Instructions for Use (IFU)

Symbol	Meaning
	CE-marked. Notified Body: TÜV SÜD Danmark ApS (NB 2443). EU Quality Management System Certificate No. G11DK 136913 0002 Rev. 00, valid from 2026-10-15 to 2031-10-14.
	Manufacturer: Youwell AS, C. Sundts gate 17, 5004 Bergen, Norway
	Medical Device
	Electronic Instructions for Use available at https://youwell.no/ifu
	UDI: Basic UDI-DI ++G838YOUWELLPLATFORMUJ

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.

Medical indications

The Youwell Platform does not carry a diagnosis- or condition-specific medical indication, and Youwell AS does not claim clinical benefit or effectiveness for any specific medical condition. The platform is a configurable Software as a Medical Device (SaMD) intended to support licensed healthcare professionals in authoring, prescribing, delivering, and following up structured digital behavioural and self-management programmes, consistent with the Intended Purpose Statement. Selection of clinical content, target population, and programme objectives for any individual programme delivered on the platform is the clinical responsibility of the delivering healthcare provider organisation. The platform does not embed condition-specific diagnostic algorithms and does not determine treatment pathways; all clinical judgement regarding diagnosis, treatment selection, and clinical management remains the responsibility of the supervising licensed healthcare professional.

Clinical benefit

The Youwell Platform has no direct clinical benefit of its own, and Youwell AS makes no clinical-benefit claim. Any benefit to the patient is indirect: it arises when a healthcare professional uses the platform to deliver and follow up a programme that the healthcare provider organisation has selected for the patient. The clinical effect of that programme depends on the programme content and on the healthcare provider, not on the platform.
The platform's contribution is described by four device claims (Claims Matrix v1.1, C1–C4), which concern the platform's performance, usability and safety:

• Structured programme delivery (C1): clinicians can author, prescribe, deliver and follow up structured digital behavioural and self-management programmes within manufacturer-validated module frameworks.
• Usability and acceptability (C2): the platform is usable and acceptable for both clinicians and patients.
• Favourable safety profile (C3): the platform is a non-invasive software device whose risks are controlled through the manufacturer's risk management; risk-based indicators for clinician review, secure communication and clinician oversight of programme content support its safe use.
• Engagement and structured follow-up support (C4): reminders, notifications, scheduling and secure messaging support patient engagement and structured follow-up within clinician-guided programmes.

Youwell AS does not claim symptom improvement or any other clinical outcome for any specific medical condition. Clinical outcomes for any individual patient remain the responsibility of the delivering healthcare provider and the clinical content of the assigned programme.

Performance characteristics

The Youwell Platform performs the following functions in support of its intended purpose:

• Structured programme delivery: The platform delivers clinician-authored treatment programmes to patients through a configurable sequence of modules, content pages, and interactive exercises within manufacturer-validated module frameworks.
• Patient-reported outcome capture: The platform captures structured patient responses to questionnaires, diaries, and health registrations and presents aggregated data and trends to the supervising clinician.
• Risk indicator display: The platform calculates and displays risk-based indicators (colour-coded flags) when patient-reported data meet a defined flagging rule. For validated questionnaires, flagging follows the instrument's published cut-off values or, where no cut-off is published, a rule defined by the manufacturer; for other health registrations, the threshold is configured by the responsible clinician. Indicators are advisory only.
• Secure clinician–patient communication: The platform supports asynchronous messaging and scheduled video consultations between clinicians and patients.

The platform does not perform diagnostic calculations, autonomous clinical assessments, or physiological measurements. All performance is contingent on correct configuration by a licensed 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

• (ISO 15223-1: 5.4.4) – The Youwell Platform does not replace professional clinical judgement. All therapeutic decisions remain the responsibility of the supervising healthcare professional.
• (ISO 15223-1: 5.4.4) – 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.
• (ISO 15223-1: 5.4.4) – Clinical programs must be configured and delivered within manufacturer-validated module frameworks. Safety-critical functionality must not be bypassed or altered.
• (ISO 15223-1: 5.4.4) – The platform must only be used by patients who have sufficient language comprehension and digital literacy to understand and use the digital interface.
• (ISO 15223-1: 5.4.4) – 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.
• Wearable sensor data displayed through third-party device integrations (where enabled) reflects consumer-grade measurements and has not been clinically validated as a medical measurement device. Such data is supplementary and advisory only, and must not replace clinically validated assessments or direct clinical observation.

