The MHRA has kicked off 2026 with a rare bit of good news for early-stage medical device companies: a pilot fee waiver programme for clinical investigation applications. This is a limited opportunity for eligible startups to reduce the cost of a UK clinical investigation application.
From 4 January to 31 March 2026, the MHRA is offering ten full fee waivers for clinical investigation applications from micro and small UK enterprises developing innovative medical devices.The waivers apply to Class I, Class IIa and Class IIb devices. Once those ten slots are gone, they’re gone. This is a pilot, not a permanent free-for-all. So,if you’re a startup planning a clinical investigation this year and you qualify, this could remove a meaningful regulatory cost at a critical moment.
Who actually qualifies?
To be eligible, your device must:
- Be new or a genuinely novel modification
- Address a clinical need with no existing UK-approved solution
- Show clear innovation and scalability potential
- Be developed by a company that qualifies as a micro or small enterprise under Companies Act thresholds
- Have MHRA small enterprise status approved in advance
And yes, the MHRA will expect you to spell this out clearly in your application cover letter, with specific confirmation that you meet the criteria.
How this fits with existing SME easements
Outside the pilot, SMEs already benefit from payment easements for clinical investigation applications — typically a 50/50 split rather than paying everything upfront.
The pilot goes further by offering a 100% waiver of the application fee for a limited number of eligible investigations. It doesn’t replace the standard easements; it sits on top of them for a short period.
Where startups can trip up (and often do)
In our experience, the biggest risks aren’t technical, they’re procedural:
- Applying before SME status is formally approved
- Failing to clearly justify innovation against existing solutions
- Submitting weak or generic cover letters
- Underestimating how long it takes to align clinical, regulatory and company documentation
The MHRA won’t fix these issues for you. If anything is missing or unclear, you simply won’t get one of the ten waivers.
How we help startups make this count
For early-stage companies, the challenge is often less about the fee itself and more about navigating the process correctly. We help startups understand what the MHRA expects at the point of submission, ensure the right documentation is in place, and avoid common procedural mistakes that delay validation. This includes supporting teams to assess eligibility, structure their clinical investigation documentation, and plan submissions in a way that aligns with UK regulatory requirements.
Bottom line
The MHRA’s pilot fee waiver programme is a welcome move, pragmatic, limited, and very much aimed at serious innovators rather than box-tickers.
If you’re eligible and already planning a clinical investigation, this is an opportunity worth acting on now. If you’re still figuring out your regulatory strategy, rushing an application just to save a fee is a false economy.
As ever with medical device regulation: the money you save upfront is only useful if the application actually succeeds.
