Why Sylva is regulated as Software as a Medical Device (SaMD)

Trigger warning: this article contains language that many people will find offensive (including me).

Why Sylva is regulated as a medical device

UK law calls autism a "disease" and a "handicap." Those words were written into regulation in 1993 and have remained on the statute book ever since. They are not our words. They are not how we talk about autistic and ADHD people. We think they are wrong. But they are the law.

We chose to work within that legal framework anyway. This article explains why, and what that means if you are considering commissioning Sylva.

Sylva is grounded in the social model of disability. Autism and ADHD are differences, not deficits. Our purpose is to help navigate the distress and practical challenges that often accompany those differences, never to change who someone is. Because of that, people are often surprised to learn that Sylva is regulated as a medical device in Great Britain. It isn't a pacemaker, and it isn't a blood pressure monitor.

That surprise is understandable. Many digital products intentionally sidestep medical device regulations because marketing themselves as generic "wellbeing tools" is far cheaper and easier. But that shortcut comes at a real cost, and it is ultimately paid by the very people those products claim to support.

We are clear about who Sylva is for

Sylva is designed for children, adults, and families navigating autism and ADHD, whether individuals are actively diagnosed, on a waiting list, or simply suspect they are neurodivergent. It helps manage the distress and practical challenges that often accompany these profiles.

That is our intended purpose, and it has been from day one.

Both autism and ADHD are formally classified medical conditions under ICD-11: autism at 6A02 and ADHD at 6A05.

Naming them brings us into scope

Medical device regulation in Great Britain hinges on two core questions: what does your product intend to do, and who is it intended to serve?

Under Regulation 2(1) of the Medical Devices Regulations 2002, software qualifies as a medical device if it is intended for the "alleviation of" a disease, injury, or handicap. Because of how we answer both questions, Sylva falls squarely within that legal definition.

The choice every product in this space faces

This is where most teams get caught out.

Intended purpose is not determined by what a company believes internally or writes in private strategy documents. Under the regulations, it is defined strictly by the claims made across labelling, instructions for use, and promotional materials.

The Medicines and Healthcare products Regulatory Agency (MHRA) applies this literally. Its guidance on digital mental health technologies treats websites, social media, and advertising as evidence of what a product is for and who it serves.

It highlights scenarios where a brand's website frames a tool around general wellbeing, while its marketing implies it reduces the risk of depression, or primary care clinicians begin recommending it. In that situation, the MHRA gives the company two clear options:

• ·Accept regulation as a medical device, with consistent messaging and evidence to back it up.
• ·Remove every reference to a mental health condition, from every channel, everywhere, and ensure no clinician recommends it and no one uses it for a medical purpose.

Option 2 is the common route. It feels easier, and in the short term it is cheaper. But its true cost is easy to underestimate.

A product that cannot say it supports autistic or ADHD children and families cannot be designed with them, cannot be tested with them, and cannot be held accountable when it fails them.

It cannot publish outcomes for a population it is not permitted to name. And clinicians cannot recommend it, because the moment they do, the supplier steps outside its own regulatory position.

We were never going to take that route. Naming who Sylva is for is the whole point of Sylva.

The commitment behind choosing regulation

Choosing this route means accepting substantial obligations alongside rigorous external scrutiny.

Sylva is a registered UK Medical Device. We align our systems and development with key international standards:

• ·ISO 14971, 24971, and 34971: Risk management
• ·ISO 27001: Information security
• ·IEC 62304 and TIR45: Medical device software lifecycle
• ·IEC 62366-1: Usability engineering
• ·ISO 13485: Quality management

Clinical risk is managed under DCB0129, with a named, legally responsible Clinical Safety Officer. Safeguarding is overseen by a designated Safeguarding Lead.

In practice, that means:

• ·Needs-based profiles are built from scientifically validated questionnaires, not questions we invented
• ·Psychoeducation and support content is grounded in evidence-based approaches
• ·Sylva has been tested and verified against foreseeable risks, hazards, and failure modes, all recorded in a hazard log and risk registers
• ·We monitor real-world performance; problems receive root cause analysis; changes are assessed for safety before release

None of this is a promise. It is a body of documentation that commissioners can request and review.

What this means for your assurance process

When your team assesses Sylva, the evidence already exists in the format your process requires. The medical device technical file, risk management file, GDPR file, and DTAC file are not documents we will produce on request. They are the conditions under which we are permitted to operate.

Your staff can also recommend Sylva to families without creating a regulatory problem, for us or for them. That is not true of a product that has kept its intended purpose deliberately ambiguous.

Regulation is not the reason Sylva is worth commissioning. But it does mean the safety questions you are required to ask have already been answered in writing, by people who were obliged to get those answers right.

This page covers Great Britain. Northern Ireland follows EU rules under the Windsor Framework.

References

• ·The Medical Devices Regulations 2002
• ·Guidance: medical device stand-alone software including apps
• ·MHRA guidance on digital mental health technologies: device characterisation, regulatory qualification and classification
• ·ICD-11: autism (6A02) and ADHD (6A05)