When to consult a healthcare professional

Patients should consult their supervising healthcare professional if: symptoms worsen or new symptoms arise during the course of a programme; they experience distress in connection with programme content or exercises; they are uncertain whether the programme is suitable for their current clinical condition; or they have not received a response from their clinician within an expected timeframe. The platform is not a substitute for direct clinical contact and must not be used in situations requiring immediate medical attention.

9. Instructions for safe use (minimum requirements)

For safe and correct use of the Youwell Platform, the following minimum requirements must be met:

Clinical and organisational requirements

• A licensed healthcare professional must prescribe and configure all programs for patients.
• Program configuration must remain within the validated module frameworks provided by the manufacturer.
• Patient-reported data and risk indicators must be reviewed and interpreted by a qualified clinician.
• Patients must only use programs explicitly assigned to them by a clinician.
• The platform must not be used as the sole basis for clinical decisions without professional judgement.
• Secure authentication and role-based access control must be used as intended to prevent unauthorised access.
• Users must have sufficient language comprehension and digital literacy to understand and use the digital interface.
• Training in the use of the platform is recommended prior to first clinical use. Training materials and operational guidance are available at https://support.youwell.no

Minimum hardware requirements

• Device: PC, Mac, tablet, or smartphone (commercially available)
• Screen resolution: minimum 1280 × 720 pixels (clinician portal); minimum 360 × 640 pixels (patient application)
• Internet connection: stable broadband or mobile data connection (minimum 5 Mbps recommended)

Minimum software requirements — Clinician portal (web)

• Any modern, up-to-date web browser with JavaScript enabled is supported, including current versions of Google Chrome, Mozilla Firefox, Microsoft Edge, and Apple Safari.
• The platform is designed to be compatible with the most widely used browser versions in current circulation.

Minimum software requirements — Patient application (mobile)

• The patient application is available for iOS and Android on commercially available smartphones and tablets.
• The application is designed to support a broad range of device generations and operating system versions. Specific compatibility information is available at http://youwell.no/ifu
• iOS: version 15 or later (iPhone and iPad)
• Android: version 10 or later

IT security requirements

• Access to the platform must be protected by secure authentication
• Devices used to access the platform should be protected with a PIN, password, or biometric lock.
• The platform must not be used on unsecured or public Wi-Fi networks without VPN or equivalent protection.
• Session timeout and automatic logout features must not be disabled.

Failure to meet these minimum requirements may result in reduced functionality, data integrity issues, or inappropriate or unsafe use of the device.
Detailed operational guidance, training materials, and best-practice workflows are provided separately as supplementary support materials available at https://support.youwell.no/support/solutions

10. Technical description

The Youwell Platform is a cloud-hosted Software as a Medical Device consisting of three integrated components: a clinician portal (web application), a patient application (web and native iOS/Android), and a shared backend services layer. The backend is hosted on Microsoft Azure (Norway East/West) and provides authentication, data storage, scheduling, notifications, and API services. All data is transmitted using TLS 1.2 or higher and stored encrypted at rest. The platform operates as a multi-tenant system with strict tenant isolation. Users access the platform via supported web browsers or the native mobile application. No local installation is required beyond the mobile application download from Apple App Store or Google Play Store.

11. Residual risks

Residual risks associated with the Youwell Platform have been identified and assessed through the manufacturer's risk management process in accordance with ISO 14971. The following residual risks remain after implementation of risk control measures and are considered acceptable. Users should be aware of the following:

Clinical supervision and decision-making

The platform provides decision support only and must not be used as the sole basis for clinical decisions. All therapeutic decisions remain the responsibility of the supervising healthcare professional.
Risk indicators, colour-coded flags, and data visualisations are advisory only and must always be interpreted by a qualified clinician. Where risk indicator thresholds are configured by the responsible clinician (i.e. other than the flagging rules of validated questionnaires), they must be reviewed regularly to ensure clinical appropriateness. Incorrect threshold configuration may result in missed alerts or false alerts.
Patient-reported data, questionnaire results, and progress reports must be reviewed and interpreted by a clinician. Self-reported data may be incomplete or inaccurate.
Reminders and notifications delivered by the platform are supportive tools only and are not prescriptive instructions. Clinical responsibility for follow-up remains with the supervising healthcare professional.
Some users may find aspects of the user interface unclear, particularly for infrequently used functions; in-app guidance and tooltips are provided, and further support is available at https://support.youwell.no. Notifications and reminders are batched (e.g. as periodic summaries) rather than delivered as continuous real-time alerts, to reduce the risk of alert fatigue; clinicians should nonetheless review the clinician portal on a regular schedule rather than relying solely on notification receipt, so that a high volume of routine notifications does not result in a critical flag being overlooked.

