 2026–2027 Fee Waiver Pilot
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on how to notify clinical investigations for medical devices, with changes published on 20 April 2026.
The update includes revisions to existing processes and introduces a new phase of the clinical investigation fee waiver programme for micro and small enterprises.
Fee Waiver Pilot Extended to 2026–2027
The MHRA confirms that its fee waiver programme for clinical investigation applications will run from 20 April 2026 to 5 April 2027, or until all waivers are allocated.
10 fee waivers are available
Applicable to Class I, IIa, IIb and Class III devices (excluding active implantable devices)
Limited to UK-based micro and small enterprises
Devices must meet MHRA criteria for an “innovative device”
The MHRA states that the programme aims to support patient access to innovative devices and assess the impact of removing regulatory costs for smaller enterprises.
Notification Requirements for Clinical Investigations
The guidance reiterates that manufacturers must notify the MHRA at least 60 days before starting a clinical investigation.
It also clarifies that notification is not required where:
The device is UKCA, CE, or CE UKNI marked
The investigation is conducted within the device’s intended purpose
Additional considerations are included for:
In-house manufactured devices
Health institution exemption scenarios
Application and Assessment Process
Clinical investigation applications must be submitted via the Integrated Research Application System (IRAS).
For Great Britain:
Applications are subject to a 60-day assessment period following validation
MHRA will issue a decision of “no objection” or “objection” within this timeframe
The guidance also includes updated references to:
Validation checklists
Regulatory advice meetings
Combined IMP+Device application process
Amendments and Fees
The MHRA confirms that:
All amendments must be notified and approved before implementation
No fees apply to amendments under the current fee structure
Reporting Requirements
Manufacturers must comply with established reporting obligations, including:
Serious Adverse Event (SAE) reporting
Use of MEDDEV 2.7/3 or MDCG 2020-10 formats
Submission via the MORE portal
In addition, Quarterly Summary Reports (QSRs) must be submitted to provide updates on the overall safety profile of the investigation.
Northern Ireland Requirements
The guidance confirms that for clinical investigations involving Northern Ireland:
EU MDR (Regulation (EU) 2017/745) applies
A single MHRA application can cover both Great Britain and Northern Ireland sites
The MHRA also notes that Northern Ireland-specific guidance is under review.
Conclusion
The April 2026 update consolidates existing requirements for clinical investigations while introducing the next phase of the MHRA fee waiver pilot for small and micro enterprises.
Manufacturers planning clinical investigations in the UK should ensure alignment with the updated guidance, including notification timelines, application procedures, and reporting obligations.
Read the full document below.
