Pilot of medical device clinical investigation fee waiver program for micro and small sized enterprises
The MHRA has launched a pilot program offering clinical investigation application fee waivers to micro and small-sized UK enterprises.
The pilot program will run from the 4th of January 2026 until the 31st of March 2026.
A total of ten waivers will be available during this period for Class I, Class IIa, or Class IIb applications.
For successful waiver applicants, no clinical investigation application fee will be payable.
The pilot program is designed to support patient access to innovative devices by testing the impact of removing regulatory costs for smaller-sized firms, where those fees might act as a barrier to growth or innovation.
To be considered an innovative device, the investigational medical device must meet all the following device acceptance criteria:
(a) The product is either new or a novel modification of existing technologies.
(b) There are no solutions that fulfil the same clinical need that have regulatory approval in the UK.
(c) The device can be scaled with the end goal of benefiting the system, patients and/or care providers.
Waiver Eligibility Conditions and Application Pathway
To be considered eligible and to apply for a waiver, the following conditions must be met:
The applicant can show that the device under clinical investigation meets the three acceptance criteria for an innovative device.
The applicant is based in the UK and has obtained micro or small enterprise status from the MHRA prior to submitting their application.
The applicant submits a valid clinical investigation application from the 4th of January 2026, until the 31st of March 2026.
The applicant has included the following in the cover letter of their valid clinical investigation application:
i. Confirmation of SME status
ii. A clear statement that the applicant is applying for a waiver
iii. A comprehensive description of how the device meets the three innovative device acceptance criteria
The pilot will close on 31 March 2026, or once ten waivers have been granted.
For information on applying for SME status with the MHRA or advice/support in applying for the pilot scheme, please get in touch.