neumind
Intended Purpose Statement
What Neumind is, who it’s for, and how it sits within the UK regulatory framework for digital health products.
This page is the public-facing version of our internal Intended Purpose Statement, which underpins our DTAC v2 submission and our DCB0129 clinical-safety case.
What Neumind is
Neumind is a digital information system and wellness support tool for individuals living with cognitive impairments — typically following a brain injury, stroke, or similar neurological event.
It works as an external memory aid: scheduled reminders, simple trackers for mood and routine, and a place to record and share daily activities with the people supporting your recovery. It also helps care circles — family members, carers, and rehabilitation professionals — coordinate around the individual’s day-to-day life.
Who it’s for
- Survivors living with cognitive impairments after a brain injury, stroke, or neurological condition.
- Carers — family members and informal supporters in the survivor’s care circle.
- Rehabilitation professionals — case managers, occupational therapists, and other specialists who configure profiles, set up schedules, share resources, and review longitudinal engagement data.
What Neumind is not
To set the regulatory frame plainly:
- Neumind is not a medical device under UK MDR 2002 Article 2.
- Neumind does not diagnose any condition.
- Neumind does not treat any condition.
- Neumind does not make clinical decisions or recommend changes to a person’s care or rehabilitation.
- Neumind does not predict, modify, or replace therapy.
Clinical decisions rest with the rehabilitation professional. Neumind records, reminds, presents, and helps coordinate — it does not interpret clinical data or produce clinical output.
Independent attestation — NIHR HealthTech Research Centre
Our wellness-tool position is anchored on an independent regulatory review by the NIHR HealthTech Research Centre in Brain Injury (Innovator Report, February 2026). Two passages are particularly load-bearing.
On data handling (NIHR §6.3):
“Neumind simply presents data input by patients and family members directly to clinicians — it does not make calculations or computations that may influence a clinician’s decisions about care. It does not provide any recommendations to patients about their care or rehabilitation based on information entered into the system.”
On regulatory classification (NIHR §7):
“The application of medical device classification rules is based on the intended use description. The given description of the Neumind application clearly mentions that this is a daily activity support device, and the app does not meet the medical device definition (MDR Article 2 or UK MDR Part 1).”
NIHR also examined Neumind’s features individually:
| Feature | Medical-purpose claim? |
|---|---|
| Reminders, journaling, trackers, resources | No — supportive, compensatory aids |
| Connecting clients with clinicians and carers | No — communication and coordination |
| Recording rehabilitation activity over time | No — data capture and logging, not algorithmic interpretation |
| Moderated peer community, structured courses | No — educational and social support |
Active guardrail
NIHR’s review includes a forward-looking caveat we treat as an active design constraint:
“Attention should be paid to the device so that it does not modify or decide the therapy or alter its effectiveness below the current standard that it is offered at.”
What this means in practice: any feature we ship is checked against this line before build. Features that would modify, decide, or predict therapy — algorithmic therapy adjustment, risk scoring, diagnostic interpretation — would cross the wellness-tool boundary and trigger up-classification under UK medical-device rules. We do not build those features, and our roadmap is governed by this constraint.
We also align with the MHRA Digital Mental Health Technology guidance (3 February 2025, updated 3 July 2025) and its two-characteristic test (intended purpose + functionality). On both characteristics, Neumind sits on the wellness-tool side: our intended purpose is supportive / compensatory, and our functionality is record-keeping / reminders / coordination.
Regulatory roadmap
The NIHR Innovator Report’s Recommendation #2 calls for a defined regulatory roadmap from a MedTech regulatory expert. We have engaged Orion MedTech to deliver this work under the Chief Scientist Office grant HIPS/25/14, with the regulatory roadmap due by end of August 2026.
The roadmap will cover:
- The wellness-tool position vs. the requirements for a Class I medical device under UK MDR
- Cost-benefit analysis of pursuing UKCA marking
- A 3-year regulatory plan covering DTAC alignment + potential up-classification triggers
NHS DTAC alignment
We are aligning Neumind to the NHS Digital Technology Assessment Criteria (DTAC) v2.0 published 24 February 2026. Our DTAC v2 submission is in preparation; the public-facing summary of our section-by-section status is on our compliance page (in development). The full DTAC v2 bundle is available under NDA for procurement DD, regulatory review, or NHS pilot evaluation — request via compliance@neumind.io.
NICE Evidence Standards Framework
Neumind sits within the NICE Evidence Standards Framework (ESF) Tier C for active monitoring technologies — specifically the wellness-tool and self-management side of that tier. We expressly avoid any functionality that would constitute a Clinical Decision Support System (CDSS).
Updates to this statement
We will refresh this statement when our intended purpose, classification, or regulatory posture changes materially. The latest version is always at https://share.neumind.io/legal/intended-purpose. Material updates are also notified inside the product.
Contact
Questions about Neumind’s regulatory position, or requests for our full DTAC bundle, DPIA, or DCB0129 clinical-safety artefacts: compliance@neumind.io.