Clinical AI & Assurance
Is my software a medical device?
In short: It depends on intended purpose. If your software is intended for a medical purpose — diagnosis, monitoring, prediction, prognosis, prevention or treatment — it may be a regulated medical device (Software as a Medical Device, SaMD), and the MHRA's rules apply to placing it on the Great Britain market.
Intended purpose is the test
Regulators look at what you intend the software to do and how you describe it — not the underlying technology. A wellness or pure-reference tool is usually not a device; a tool intended to inform a clinical decision often is. Your marketing claims are part of how intended purpose is judged, which is why over-claiming is risky.
Why this matters for AI
Many AI health products fall within medical-device regulation. If yours does, you will need the right conformity assessment, technical documentation, a quality system, and ongoing post-market surveillance — alongside clinical safety and a DPIA.
Practical steps
- Write the intended purposeBe precise about what the product is — and isn't — for.
- Assess classificationDetermine whether it is a device and, if so, its class.
- Take advice earlyRegulatory and clinical input before launch, not after.
- Align your claimsMake sure public messaging matches your regulatory position.
Examples: device vs not a device
Context matters, but as illustrations: software that simply stores or displays information, or supports general wellness, is often not a medical device. Software that interprets data to flag a likely diagnosis, calculates a drug dose, or triages patients typically is. The same underlying technology can fall on either side of the line depending on the intended purpose you assign and the claims you make — which is why precise, conservative wording matters.
What being a device means in practice
If your software is a medical device for the Great Britain market, you will generally need: a defined classification, technical documentation, a quality management system, appropriate conformity assessment, the UKCA mark where applicable, registration with the MHRA, and ongoing post-market surveillance. For AI specifically, expect extra scrutiny of performance, change management and transparency. None of this should be a surprise late in development — it shapes your roadmap and budget.
The cost of getting it wrong
Two failure modes are common. The first is accidental regulation: marketing language that implies a medical purpose pulls a "wellness" product into device territory without the evidence to support it. The second is under-preparation: discovering at an NHS procurement that you need a clinical safety case, a quality system and registration you don't have. Defining intended use early — and aligning every public claim to it — avoids both.
Meds Global Health helps teams define intended use and prepare clinical evidence. See AI Validation & Clinical Safety and Medical Device Manufacturers. This is general information — formal classification and regulatory decisions rest with you and your advisers.
Answers
Frequently asked questions
What makes software a medical device?
It is the software's intended purpose that matters. If software is intended for a medical purpose — such as diagnosis, prevention, monitoring, prediction, prognosis or treatment of a condition — it may be regulated as a medical device (Software as a Medical Device, or SaMD), even without hardware.
Does AI change whether something is SaMD?
The principle is the same — intended purpose drives classification — but AI raises extra considerations around performance, change management and transparency. Many AI health products are regulated as medical devices.
Who decides the classification?
The manufacturer determines the intended purpose and, with it, whether the product is a device and its class — typically with regulatory advice and, where required, a notified body. The MHRA regulates devices placed on the Great Britain market.
What if I am not sure?
Treat it as a risk to resolve early. Define your intended purpose precisely, take regulatory advice, and avoid public claims that imply a medical purpose unless you are prepared to be regulated accordingly.
Unsure about your regulatory position?
We help define intended use and build the clinical evidence.