Instructions for Use

1. Device identification

2. Regulatory status

Regulatory status: Medical device under Regulation (EU) 2017/745 (MDR). Nimble is currently placed on the market as a Class I device under the manufacturer's self-declaration. This Instructions for Use applies to Nimble as a Class IIa device and shall take effect upon issuance of a CE certificate by a Notified Body.

The conformity assessment for Class IIa classification is currently in progress. Nimble is not yet placed on the market as a CE-marked Class IIa device. This Instructions for Use will be updated to include the CE mark and Notified Body number once the certificate has been issued.

3. Intended purpose

Nimble is a Software as a Medical Device (SaMD) used by licensed healthcare professionals to monitor and follow up patients in specialist, secondary, or general care, by collecting structured patient-reported and clinician-entered data and presenting it to the supervising clinician for review.

The software enables healthcare professionals to operate digital follow-up pathways within manufacturer-validated functional frameworks (structured questionnaires and patient-reported outcome capture, threshold-based visual indicators, structured patient overviews, secure asynchronous patient–clinician communication, and — where established — interface to the patient's electronic health record). Within these validated frameworks, healthcare professionals configure pathway content and threshold values for their clinical context, while safety-critical functionality remains within boundaries defined and validated by the manufacturer.

Nimble is intended to support clinician-guided care, blended care (combining digital and in-person interactions), and structured remote follow-up where clinically appropriate. The software supports monitoring and follow-up by presenting patient-reported data, threshold-based indicators, and trends to the supervising clinician for review.

The software does not perform autonomous diagnosis, triage, or treatment decisions. All clinical judgement and responsibility remain with the supervising healthcare professional. All outputs require independent clinical interpretation by an authorised healthcare professional before any action is taken.

Nimble is intended for use in the monitoring of patients with chronic or complex conditions — that is, conditions that require ongoing structured follow-up in specialist, secondary, or general care. This includes conditions where timely identification of deterioration or change in patient status is clinically significant.

The software is not intended for use in acute, critical, or rapidly evolving conditions where near-term clinical intervention is required.

4. Medical indications

Nimble is intended to support clinicians in delivering structured digital follow-up pathways for patients with chronic or complex conditions where remote patient monitoring and patient-reported outcome capture form part of accepted clinical care. This includes, but is not limited to, conditions in the following areas:

• Chronic somatic conditions: chronic obstructive pulmonary disease, heart failure, diabetes, inflammatory bowel disease, chronic kidney disease, rheumatic conditions, and other chronic diseases requiring structured follow-up between in-person consultations.
• Cancer follow-up: structured remote follow-up of cancer patients during and after active treatment, including symptom monitoring and survivorship pathways.
• Postoperative and rehabilitation follow-up: structured remote follow-up after surgery, including wound monitoring and post-discharge symptom registration, and rehabilitation pathways.
• Complex care coordination: structured follow-up of patients with complex care needs requiring coordination between specialist and primary care.

The software does not embed condition-specific diagnostic algorithms and does not determine treatment pathways. The clinical indication for use in any specific deployment is defined by the prescribing healthcare professional within the manufacturer-validated functional framework, and is set out in the deployment-specific clinical pathway documentation issued by the treating institution.

5. Clinical benefits

The intended clinical benefits of Nimble include:

• Structured digital follow-up of patients with chronic or complex conditions between in-person consultations
• Enhanced continuity of care through structured patient-reported and clinician-entered data captured over time
• Improved clinical prioritisation through threshold-based visual indicators that draw clinical attention to potential changes in patient status
• Timely identification of patient-reported deterioration through clinician-configured threshold values applied to patient-reported data
• Support for blended care models combining digital follow-up and in-person treatment

All clinical benefits are contingent on appropriate clinical supervision and correct configuration by a licensed healthcare professional within the manufacturer-validated functional framework.

