1. Manufacturer Information
Product: Journalia AI Scribe
Manufacturer: Journalia AS, Parkveien 12, 0350 Oslo, Norway
Device classification: Class I Medical Device (MDR 2017/745)
Version: v1
Basic UDI-DI: 709007150JSCRIBEFJ
UDI-PI: v1
eIFU location: https://intercom.help/journalia/nb/
Issue date: 05.02.2026
Support / vigilance contact: [email protected]
Reporting: Report serious incidents to the manufacturer and the Norwegian Medical Products Agency (DMP).
2. Intended purpose & clinical benefit
Journalia is a non-invasive Medical Device Software (MDSW) designed to assist healthcare professionals in the automated clerical documentation of clinical encounters.
Intended use: Automating transcription and structured summarization of clinical dialogue.
Clinical benefit: Reduction of administrative burden, prevention of clinician burnout, and standardized high-quality documentation, allowing for increased focus on patient care.
Clinical performance: Journalia AI Scribe identifies and summarizes medical intent from oral and written communication into structured draft notes.
3. Indications for use
Intended users: Licensed healthcare professionals / clinicians (GPs, specialists, psychologists, nurses, therapists) trained in clinical documentation standards. Outputs must be reviewed by healthcare professionals / clinicians before further use.
Patient population: Adults and children in all age groups receiving clinical care.
Use environment: Professional clinical settings (clinics, hospitals, home visits, or secure telemedicine) with suitable acoustic conditions, functioning hardware (PC, phone, tablet) and secure network connection.
4. Contraindications & limitations
No decision support: The software does not suggest diagnoses, recommend treatments, or flag medical emergencies ("red flags").
Non-interpretive: The tool does not interpret non-verbal cues, tone, or physiological states.
Clinician discretion: Do not use if the patient objects, or if the clinical context is too sensitive/complex for automated transcription.
5. Operating instructions
Informed consent: Inform the patient and obtain consent for audio capture according to local institutional policy. Use posters and/or information regarding communication available at journalia.no if needed.
Secure access: Log in using mandated two-factor authentication (e.g., BankID/Buypass).
Capture: Activate recording. Conduct the consultation naturally.
Draft generation: The system generates a structured draft based strictly on the dialogue/written information provided.
Review (Mandatory): The clinician must review, edit, and verify the generated draft. Accuracy must be confirmed against the actual clinical context.
Final validation & transfer to medical record: Verify the completeness of the final note and transfer content to EHR. Confirm the correct content for the correct patient is pasted in the EHR.
6. Warnings & residual risks
Warning: Use of drafts without active clinician revision is considered misuse. The clinician retains legal and clinical responsibility for the final medical record. Journalia AI Scribe is designed on the principle of “human-in-the-loop” to verify drafts.
Warning: Confirm the final text transferred to the EHR is correct and linked to the right patient.
Accuracy risk: Factors such as dialects, background noise, or multiple simultaneous speakers may affect transcription quality. Never rely on outputs without verification.
No autonomy: The software is a clerical aid only; it does not provide autonomous medical decisions.
Fallback: If the system is unavailable, use your organization’s standard manual documentation process.
7. Technical requirements & troubleshooting
Technical specifications
Hardware: Workstation, laptop, phone or tablet with an integrated or peripheral microphone.
Network: Stable internet connection (latency <150 ms).
Browser: Compatible with modern browsers (Chrome, Edge, Safari).
Troubleshooting
Check if the issue is covered in one of the online-help center articles: https://help.journalia.com/nb/.
If not covered or the issue remains, contact: [email protected]
8. Maintenance & security
Updates: Delivered automatically by the manufacturer. The current version is always visible within the application interface.
Cybersecurity: Users must ensure their hardware has active security updates and is used in a private environment to maintain patient confidentiality.
9. Reporting of serious incidents
Any serious incident occurring in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user is established (e.g., the Norwegian Medical Products Agency - DMP).
Manufacturer contact: [email protected]
10. IFU administration
IFU Version: 1.0 (English)
Effective Date: 2026-02-05
Accessibility: This IFU is maintained digitally at https://help.journalia.com. A paper copy can be requested at no extra cost via [email protected] and will be delivered within 7 days. If printed or downloaded, the user must verify use of the latest approved version available on the manufacturer website.