The MHRA have extended their fee waiver programme for UK micro and small enterprises developing innovative medical devices.
The updated programme will run from 20 April 2026 to 5 April 2027, following evaluation of the initial pilot.
Based on feedback, they have introduced two key changes:
- The programme now includes some Class III medical devices
- The MHRA will now review an application cover letter ahead of formal submission for a clinical investigation. This early review helps companies confirm eligibility for the scheme and the availability of a fee waiver before progressing.
To be eligible, devices must:
- Address an unmet clinical need in the UK
- Demonstrate innovation
- Have the potential to deliver wider benefits for patients and the health and social care system
The programme is open to UK‑based micro and small enterprises that meet the eligibility criteria.
Find out more about eligibility and how to apply here.