6. Performance characteristics

Nimble performs the following functions in support of its intended purpose:

• Structured patient-reported outcome capture: The software captures structured patient responses to questionnaires, symptom registrations, and health registrations submitted via the patient-facing module, and presents aggregated data and trends to the supervising clinician.
• Clinician-entered clinical data capture: The software captures structured clinical observations and parameters entered by the supervising clinician, and integrates these with patient-reported data in a unified patient overview.
• Threshold-based visual indicators: The software calculates and displays threshold-based visual indicators (colour-coded flags) based on clinician-configured threshold values applied to patient-reported and clinician-entered data. Indicators are advisory only and must always be interpreted by a qualified clinician.
• Structured patient overviews and prioritisation: The software presents structured patient overviews to the supervising clinician with deviation markers and prioritisation cues that enable clinical assessment, prioritisation, and follow-up.
• Secure asynchronous patient–clinician communication: The software supports asynchronous structured messaging between patients and their care team within the digital follow-up pathway.
• Electronic health record interface: Where integration has been established, the software exchanges structured clinical information with the patient's electronic health record via documented integration interfaces.

The software does not perform diagnostic computations, autonomous clinical assessments, or physiological measurements. All performance is contingent on correct configuration by a licensed healthcare professional within the manufacturer-validated functional framework.

7. Intended users

Nimble is intended for two distinct user groups, as defined in IMDRF/SaMD WG/N81 FINAL:2025:

Primary users - licensed medical professionals (non-physician and physician)

• Authorised healthcare professionals in specialist, secondary, or general care settings, including registered nurses, specialist nurses, physiotherapists, and other licensed non-physician clinical personnel, as well as general practitioners and specialist physicians involved in the patient's follow-up. These users configure, prescribe, and supervise digital follow-up pathways for patients within the manufacturer-validated functional framework. They are responsible for reviewing software outputs, exercising clinical judgement, and making all clinical decisions.

Secondary users - lay users / non-clinical users

• Patients in the primary tier (≥18 years) or, under conditions defined in §8, the adolescent tier (13–17 years), who use Nimble People under supervision of a licensed healthcare professional to submit patient-reported outcome measures and communicate asynchronously with their care team, within a follow-up pathway prescribed by a clinician. Next of kin or designated patient representatives may act in this capacity where approved by the treating organisation, including on behalf of children under 13 per §8. These users are not required to have medical qualifications to interact with the software.

8. Intended patient population

Nimble is intended for use in a specific subgroup of the general patient population, structured into three tiers:

Adults (≥18 years) - primary intended patient population. Nimble is primarily intended for use by patients aged 18 years and above who are under active specialist, secondary, or general care follow-up and who are able to self-report symptoms digitally, or for whom a next of kin or representative has been designated to do so.

Adolescents (approximately 13-17 years) - permitted under conditions. Use of Nimble in adolescents aged approximately 13 to 17 years is permitted only where explicitly defined in a deployment-specific Instructions for Use addendum issued by the treating institution under documented clinical governance, under clinician supervision, and with appropriate consent. The patient-facing module (Nimble People) shall not be used independently by adolescents in this group; clinician supervision and caregiver involvement, as appropriate to the clinical pathway, are required.

Children (under 13 years) - not intended for independent use. Nimble is not intended for independent use by children under 13 years of age. The software has not been evaluated for independent use in this population and its use as the patient-facing modality is not supported. Where a clinical pathway involves a child under 13, data may be submitted by a designated next of kin or representative on the child's behalf, under the same conditions as the adolescent tier above; the child shall not interact with the patient-facing module independently.

Clinical organisations wishing to deploy Nimble outside the primary tier (≥18 years) must contact the manufacturer and ensure that a documented risk assessment and supplementary clinical evaluation has been completed prior to any such use.

9. Intended use environment

Nimble is intended for use across two distinct environments:

Healthcare environment: The clinician-facing module (Nimble Clinic) is intended for use in specialist, secondary, and general care institutions, including hospital outpatient departments, specialty clinics, general practice offices, and virtual healthcare settings where structured remote patient monitoring has been established as part of the clinical pathway.

Home and community environment under clinician supervision: The patient-facing module (Nimble People) is intended for use by patients in their home or other non-clinical settings, under supervision of a licensed healthcare professional, as part of a digitally supported care pathway initiated and managed by the treating institution.

Nimble Clinic is accessed via supported web browsers and as a native mobile application (iOS and Android). Nimble People is accessed via supported web browsers and as a native mobile application (iOS and Android), on commercially available devices with internet connectivity. The device is not intended for offline use.

