Device identification
Version IFU: 2.0
Last updated: 26.05.2026
Product name: Journalia AI Scribe
Device type: Medical Device Software, software-only device
Manufacturer: Journalia AS
Manufacturer address: Parkveien 12, 0350 Oslo, Norway
Manufacturer SRN: NO-MF-000051992
Risk class: Class I under Regulation (EU) 2017/745, Annex VIII Rule 11
Contact: [email protected]
This eIFU provides information for safe and intended use of Journalia AI Scribe. If this document has been printed, downloaded or saved locally, verify that you are using the latest approved version.
Intended purpose
Journalia AI Scribe is intended for use as a clinical documentation tool to assist healthcare professionals and authorised personnel with drafting structured clinical and care-related documents from user-provided consultations, dictation and written source material. By supporting the documentation process, the device is intended to reduce time spent on documentation and support accurate, complete and structured draft documentation. The device allows users to review, correct and edit suggested document content before further use. All outputs generated by Journalia AI Scribe are draft outputs only and must be reviewed and verified by the responsible professional user before approval, transfer to the electronic medical record or other further use. Journalia AI Scribe does not independently establish clinical facts, assess the patient’s condition, determine medical necessity or determine clinical action.
Clinical benefit
The medical purpose of Journalia AI Scribe is to support healthcare documentation as part of patient management. The intended clinical benefits are support for accurate and complete draft documentation, reduced documentation workload, and support for more consistent documentation structure. The clinical benefit depends on the responsible professional user reviewing, correcting where necessary and approving the draft before further use.
Intended users
Journalia AI Scribe is intended for trained professional users, including healthcare professionals and authorised personnel, who prepare, review or approve clinical and care-related documentation as part of their professional duties. Journalia AI Scribe is not intended for use by patients, relatives, lay persons or members of the public.
Patient population and use environment
Journalia AI Scribe may be used to support documentation of healthcare and care-related interactions with patients or service recipients. The device is not limited to a specific disease area, specialty, diagnosis, age group or treatment pathway. The patient or service-recipient population is determined by the professional context in which the responsible user performs documentation.
The device may be used in professional healthcare and care-related settings where confidentiality, privacy, secure access, suitable hardware, microphone access where audio is used, internet connectivity and professional review can be maintained. This may include clinics, hospitals, private practices, dental clinics, mental-health services, municipal health and care services, telehealth, home visits and similar professional environments. Journalia AI Scribe is not intended for emergency or acute decision-making situations.
Device description and performance characteristics
Journalia AI Scribe is a cloud-based software-only medical device that transforms user-provided spoken and/or written source material into draft clinical and care-related documentation. Supported source material may include consultation audio, dictated speech, typed text, pasted text, uploaded documents, PDFs or other written material provided or selected by the user. The device may be accessed through the web application and, where available, the mobile application. Where the mobile application is used, it functions as an audio input source. Journalia AI Scribe does not autonomously approve, finalise or create final patient record entries.
Residual risks
All identified risks have been reduced to acceptable levels through implemented risk control measures. The main residual risks are that generated draft documentation may be incomplete, inaccurate or contain unsupported content. Journalia AI Scribe provides draft documentation only and does not replace professional judgement, clinical assessment, legal responsibility or the professional user’s responsibility for final documentation. The responsible professional user must review, correct where necessary and approve all output before use.
Contraindications and excluded use
Journalia AI Scribe must not be used on its own to diagnose, treat, triage, monitor, prioritise, code, determine referral need or urgency, or make clinical decisions. The device is not intended for emergency or acute decision-making situations where the responsible professional user cannot review and verify the output before it is relied upon. The device may include diagnoses, assessments, plans, codes or referral-related content only when this is present in the user-provided source material or explicitly provided by the professional user. In such cases, the device is only transforming source material into draft documentation for review.
