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
(3022)
Manufacturer: Noteless AS, Storgata 5, 0155 Oslo, Norway
Contact: [email protected]
Intended Purpose
The Noteless - AI Medical Scribe Platform comprises two core clinical functionalities, each with a clinical purpose, in one Software as a Medical Device product. The intended purposes of each function are outlined below:
Ambient Scribe: The ambient scribe function is intended to assist healthcare professionals with clinical documentation by automatically transcribing and summarising patient consultations into structured medical documentation and suggesting appropriate codes from recognised clinical coding systems, based on the consultation transcription. The input data is the audio recording of the patient-clinician consultation. Output data is presented as structured medical documentation, such as consultation notes and referral letters, and suggested codes from recognised clinical coding systems.
Assistant function: The Assistant function is intended to retrieve, summarise, and present clinical information from a patient’s medical note history, such as prior investigations and diagnoses, based on prompts entered by a healthcare professional. This function may also be used to create discharge notes from
information available in a patient's Electronic Health Record relating to a specific inpatient admission. The input data is clinical documentation for a single patient stored in an Electronic Health Record, and the healthcare professional’s query. The output data is the summarised clinical information relevant to the healthcare professional’s query, with reference to the associated clinical documents / reports or, when used for discharge summary creation, the discharge note.
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: The Noteless – AI Medical Scribe Platform is indicated for:
The documentation of clinical consultations.
The summarisation of unstructured EHR data into clinical documents such as discharge notes.
The retrieval of clinical information from patient notes or within an EHR.
Contraindications: None.
Version & Release
Current device version: 3.1
Date of development: 29.06.2026
UDI Carrier
UDI: (01)05061111660007(11)29062026(8012)3.1
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
There are no unacceptable risks, contraindications, or undesirable side-effects.
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: 3.0
IFU date of issue: 29 June 2026
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).
Information label can be found here: Information about medical device.
Please contact Noteless AS if you would like a paper copy of the Help Centre information.
Last updated: 06 July 2026
This IFU is provided digitally to avoid duplication with packaged leaflets and will be maintained in this Help Center section.