This section fulfills the EU MDR requirement for Instructions for Use (IFU) for software medical devices.
Device Identification
Device Name: Noteless – AI Medical Scribe Platform
Medical Device Status: This software is a medical device.
ISO 15223-1 symbol: Medical device
Manufacturer: Noteless AS, Gaustadalléen 21, 0349 Oslo, Norway
Contact: [email protected]
Intended Purpose
The Noteless - AI Medical Scribe Platform is a reusable software device. It is intended to assist healthcare professionals with clinical documentation by automatically transcribing and summarising patient consultations into structured medical notes.
Based on the transcription, the system generates drafts of precise and high-quality structured notes. This includes functionality for automatically inserting relevant medical phrases to further support healthcare professionals in their documentation work. The device can also generate drafts of other document types, such as referrals and medical certificates, based solely on the information from the conversation.
Noteless is offered as a professional speech-to-text tool and documentation assistant. The solution is exclusively intended for administrative and documentation-related purposes. It is not intended for, and must not be used for, direct diagnostic, therapeutic, or patient-monitoring purposes. Responsibility for all medical assessments, diagnoses, and treatments rests fully with the healthcare professional.
Intended User and Use Environment
Intended user: The Noteless platform is intended for use by a broad range of healthcare professionals who engage in clinical consultations and need to document those encounters. It is not limited to general practitioners or doctors; it can be utilized by “all healthcare professionals” who have a duty to record documentation in line with their healthcare duties. Key user groups include:
General Practitioners (GPs)/Family Physicians: Primary care doctors are a major user group, as they have high documentation loads in everyday practice.
Medical Specialists: Doctors of various specialties (e.g., internists, pediatricians, psychiatrists, surgeons during clinic visits, etc.) may use Noteless to document patient consultations in their specialty areas.
Physiotherapists: Allied health professionals such as physiotherapists are frequently required to document patient sessions and progress; Noteless helps by transcribing patient-therapist conversations during therapy sessions.
Psychologists and Therapists: Psychologists, clinical counsellors, and other mental health professionals use Noteless to capture and summarize therapy session dialogues. This may be especially useful in talk-therapy contexts.
Other Allied Health Professionals: This user group includes occupational therapists, speech therapists, chiropractors, and similar roles where patient interaction needs to be recorded.
Nurses or Physician Assistants (if applicable): In some settings, nurses or PAs who conduct patient interviews or follow-ups could use the system to document those interactions.
Dentists: The product has seen adoption in dental clinics, where dentists dictate notes about examinations and procedures while conversing with patients.
Social/Child Protective Services Professionals: In a few cases, professionals in child protective services or social care who interview clients have used Noteless to document conversations. This is slightly outside typical healthcare, but the platform’s ability to document any interview or consultation reliably has found use in these areas as well.
It’s important to note that Noteless is intended for use by trained professionals, not by patients themselves. It is also intended for use in environments where privacy can be maintained (e.g., a closed office or consult room) because it involves recording potentially sensitive health conversations.
Intended use environment: The Noteless – AI Medical Scribe Platform is intended to be used in professional healthcare settings. These include:
Private Clinics and Practices: Individual or group medical practices (e.g., a GP clinic or a specialist’s office in private practice) where the clinician consults patients in an exam room or office.
Public Hospitals and Clinics: Hospital outpatient departments, ward rounds, or clinic settings in public healthcare systems.
Private Hospitals/Health Centers: Privately run hospitals or health centers can use Noteless in their consultation rooms similarly.
Telehealth/Virtual Consultation Environments: Noteless can also be used during virtual consultations (e.g., video or phone calls) by capturing the conversation audio via the computer’s microphone.
Home or Field Visits: If a clinician is doing a home visit or field consultation (using a mobile device), Noteless can be used via a mobile app or laptop to capture the conversation in that environment. Note: the device requires internet connectivity in order to function as intended.
Indications and contraindications:
Indications: Documentation of clinical consultations across all medical specialties.
Contraindications: None.
Version & Release
Current device version: 2.1.14 [LOT NUMBER]
Date of release: 17 Dec 2025
UDI Carrier
UDI: (01)05061111660007(11)17122025(8012)2.1.14
Precautions:
Clinicians must review and verify AI-generated notes before finalizing.
The operating environment (clinic, hospital, etc.) should have a secure computer or device with a microphone and internet access, as Noteless is a cloud-based service (requiring online connectivity for real-time transcription and AI processing).
Warnings
Not a replacement for clinical judgment; human review required.
Benefits:
Use of the device leads to:
Significant time savings on documentation
Improved clinician / patient focus
Higher quality documentation
Reduced administrative burden
Compatible Equipment & Minimum Requirements
Microphones
Works with built-in laptop microphones and standard external microphones.
For best results, use a Noteless Microphone or high-quality headset mic; place minimum 10–20 cm from speaker; minimise background noise.
Recommended capture: 16 kHz sample rate or higher, mono.
Operating Systems & Browsers
Windows 10/11, macOS 12+, or latest stable Linux distributions.
Google Chrome, Microsoft Edge, Safari or Firefox current stable release.
Allow microphone permissions in the browser; keep OS and browser updated.
Hardware & Network
Modern CPU (released within last 5 years) and ≥ 8 GB RAM.
Stable internet connection ≥ 5 Mbps up / 10 Mbps down; latency < 150 ms recommended.
IFU Version Control
IFU version: 2.0
IFU date of issue: 17 Dec 2025
Serious Incident Reporting
Any serious incident must be reported to the manufacturer and the competent authority of the Member State in which the user is established.
Report to manufacturer: Noteless AS ([email protected])
Also report to: The competent authority for your Member State (e.g., national medical device authority).
Please contact Noteless AS if you would like a paper copy of the Help Centre information.
Last updated: 17 Dec 2025
This IFU is provided digitally to avoid duplication with packaged leaflets and will be maintained in this Help Center section.