Many healthtech founders set out to solve a problem, and building a product is part of delivering that solution. At some point someone will ask ‘Is this a medical device?’ This is an important consideration and one you should plan for rather than it surfacing during a procurement conversation with an NHS trust.
What makes software a medical device?
The MHRA defines Software as a Medical Device (SaMD) as software intended to be used for a medical purpose without being part of a hardware device. If your product supports clinical decision-making, it may be in scope. If it is purely administrative, less likely, though the line gets complicated when AI is involved.
The MHRA's guidance on AI and medical products reflects how rapidly this territory is evolving. The AI Airlock programme, launched in 2026 with £3.6 million in funding, offers a structured regulatory sandbox for AI-enabled health products. Companies that have done their safety groundwork will be better placed to move through it.
Where does DCB0129 come in?
DCB0129 is the UK clinical safety standard for manufacturers of healthtech. If your product will be deployed in the NHS and affects patient care (in any way), you must comply with it, even if you are a medical device.
That means appointing a suitably qualified CSO, undertaking a formal risk identification, assessment and management process, documenting it via a clinical safety case report and sharing it with organisations who want to buy your product.
NHS England explains that organisations implementing any digital health technology, regardless of medical device status, must request this documentation during procurement.
Research co-authored byCuristica’s Dr Youssof Oskrochi and Dr Keith Grimes found that around 70% of nearly 15,000 NHS deployments had no documented safety case (Oskrochi et al, JMIR 2025). A clear one sets you apart.
When should you start?
Before a procurement team asks. Clinical safety conversations are easier and cheaper when they can shape product decisions rather than retrofit documentation onto a product that already exists.
Use our free Clinical Safety Case Quality Tool to benchmark where you are now. Once you've got that picture, Curistica's DCB0129 service will provide you with actionable gap analysis, hazard log development, and fractional CSO support - get in touch to book an intro call.