Warnings
Do not use generated output without verification. All output is draft output only and must be reviewed, corrected where necessary and approved by the responsible professional user before approval, transfer to the EMR, storage in a recordkeeping system or other further use. The responsible professional user remains responsible for final documentation and all clinical decisions.
Precautions
Output quality may be affected by poor audio quality, background noise, multiple speakers, incomplete source material, unclear context, unusual terminology, dialect or accent variation, poor-quality scans or user instructions that conflict with the source material or intended purpose. If the system is unavailable, produces unclear output or produces output that cannot be adequately verified, use the organisation’s normal manual documentation process.
Adverse device effects
No adverse device effects are known at this time.
Device deficiencies
No unresolved device deficiencies affecting safe and intended use are known at this time.
Training requirements
No formal product-specific training is required. Users should familiarise themselves with the device interface, documentation workflow, review requirements, warnings, limitations and local procedures before use.
Hardware, software and network requirements
Journalia AI Scribe requires a computer, tablet or supported mobile device capable of running the Journalia web application or mobile application. For browser-based use, the browser must be at least Chrome 110, Edge 110, Safari 16 or Firefox 115.
A stable internet connection is required. For audio input, dictation or real-time transcription, a recommended upload speed of at least 0.5 Mbps is required.
No local installation is required for the web application. Updates are delivered by Journalia.
A microphone is required where audio input, dictation or real-time transcription is used.
Users must access the device through an authorised Journalia user account.
The device must be used on devices and networks protected against unauthorised access according to local information-security procedures.
Preparatory steps
Before using Journalia AI Scribe, ensure that internet connectivity is available.
Log in using valid user credentials.
Where audio input is used, ensure that the microphone is connected, selected and permitted in the browser or device settings.
Select the relevant workflow or documentation template.
Ensure that the intended source material is available and suitable for the documentation task.
Operating instructions
Log in with an authorised user account.
Select the relevant workflow or documentation template.
Provide source material, such as consultation audio, dictation, typed text, pasted text or uploaded written material.
Generate the draft documentation.
Review, correct and approve the draft before transfer, storage or further use.
Confirm that approved content is transferred to the correct patient or service-recipient record and the correct record field.
Installation, start-up and shutdown
Journalia AI Scribe is a cloud-based software solution. No local installation is required for the web application. To start using the device, open a supported browser or the supported mobile application, navigate to Journalia, and log in using valid user credentials. To end a session, log out of the application and close the browser or application where appropriate. Updates are delivered by Journalia. No user installation of updates is required for the web application.
Accessory and combination use
Journalia does not supply physical accessories with Journalia AI Scribe. Where the mobile application is used, it functions as an audio input source for the documentation workflow. The professional review and approval workflow remains mandatory. Journalia AI Scribe may be used together with customer systems such as electronic medical record or recordkeeping systems, but does not autonomously create final patient record entries. The customer remains responsible for the final patient record and for determining what approved content is stored in the customer’s EMR or recordkeeping system.
System malfunction, troubleshooting and fallback
If audio is not captured, check microphone permissions, microphone selection, browser permissions and device settings. If output quality is poor, check source quality, audio quality and whether the source material is complete. Correct the draft manually or use manual documentation if the draft cannot be safely verified. If the system is unavailable, does not return output or behaves unexpectedly, use the organisation’s normal manual documentation process and contact Journalia support. Product notifications or messages may be displayed in the user interface. Users should follow on-screen instructions.
Support contact: [email protected]
Maintenance
No user maintenance is required.
Data handling and decommissioning
For privacy, data-processing, account deletion or data-removal information contact Journalia at [email protected].
Reporting product problems and serious incidents
Serious incidents must be reported to the manufacturer and the competent authority of the Member State in which the user is established. Contact: [email protected].
Electronic IFU and paper copy
This IFU is provided electronically and is accessible from the in-app “About” section. A paper copy of the current IFU may be requested at no additional cost by contacting Journalia at [email protected]. Journalia will provide the paper copy within 7 calendar days unless a shorter timeframe is required by applicable law or agreed with the customer.