10. Contraindications

Nimble must not be used for:

• Autonomous diagnosis, triage, or clinical decision-making without professional oversight
• Acute, emergency, or time-critical clinical situations requiring immediate or near-term intervention
• Independent use by children under 13 years of age (use under supervision of a designated representative permitted per §8)
• Situations requiring immediate medical intervention or as a substitute for direct clinical contact
• Use as the sole basis for any clinical decision without independent clinical interpretation by an authorised healthcare professional

Nimble does not provide autonomous diagnosis, prognostic classification, or treatment recommendations. All outputs require review and clinical interpretation by an authorised healthcare professional before any clinical action is taken.

Nimble is not intended to be the sole clinical tool in the management of any patient condition. It shall be used as an adjunct to — not a replacement for — established clinical practice and professional clinical judgement.

Nimble is not validated for use outside the populations defined in §8. Clinical organisations wishing to extend deployment outside these tiers must contact the manufacturer and ensure that a documented risk assessment and supplementary clinical evaluation has been completed prior to any such use.

11. Warnings and precautions

12. When to consult a healthcare professional

Patients shall consult their supervising healthcare professional if:

• symptoms worsen or new symptoms arise during the course of a follow-up pathway;
• they experience distress in connection with the content of the digital follow-up pathway;
• they are uncertain whether the digital follow-up pathway remains suitable for their current clinical condition;
• they have not received a response from their care team within an expected timeframe.

Nimble is not a substitute for direct clinical contact and shall not be used in situations requiring immediate medical attention. In such situations, patients shall contact their healthcare provider directly or, in the event of an emergency, the national emergency medical service.

13. Residual risks the user should be aware of

Residual risks associated with Nimble 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 shall be aware of the following:

• Delayed or unprocessed patient submissions: Technical failure or network outage may delay receipt of patient-submitted forms and messages, and received items may remain unprocessed. The healthcare organisation shall have procedures ensuring that received data is reviewed within the intended follow-up interval, and that expected patient responses that do not arrive are followed up.
• Incorrect prioritisation: The healthcare professional is responsible for the final clinical assessment. Threshold values are configurable by the responsible clinician and must be reviewed regularly to ensure clinical appropriateness; incorrect threshold configuration may result in missed indicators or false indicators.
• Incorrect patient identification: If a clinician is not attentive when switching between multiple patient records, there is a risk that clinical data from one patient is viewed or acted upon in the context of another patient, which could result in a missed clinical finding or an incorrect diagnosis or treatment decision. Patient identity (name and national ID number) is persistently displayed on all clinical screens to support verification, and the system enforces authorisation controls to prevent unauthorised cross-patient access. Clinicians shall verify the displayed patient identity before acting on clinical information or making documentation entries, particularly when managing multiple patients in parallel.
• EHR integration failure: In the event of failure in the integration with the electronic health record, patient-submitted information may become unavailable in the records system. The healthcare organisation shall have routines for detecting and managing such failures, and shall verify data consistency before acting on integrated data.
• Use beyond the manufacturer-validated functional framework: Clinical pathways must be configured and delivered within the manufacturer-validated functional framework. Pathways or threshold configurations that fall outside this framework shall not be introduced without proper clinical review and validation by the responsible healthcare organisation.
• Patient-reported data quality: Self-reported data may be incomplete or inaccurate. Patient-reported data, questionnaire results, and progress information must be reviewed and interpreted by a clinician.
• Misinterpretation due to data gaps: Sparse or missing patient registrations may create a false impression of clinical stability in trend displays. The system visually distinguishes gaps in registered data from actual values, and applies consistent anomaly marking across all display surfaces, to reduce this risk. The healthcare professional shall account for data gaps when interpreting trends and shall not assume clinical stability based on an absence of registrations alone.
• System availability: The platform may be temporarily unavailable due to scheduled maintenance or unplanned outages. The healthcare organisation shall have alternative follow-up procedures for time-sensitive clinical situations.
• Crash or unresponsive application: If the application crashes or becomes unresponsive, the user shall restart and re-authenticate. Patient data is automatically saved. If data appears inconsistent or incomplete after a restart, the user shall contact Diffia AS support before acting on the information.
• Device security: Loss or theft of a device with an active session may result in unauthorised access to patient data. Users shall secure their devices with PIN, password, or biometric lock, and shall not disable session timeout or automatic logout features.

14. Undesirable side effects

An undesirable side effect is an unwanted effect that may arise when Nimble is used as intended, in the absence of any device failure or use error. Harms arising from device failure or use error are residual risks rather than side effects; these are assessed through the manufacturer's risk management process and set out in §13.

