Instruction for Use

1. Device identification

Device name: Youwell Platform

Device type: Software as a Medical Device (SaMD)

Manufacturer: Youwell AS
C. Sundts gate 17
5004 Bergen
Norway

Regulatory status: Medical Device in accordance with Regulation (EU) 2017/745 (MDR)

Risk class: Class IIa (Rule 11)

Basic UDI-DI: ++G838YOUWELLPLATFORMUJ

Software versions covered: All released software versions sharing the same intended purpose, unless otherwise stated.

2. Intended purpose

The Youwell Platform is a reusable Software as a Medical Device (SaMD) authoring and treatment platform used by licensed clinicians and therapists to build, prescribe, deliver, and follow up structured digital behavioural and self-management programs.

The platform enables clinicians to compose programs by combining manufacturer-validated module frameworks (e.g. psychoeducational content, structured exercises, patient-reported outcome collection, diaries, reminders, dashboards, and secure messaging). Within these validated frameworks, healthcare professionals can configure program flow and content while safety-critical functionality remains within boundaries defined and validated by the manufacturer.

The Youwell Platform is intended to support clinician-guided care, blended care (combining digital and in-person interactions), and low-risk self-help use where clinically appropriate. The platform supports monitoring and follow-up by presenting patient-reported data and trends to clinicians for review.

The platform does not perform autonomous diagnosis, triage, or treatment decisions. All clinical judgement and responsibility remain with the supervising healthcare professional.

3. Intended users

Primary intended users are:

Licensed healthcare professionals (e.g. clinicians, therapists) who configure, prescribe, and supervise digital programs.
Patients who use assigned programs under supervision of a licensed healthcare professional.

4. Intended patient population

Adults (≥18 years) are the primary intended patient population.

Use in adolescents (approximately 13–17 years) is permitted only when explicitly defined in a specific program’s Instructions for Use, under clinician supervision and with appropriate consent.

The device is not intended for independent use by children under 13 years of age.

5. Intended use environment

The Youwell Platform is intended for use in:

Outpatient and ambulatory care settings (clinics, hospitals, community services)
Home and community settings under clinician supervision

The platform is accessed via supported web browsers and native mobile applications (iOS/Android) on commercially available devices with internet connectivity.

The device is not intended for offline use.

6. Contraindications

The Youwell Platform must not be used for:

Autonomous diagnosis, triage, or clinical decision-making without professional oversight
Emergency or crisis management
Independent use by children under 13 years of age
Situations requiring immediate or acute medical or psychiatric intervention

7. Warnings and precautions

The Youwell Platform does not replace professional clinical judgement. All therapeutic decisions remain the responsibility of the supervising healthcare professional.
Any indicators, flags, or visualisations presented by the platform (e.g. colour-coded indicators or trends) are advisory only and must always be interpreted by a qualified clinician.
Clinical programs must be configured and delivered within manufacturer-validated module frameworks. Safety-critical functionality must not be bypassed or altered.
The platform must only be used by patients who have sufficient language comprehension and digital literacy to understand and use the digital interface.
Secure authentication and role-based access control must be used as intended to prevent unauthorised access.

8. Limitations of use

The Youwell Platform does not embed condition-specific diagnostic algorithms.
The platform does not autonomously determine treatment pathways.
The platform does not provide emergency alerts or crisis intervention.
The platform relies on correct configuration and appropriate clinical supervision for safe and effective use.

9. Instructions for safe use (minimum requirements)

For safe and correct use of the Youwell Platform:

A licensed healthcare professional must prescribe and configure programs for patients.
Program configuration must remain within the validated module frameworks provided by the manufacturer.
Patient-reported data and indicators must be reviewed and interpreted by a qualified clinician.
Patients must only use programs explicitly assigned to them.
The platform must not be used as the sole basis for clinical decisions without professional judgement.

Failure to follow these minimum requirements may result in inappropriate or unsafe use of the device.

Detailed operational guidance, training materials, and best-practice workflows are provided separately as supplementary support materials.

10. Residual risks

Residual risks associated with the Youwell Platform primarily relate to misuse, misinterpretation of information, or insufficient clinical supervision. These risks are mitigated through:

Clinician-only configuration of programs
Clear separation between advisory information and clinical decision-making
Role-based access control and audit logging
Organisational governance and professional responsibility

11. Electronic Instructions for Use (eIFU)

This Instructions for Use is provided electronically.

The current and previous versions of the IFU are available at: http://youwell.no/ifu

The electronic version is the official version. In case of discrepancies between copies, the version available at the URL prevails.

A paper copy of the Instructions for Use can be provided upon request, free of charge, by contacting the manufacturer at the address listed in Section 1.

12. Relationship to supplementary materials

Supplementary materials such as knowledge base articles, training guides, and support documentation are provided to assist users in operating the platform efficiently.

These materials do not replace this Instructions for Use.

In case of discrepancy, this IFU prevails.

13. Version information

IFU version: v1.0
Language: English (master)
Date of issue: Februar 3, 2026

IFU Revision History

Version | Date | Description of change

v1.0 | 2026-02-03 | Initial release