Use by specific patient groups

Use by adolescents (approximately 13–17 years) is only permitted where explicitly defined in a specific program's Instructions for Use, under clinician supervision and with appropriate consent.
Patients with cognitive impairment, severe psychiatric disorders, or insufficient digital literacy may require additional support from a caregiver or clinician. The platform must not be used independently by patients whose clinical condition is not suitable for remote, asynchronous digital interventions.
The platform is not intended for patients requiring acute psychiatric or medical intervention.

Content and program configuration

Clinical programs must be configured and delivered within manufacturer-validated module frameworks. New programs or modules must not be introduced without proper clinical review and validation by the responsible healthcare organisation.
Therapeutic content must be personalised and reviewed by the responsible clinician before assignment to a patient. Content that has not been reviewed for the individual patient's clinical condition may be triggering or distressing.
Content version and date are visible within the platform. Clinicians should ensure that program content reflects current clinical guidelines.
Where integrations with external systems (e.g. electronic health record systems) are used, data consistency must be verified by the responsible clinician before acting on integrated data.

System availability and data integrity

The platform may be temporarily unavailable due to scheduled maintenance or unplanned outages. The platform must not be relied upon for time-critical clinical monitoring without alternative follow-up procedures in place. Platform unavailability may in some cases result from an infrastructure-level security event (e.g. a denial-of-service event) rather than routine maintenance; such incidents are managed under Youwell's cybersecurity and incident response procedures, and the same guidance above applies. Software updates and releases are subject to verification and validation prior to deployment; in rare cases a release may result in configuration settings being reset or requiring re-confirmation. Clinicians should verify programme and risk-indicator configuration after being notified of a software update, and should contact support if configuration does not match expected settings.
If the application crashes or becomes unresponsive, restart and re-login. Patient data is automatically saved. If data appears inconsistent or incomplete after a restart, contact the manufacturer's support before acting on the information.
If historical patient data or programme records appear to be missing or unavailable that cannot be explained by a temporary outage, contact the manufacturer's support before assuming that the data has been permanently lost. Do not make treatment decisions based on the absence of expected data without first confirming with support whether the data can be recovered.
Data is retained in accordance with the manufacturer's data retention policy. Users are responsible for ensuring compliance with applicable local data protection legislation.
Where wearable device data is displayed within the platform, this data is sourced from consumer wearable devices via third-party middleware and is advisory only. Consumer wearable sensors may produce inaccurate, incomplete, or missing data due to device error, poor sensor contact, patient non-compliance, or connectivity failure. Clinicians must apply independent clinical judgement when interpreting wearable data and must not use wearable data as a substitute for clinically validated measurements. The absence of wearable data must not be interpreted as confirmation that a patient is clinically stable.

IT security

Users must secure their devices with PIN, password, or biometric lock. Loss or theft of a device with active session access may result in unauthorised access to patient data.
Secure transfer protocols are used for all data transmission. However, use of unsecured or public networks without adequate protection increases the risk of data compromise.
In the event of a suspected data breach or unauthorised access, contact the manufacturer immediately at the address listed in Section 1.

Reporting of serious incidents

If a serious incident occurs in connection with the use of this device, it must be reported to the competent authority in the EU/EEA member state where the incident occurred, and to the manufacturer at: Youwell AS, C. Sundts gate 17, 5004 Bergen, Norway. E-mail: post@youwell.no
In Norway, serious incidents are reported to Direktoratet for medisinske produkter (DMP): www.dmp.no

12. Electronic Instructions for Use (eIFU)

This Instructions for Use is provided electronically (eIFU) in accordance with EU Regulation 2021/2226.
The current and all 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 above prevails.
A paper copy of this Instructions for Use can be provided upon request, free of charge, within 7 calendar days, by contacting the manufacturer at the address listed in Section 1.

Available language versions

This IFU is available in the following languages:

• English (master version)
• Norwegian (Bokmål)
• Danish
• Swedish
• German

Language versions are maintained and controlled in accordance with QP-0022 Labelling. The English master version prevails in case of discrepancies between language versions.

Markets

The Youwell Platform is currently made available in Norway (primary market), Denmark, Sweden and Germany.

13. Relationship to supplementary materials

Supplementary support documentation is available directly within the platform via the integrated knowledge base, accessible through the Help button. The knowledge base is also available at https://support.youwell.no.
These materials do not replace this Instructions for Use. In case of discrepancy, this IFU prevails.