Nimble produces no physiological or biological side effects. The device delivers no energy or substance, performs no physiological measurement or intervention, and does not come into contact with tissue or bodily fluids.

The following undesirable side effects may arise from the intended use of the device as a structured digital follow-up tool, and are inherent to the paradigm of patient self-reporting and threshold-based clinical review rather than to any defect in the software:

• Increased symptom awareness or anxiety in the patient. Repeated structured self-reporting of symptoms may increase the patient's attention to their own condition and, in some patients, cause worry or heightened symptom focus.
• Expectation of continuous surveillance. A patient may assume that submitted data is reviewed immediately and continuously, and consequently delay contacting the care team or ordinary emergency services when their condition changes.
• Reduced direct clinical contact. Where digital follow-up replaces rather than supplements scheduled in-person consultations, clinical findings that depend on direct examination or on unstructured conversation may go unobserved.

These effects are addressed through the information in this Instructions for Use, through the requirement for clinician supervision of every follow-up pathway, and through the contraindication of Nimble as the sole basis for any clinical decision (§10). Patients who experience worry or discomfort in connection with a digital follow-up pathway should contact their care team, per §12.

15. Inputs and outputs

Inputs

• Patient-reported outcome measures
• Clinician-entered clinical data
• EHR data (where integration has been established)

Outputs

• Visual indicators (advisory only)
• Threshold-based indicators
• Structured patient overviews

The outputs:

• are not clinical conclusions
• require clinical review

Performance and limitations

Nimble is a presentation and alerting software. The software does not perform diagnostic computations and does not have a measuring function. Indicators are generated based on pre-defined threshold values configured by the healthcare organisation. Indicator latency depends on the timing of the patient's data submission and system availability. Diffia AS monitors service availability and publishes statistics in accordance with the applicable service agreement with the healthcare organisation.

16. Instructions for use (summary)

1. The patient submits data via the patient-facing module
2. Data is transferred and structured in the system
3. The clinician reviews the patient overview
4. The clinician assesses the need for clinical action

For safe and correct use, the following minimum requirements shall be met:

• A licensed healthcare professional must prescribe and configure all follow-up pathways for patients.
• Pathway configuration must remain within the manufacturer-validated functional framework.
• Patient-reported data and threshold-based indicators must be reviewed and interpreted by a qualified clinician.
• Patients shall only use follow-up pathways explicitly assigned to them by a clinician.
• Secure authentication and role-based access control must be used as intended.
• Users must have sufficient language comprehension and digital literacy to use the digital interface.
• Training in the use of Nimble is recommended prior to first clinical use.

17. Functionality

Nimble consists of two user interfaces:

Nimble Clinic is available to healthcare professionals and provides access to:

• Patient lists and follow-up status
• Patient-submitted information (forms, measurements, messages)
• Pathway and group administration

Nimble People is available to patients and next of kin and provides access to:

• Submission of health information and forms
• Communication with the care team
• Overview of the follow-up pathway

Detailed user guides are available within the respective Nimble Clinic and Nimble People sections of the help portal.

18. Technical description

Nimble is a cloud-hosted Software as a Medical Device consisting of two integrated user interfaces and a shared backend services layer:

• Nimble Clinic: application for licensed healthcare professionals, available as a web application and as a native mobile application (iOS and Android).
• Nimble People: patient-facing application, available as a web application and as a native mobile application (iOS and Android).
• Backend services layer: provides authentication, data storage, scheduling, notifications, and integration interfaces.

All communication between client and backend is encrypted using TLS 1.2 or later. Data is stored encrypted at rest. Authentication is performed via the healthcare organisation's identity provider (SSO/SAML) for healthcare professionals and via secure login with national electronic ID (BankID or equivalent) for patients. The platform operates with tenant isolation between healthcare organisations.

Nimble Clinic is accessible only via the Norwegian Health Network (Norsk helsenett, NHN). Nimble People is accessible over the public internet.

No local installation is required beyond download of the Nimble People mobile application from Apple App Store or Google Play Store.

