Instructions for Use

Device Identification

Intended Purpose

Vidd Software is an AI-assisted Software as a Medical Device (MDSW) intended to support healthcare personnel and individuals authorised by healthcare organisations in the creation, review, and management of clinical documentation within healthcare workflows.

All data processing occurs within secure and authorised healthcare IT environments or within certified data-processing infrastructures operated under formal agreements that ensure compliance with GDPR and applicable cybersecurity standards.

The software provides two primary functionalities:

Vidd Software is intended solely as a documentation support tool. The device facilitates efficient and standardised record-keeping, and is not intended to analyse clinical information, interpret symptoms, establish diagnoses, or provide therapeutic recommendations.

All content generated by the software constitutes draft documentation and must be reviewed, validated, and approved by an appropriately qualified person within the healthcare organisation before inclusion in the patient's official record or for any other clinical or administrative use.

Indications and Users

Expected Clinical Benefits

When used as intended, Vidd Software may provide the following benefits:

• Contributes to enhanced patient safety by improving the consistency of clinical documentation.
• Accurately transcribes clinical consultations from speech to text, ensuring reliable documentation of patient interactions.
• Effectively generates a comprehensive summary of the consultation, reducing the risk of missing crucial information.
• Allows clinicians to review and edit the generated content, ensuring the accuracy of the information stored in the patient's electronic medical record.
• Reduces the time spent on documentation, potentially increasing the time available for direct patient care.

All expected benefits are conditional upon correct use of the software and require that all outputs are reviewed and approved before inclusion in the EHR.

Warnings and Precautions

Vidd Software is a documentation support tool and must be used with care.

Warnings

• All text generated by the software constitutes draft documentation and must be reviewed, validated, and, where necessary, corrected before it is stored or used within the electronic health record (EHR).
• Do not rely solely on automatically generated text. The authorised user remains responsible for verifying that all information recorded is complete and appropriate.
• Ensure that the correct patient is selected before recording or saving any documentation.
• Risk of temporary software malfunction or data-processing interruption may, in rare cases, result in incomplete or delayed output. Users shall verify that documentation has been properly saved and exported before closing a session.

Precautions

• Automated transcription or summarisation may introduce errors, omissions, or phrasing that requires user adjustment.
• Do not copy or transfer unreviewed or unapproved draft content into official medical records or downstream systems.
• Operate the software only within authorised and secure IT environments, in accordance with institutional data-protection and cybersecurity policies.
• Verify microphone and system functionality before each use.
• Log out or close the session after use to prevent unauthorised access.

All identified risks related to the device have been reduced as far as reasonably possible. See Section 6 for information on residual risks.

Residual Risks

Despite implemented safety and quality controls, certain residual risks remain:

• Potential transcription or summarisation inaccuracies, resulting from inherent limitations of AI-based language processing (e.g., omission or misinterpretation of information).
• Incomplete documentation, if draft notes are not reviewed, approved, or successfully exported to the electronic health record (EHR).
• Risk of unauthorised access, if institutional login and logout procedures are not correctly followed.

All identified risks have been reduced as far as reasonably possible through design and process controls.

Compatibility and Deployment

Vidd Software operates as a web-based application within authorised healthcare IT environments.

The software may be deployed in authorised on-premises or cloud-hosted configurations, managed under formal data-processing agreements that ensure compliance with GDPR and institutional information-security requirements.

Temporary operational data may be stored securely for processing and system-performance purposes in accordance with local regulations and organisational policies.

Symbols and Abbreviations

Incident Reporting

In accordance with Article 87 of Regulation (EU) 2017/745, any serious incident related to the use of Vidd Software must be reported without undue delay to the manufacturer and to the competent authority in your country.

Contact Information

For technical assistance or further information about the EU Declaration of Conformity:

Regulatory Compliance

Vidd Software is classified as a Class I medical device in accordance with Regulation (EU) 2017/745 (MDR).

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