Regulated medical device stance

Intended purpose (as designed)

ReadyPath’s manufacturer-stated intended purpose is administrative organisation of adult ADHD assessment referral paperwork and personal focus support while completing those admin tasks on the user’s iPhone.

It is not intended by the manufacturer to diagnose, treat, cure, monitor as a clinical instrument, predict disease risk, prescribe, triage, or prevent disease. Screening scores you enter are pack artefacts for your own filing — not a clinical instrument output.

UK MDR / MHRA

Under the UK Medical Devices Regulations 2002, software may be a medical device where the manufacturer’s labelling, instructions, and promotional materials give it a medical purpose (for example diagnosis, monitoring, treatment, or investigation of disease).

Software that only records data the user provides, helps follow an administrative procedure, and leaves clinical decisions to a healthcare professional is generally less likely to meet that definition — provided marketing and in-app claims stay consistent with admin-only intent.

ReadyPath’s designed purpose is admin logistics + evidence capture you control. This page is a product statement, not MHRA approval, UKCA marking, or a conformity assessment. Classification can change if features or claims change. See MHRA / GOV.UK guidance on software and apps as medical devices.

What would change this stance

• Claiming diagnostic accuracy, “ADHD test results”, individual disease risk scores, or treatment recommendations
• Clinical decision support that influences dose, pathway triage, or prognosis
• Monitoring disease as a medical purpose rather than admin checklist completeness
• Marketing that implies NHS clinical service or medical device status

Any such change requires fresh regulatory assessment, possible UKCA conformity work, and a new App Store regulated-device declaration.

Apple App Store Connect

Apple requires apps in Health & Fitness / Medical categories (or with frequent medical content in age ratings) to declare regulated medical device status for UK / EEA / US distribution. If intended purpose remains admin-only and claims stay consistent, publishers typically select No — but must confirm with qualified counsel and keep App Store screenshots, description, and in-app copy aligned.

Reference: Apple — regulated medical device status.

Guideline alignment

• App Review 1.4.1 — remind users to check with a doctor; no unverified diagnostic accuracy claims
• App Review 5.1.3 — no health data for advertising; no personal health information stored in iCloud by the app

Disclaimer

Nothing on this page is legal advice. UK MDR classification is fact-specific. The publisher should obtain independent UK regulatory counsel before relying on a “not a medical device” position for commercial distribution.