19. System requirements

Minimum hardware requirements:

• Device: PC, Mac, tablet, or smartphone (commercially available)
• Screen resolution: minimum 1280 × 720 pixels (PC and Mac); minimum 320 × 480 pixels (Nimble People)
• Internet connection: stable broadband or mobile data connection (minimum 5 Mbps recommended)

Minimum software requirements - web (Nimble Clinic and Nimble People):

• Current versions of modern browsers, including, but not limited to Microsoft Edge, Google Chrome, Mozilla Firefox or Apple Safari with JavaScript enabled

Minimum software requirements - native mobile applications (Nimble Clinic and Nimble People):

• iOS: version 15.6 or later (iPhone and iPad)
• Android: version 12 or later

Network requirements:

• Nimble People is available over the internet
• Nimble Clinic is only accessible via the Norwegian Health Network (NHN)

EHR integration:

Nimble can be integrated with electronic health record systems for the exchange of structured health information. Integration has been validated against DIPS Arena. Other EHR systems may be supported following separate validation. Data exchange takes place via HL7 FHIR-based interfaces or equivalent standardised integration protocols agreed with the healthcare organisation. In the event of integration failure, data may become unavailable in the records system - see section §13 (Residual risks the user should be aware of).

IT security:

• Authentication is performed via the healthcare organisation's identity provider (SSO/SAML) for healthcare professionals and via secure login with national ID (BankID or equivalent) for patients
• All communication is encrypted (TLS 1.2 or later)
• Diffia AS is responsible for application security and protection against unauthorised access in accordance with NS-EN ISO/IEC 27001:2022
• The healthcare organisation is responsible for access management, user administration, and securing the local network environment
• Nimble shall not be accessed over unsecured or public Wi-Fi networks without a VPN or equivalent protection
• A stable internet connection is required; the solution does not support offline use
• Devices used to access Nimble should be protected with PIN, password, or biometric lock
• Session timeout and automatic logout features shall not be disabled

In the event of a suspected data breach or unauthorised access, the healthcare organisation shall contact Diffia AS immediately at support@diffia.com.

20. Maintenance and updates

Nimble is delivered as a software service (SaaS) and is updated on an ongoing basis. Updates may affect functionality. New versions are made available by agreement and with approval from the healthcare organisation. The healthcare organisation is responsible for informing clinical users in advance of new versions.

Expected service lifetime: Diffia AS commits to maintain and support Nimble for a defined minimum expected lifetime of 5 years from the date of MDR Class IIa certification, reassessed at each re-certification. In the event of end-of-life, customers will be notified at least 12 months in advance, and support and customer-data export will be provided in accordance with the manufacturer's device lifetime assessment.

21. Incident reporting

Errors, incidents, or deviations shall be reported to:

• the treating institution
• the manufacturer (Diffia AS - support@diffia.com)

Serious incidents that may be related to the use of Nimble shall additionally be reported to:

• The Norwegian Medical Products Agency (DMP): www.dmp.no
  The reporting portal at the Norwegian Health Network: www.melde.no

Reporting to the competent authority is regulated by MDR Article 87. The healthcare organisation and Diffia AS collaborate on notification as required.

22. Manufacturer information

23. Electronic IFU - notice

This Instructions for Use is made available in electronic form. For medical device software delivered as a service (SaaS) without physical packaging, electronic provision of instructions for use is permitted in accordance with Regulation (EU) 2021/2226, Article 3(3), which applies to medical devices where the manufacturer can ensure that the user has access to the electronic instructions for use at all times.

The current version of this Instructions for Use is available at: https://www.diffia.com/ifu
The electronic version is the official version. In case of discrepancies between copies, the version available at the URL above prevails.

If you wish to receive a paper copy of this Instructions for Use, please contact the manufacturer at support@diffia.com. A paper copy will be sent free of charge within 7 calendar days.

Date of issue: September 23rd, 2026 - IFU revision: 2026.6

24. Available language versions and markets

This Instructions for Use is available in the following languages:

• English (master version)
• Norwegian (Bokmål)

Language versions are maintained and controlled. The English master version prevails in case of discrepancies between language versions.

Markets: Nimble is currently made available in Norway.

25. Relationship to supplementary materials

Supplementary materials may include detailed user guides for Nimble Clinic and Nimble People, training resources, and operational guidance.

Supplementary materials do not replace this Instructions for Use. In case of discrepancy between supplementary materials and this Instructions for Use, this Instructions for Use prevails.

26. Symbols used in labelling

The following symbols are used in this Instructions for Use and in the labelling of Nimble in accordance with ISO 15223-1:2021 and Regulation (EU) 2017/745.