Safety Information & Intended Use

CE Mark · Class I Medical Device · EU MDR 2017/745

Medicue AS · Org.nr. 927 533 235 Medicue UK Ltd · Co. no. 15977689 Effective: 25 March 2026

Medicue  is a health technology company specialising in patient communication and patient participation across diagnostics, treatment and follow-up care. We bring together medical expertise and technological intelligence to optimise communication between patient and clinician, enabling more efficient consultations, faster and more precise diagnostics, improved patient safety and better patient experiences. Our platform also supports clinical research, internal quality improvement work at individual clinics, and broader professional governance and follow-up at an organisational level.

1. Intended use

Medicue is intended to support structured communication, information collection and workflow preparation before, during and after healthcare interactions. It helps healthcare professionals gather relevant patient information, prepare for consultations, improve documentation quality, and support quality improvement, governance and service development activities.

2. Intended users

Healthcare professionals including optometrists, ophthalmologists, dentists, respiratory teams and other authorised users depending on deployment

Administrative or support staff authorised by the healthcare organisation to manage workflows and patient communication

Patients or service users who receive a link, form or digital interaction managed by the healthcare provider using Medicue

3. What Medicue does

Collects structured information from patients before an appointment or follow-up activity

Makes relevant information available to authorised healthcare professionals through a clinician-facing portal

Automatically highlights clinically significant responses for immediate attention by the clinician

Supports more efficient consultations, better preparation and improved communication

Supports research, quality improvement and governance activities where used lawfully

4. What Medicue does not do

Important — please read carefully

Medicue does not replace professional clinical judgement. All clinical decisions must be made by a qualified healthcare professional.

Medicue is not an emergency service and must not be used to seek urgent or emergency care. If you experience sudden vision loss, new eye pain, flashing lights or any urgent symptoms, contact your GP, call NHS 111 (UK) or attend your nearest A&E.

Medicue should not be the sole basis for diagnosis or treatment decisions without appropriate professional review.

Medicue does not guarantee that all relevant clinical information has been provided or correctly interpreted.

5. Safety information

1. Healthcare organisations should ensure that authorised users are trained in how Medicue is used locally.

2. Patient responses should be reviewed by an appropriately qualified professional within the clinical workflow.

3. Local procedures should define escalation routes for urgent findings, missed information or technical incidents.

4. User access should be role-based and removed promptly when no longer needed.

5. Medicue should be deployed and maintained in line with local information governance, clinical safety and security requirements.

6. Clinical safety governance

Clinical Safety Officer

Medicue has appointed a qualified optometrist as designated CSO, responsible for overseeing clinical risk management. Name available on request to clinical procurement teams.

Risk management

Formal process aligned with NHS Digital Standard DCB0129. Summary available on request.

Clinical validation

Clinical content validated against established guidelines and reviewed by a qualified optometrist.

7. Clinical responsibility

Clinical responsibility for assessment, diagnosis, treatment, patient communication and follow-up remains with the healthcare provider and the relevant qualified professional. Medicue is a support tool for communication and workflow, not a substitute for care delivery.

8. Incident reporting

Email: safety@medicue.com — Subject: Clinical Safety Concern
We acknowledge all reports within 2 business days.
UK: MHRA — mhra.gov.uk  ·  Norway: Legemiddelverket — legemiddelverket.no

9. Regulatory information

Classification: CE Mark, Class I Medical Device

Regulation: EU Medical Devices Regulation (MDR) 2017/745

Manufacturer: Medicue AS · Dampskipsbrygga 12A, 1607 Fredrikstad, Norway · Org.nr. 927 533 235

UK Responsible Person: Medicue UK Ltd · 47 Kings Road, Cowplain, Waterlooville, PO8 8UT · Co. no. 15977689

Safety contact: safety@medicue.com

Medicue AS · Org.nr. 927 533 235 · Dampskipsbrygga 12A, 1607 Fredrikstad, Norway
Medicue UK Ltd · Co. no. 15977689 · 47 Kings Road, Cowplain, Waterlooville, PO8 8UT, UK
www.medicue.com · safety@medicue.com · Effective: 25 March 2026

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