Intended Purpose (medical device)

Status: Class I medical device under UK MDR 2002, registered with the MHRA. Conformity is self-certified by the manufacturer.

This is the canonical Intended Purpose statement for the Cogent Clinic medical device. It is the source document referenced by the Declaration of Conformity, the technical documentation file, the MHRA registration entry, the in-app labelling, and the Instructions for Use.

What the device is

Cogent Clinic is a web-based documentation tool for UK HCPC-registered practitioner psychologists. The psychologist dictates, types, or transcribes the content of a clinical session. The device produces a draft written record from that content. The psychologist reviews, edits, and signs off the draft before it enters the clinical record. The records it drafts include session notes, formulation letters, supervision summaries, and treatment-plan documentation.

Intended user

The device is for use only by qualified UK practitioner psychologists registered with the Health and Care Professions Council under one of the seven protected titles: clinical, counselling, educational, forensic, health, occupational, and sport and exercise. It is not for trainees working outside qualified supervision, for any non-HCPC-registered practitioner, or for patients or members of the public.

Intended environment

Use is through a standard web browser on a general-purpose computer, in private practice or in an organisation's clinical setting. The device is not intended for emergency, crisis, or acute care.

Intended patient population

The device does not interact with patients. The content it processes describes adult or paediatric patients receiving psychological care under the responsible psychologist. The device does not select, screen, triage, or stratify patients.

Function

The device reformats and organises content the clinician has already authored. To do that, it provides:

• In-browser de-identification of personally identifying information before any content leaves the user's machine
• Speech-to-text transcription of dictation and of consented session audio
• Handwriting-to-text extraction of clinician-uploaded PDFs and images, with extracted text entering the de-identification review before any drafting
• Draft documentation in a modality the clinician selects (CBT, EMDR, CFT, Schema, ACT, integrative, or a custom template)
• Local storage of treatment-plan and prior-draft material to give later drafts context
• Recognition of clinician-authored treatment-plan text, organised into conventional formulation sections
• Export of approved drafts to standard file formats

Limits

The device does not diagnose, screen for, or rule out any condition. It does not recommend, evaluate, or rank treatment options. It does not predict, score, or stratify risk. It does not interpret psychometric, neuropsychological, or other assessment data. It does not map symptoms or observations onto diagnostic criteria. Clinical reasoning, formulation, and opinion are the work of the responsible psychologist; the device produces none of its own. It does not alert, notify, or escalate. It does not replace clinical judgement. A draft is not part of the clinical record until the responsible psychologist has reviewed, edited, and signed it off.

The architectural boundary the device is built against: it reproduces, reformats, and organises content the psychologist has authored or supplied, and it contributes no clinical reasoning of its own.

Contraindications

The device must not be used to produce documentation that the responsible psychologist has not personally reviewed and approved. It must not be used as a sole or primary source of clinical information for any decision about a patient's care.

Out of scope of this registration

The following features may exist within the Cogent Clinic codebase or under the Cogent Clinic brand, but are not part of the registered Class I device. They are operated under separate arrangements and fall outside this conformity declaration:

• Neurodevelopmental assessment report drafting (ADHD, autism, and combined types). These features either remain in beta outside the registered scope or are migrated to a separate code path with an in-product notice.
• Cogent Witness, the expert witness report drafting tool. This is operated as a separate product under medico-legal regulatory arrangements (CPR Practice Direction 35, Academy of Experts guidance, CJC statement-of-truth requirements).

Classification

Class I medical device under the Medical Devices Regulations 2002 (as amended). Software, non-sterile, non-measuring, non-implantable, non-reusable surgical. Conformity assessment by manufacturer self-declaration; no Approved Body involvement required.

Manufacturer

Cogent Clinic Ltd Mearns Castle Golf Academy, Waterfoot Road, Glasgow, G77 5RR United Kingdom Companies House registration: SC887432 ICO registration: ZC132394

Regulatory contact for incidents and vigilance: Dr Aisha Tariq, Director, [email protected], 0141 471 3632.

As a UK-incorporated manufacturer, Cogent Clinic Ltd does not require a UK Responsible Person.