14. Version information

IFU version: v1.5
Language: English (master)
Date of issue: October 22, 2026

IFU Revision History

Version	Date	Description of change
v1.0	2026-02-03	Initial release
v1.1	2026-04-09	Updated to address NC#TD02-B, NC#TD02-C, NC#CL11, NC#CL16: added medical indications and clinical benefits, minimum hardware/software requirements, expanded residual risks aligned with Hazard Analysis, added serious incident reporting section, clarified available language versions.
v1.2	2026-04-16	Updated to address NC#TD02-B and NC#TD02-C. Section 8: added guidance on when patients should consult a healthcare professional. Section 9: added training recommendation. Section 10 (new): added technical description of system architecture per IEC 82304-1 §7.2.2.10. Section 11 (prev. 10): expanded residual risks to align with Hazard Analysis device labelling column, including threshold review, reminders, new programme introduction, EHR data consistency, and crash/restart guidance. Section 2: added performance characteristics per GSPR 23.4(e). Updated to reference integrated knowledge base per NC#TD02-F. Added symbol 5.4.4 (Caution) under chapter 7.
v1.3	2026-07-01	Version 1.3 — 2026-07-01 — Added wearable device data advisory statements to address NC#TD05-E (second round, part b). Section 8 (Limitations of use): added statement that wearable sensor data displayed through third-party device integrations is consumer-grade, has not been clinically validated as a medical measurement, and is supplementary and advisory only. Section 11 (Residual risks, System availability and data integrity): added statement describing that wearable device data is sourced from consumer devices via third-party middleware and may be inaccurate, incomplete, or missing due to device error, poor sensor contact, patient non-compliance, or connectivity failure; clinicians must apply independent clinical judgement and must not use wearable data as a substitute for clinically validated measurements; absence of wearable data must not be interpreted as confirmation of clinical stability. Section 11 (Residual risks, Clinical supervision and decision-making): added statements on user interface clarity (in-app guidance/tooltips, support contact) and on alert-fatigue mitigation (notification batching, recommendation to review the clinician portal on a regular schedule rather than relying solely on notifications), addressing Hazard Analysis Lines 9 and 12 per NC#CL11. Section 2: replaced the diagnosis-specific "Medical indications" and "Clinical benefits" subsections with platform-only language consistent with Claims Matrix v1.1 (C1–C4) and CER v1.2, removing the previous list of specific medical conditions; the platform now states explicitly that it does not carry a diagnosis- or condition-specific medical indication, consistent with the platform-only claims strategy adopted to resolve NC#CL04. Section 11 (Residual risks, System availability and data integrity): added disclosure of infrastructure-level denial-of-service events and release-induced configuration-reset risk as residual risk categories, consistent with the CER's "Analysis of the risk and safety" section (Major-rated software-failure hazards and realised post-market incident categories).
v1.4	2026-09-25	Updated to address NC#CL09 and NC#CL14 (TÜV SÜD TD Round 2). Section 2: "Clinical benefits" replaced by "Clinical benefit", stating that the platform has no direct clinical benefit, that any benefit to the patient is indirect, and that claims C1–C4 are performance, usability and safety claims, consistent with CEP v1.3 §3.4 and CER v1.3 §5.1.1. Section 2 (Performance characteristics, risk indicator display) and Section 11 (Clinical supervision and decision-making): clarified that flagging for validated questionnaires follows the instruments' published cut-off values (or a manufacturer-defined rule where no cut-off is published) and that clinician-configured thresholds apply to other health registrations, consistent with the Module Framework Specification v1.1. Section 11: the wearable device data paragraph moved from "Content and program configuration" to "System availability and data integrity", consistent with the v1.3 revision description and the language versions. No other changes.
v1.5	2026-10-22	Updated following issuance of the EU Quality Management System Certificate (MDR Annex IX Chapter I) by TÜV SÜD Danmark ApS (NB 2443) on 2026-10-15, and addition of Germany as a market. Symbol table, CE entry: "Certificate pending issuance" replaced by the issued certificate number G11DK 136913 0002 Rev. 00 and its validity period; notified body identifier corrected from "CE2443" to "NB 2443". Symbol table, manufacturer entry, and Section 11 (Reporting of serious incidents): manufacturer name corrected to the legal manufacturer name Youwell AS. Section 12: German added to the list of available language versions; Germany added to the list of markets. No other changes.