Instructions for Use, Pending MDR Class I Certification

document version 1 0 (latest) date of issue 2026 02 26 device name autoscriber device type software as a medical device (samd) regulatory status class i medical device under eu mdr (2017/745) manufacturer autoscriber b v high tech campus 6a, 5656 ae eindhoven, the netherlands intended use autoscriber is a software based medical device intended to support licensed healthcare professionals in the documentation of clinical encounters within professional healthcare environments the software captures spoken interactions during medical consultations and converts them into structured draft clinical documentation the generated output is intended solely as preliminary documentation support and must be reviewed, verified, and approved by the healthcare professional prior to incorporation into the patient’s electronic health record (ehr) autoscriber does not perform clinical interpretation, diagnostic analysis, risk stratification, therapeutic recommendations, or decision support the software does not replace professional clinical judgement and does not autonomously initiate or modify patient care decisions the intended users are qualified healthcare professionals responsible for reviewing and finalising all documentation prior to use in patient care indications use during or immediately following clinical encounters to support the preparation of draft documentation for professional review contra indications not intended for use by patients or lay persons not intended to be used as an autonomous documentation or decision making system must not be used without professional review of generated outputs not intended for use as a sole source of clinical information not intended for use in emergency situations where immediate documentation is critical and system availability cannot be ensured not intended to provide diagnostic or therapeutic guidance patient target group no specific patient group the device may be used in consultations involving adult or paediatric patients, at the discretion of the healthcare professional intended users qualified healthcare professionals responsible for clinical documentation expected clinical benefits when used as intended, expected benefits relate to workflow efficiency and documentation support and may include improved efficiency in preparing draft clinical documentation reduced administrative workload associated with manual transcription improved consistency of documentation structure more timely completion of records compared to fully manual workflows autoscriber is intended to support documentation workflows only clinical responsibility remains with the healthcare professional at all times the expected benefits are realised only when users carefully review and verify all generated documentation before finalisation performance characteristics autoscriber converts captured audio input into structured draft text using automated speech recognition and natural language processing technologies performance is dependent on audio quality, speech clarity, and system availability software updates are deployed centrally under the saas model the current software version and release date are displayed within the application interface residual risks and undesirable side effects all risks related to the software device have been reduced as far as possible however, the following residual risks still apply risk of transcription errors due to speech recognition limitations or environmental conditions risk of inaccuracies or omissions in the note output due to natural language processing limitations risk of hallucinations due to the use of ai risk of temporary service unavailability or performance degredation due to cloud infrastructure risk of data transmission interruption due to these risks, outputs from autoscriber must be reviewed and the content verified before further processing or storing in the medical records cybersecurity & data protection – add section autoscriber is hosted within secure cloud infrastructure and uses encrypted data transmission protocols access is restricted to authorised users through authenticated login procedures users are responsible for maintaining the confidentiality of their login credentials installation, system requirements and usability autoscriber is delivered as software as a service (saas) through a standalone app, or integrated into an ehr no local installation, calibration, sterilisation, or physical assembly is required when used as a standalone application, a browser is required, with the following compatibility chrome safari ms edge additionally, to use autoscriber, users will need a microphone and stable internet connectivity warnings, precautions and limitations of use clinical responsibility autoscriber does not replace professional judgement users must review and correct all generated documentation accuracy limitations errors, omissions or misinterpretations may occur environmental considerations performance may be affected by loud background noise poor audio capture multiple speakers unstable internet connectivity system malfunction in the event of system malfunction or service unavailability, users should revert to standard manual documentation procedures reporting of serious incidents any serious incident that has occurred in relation to the device should be reported without undue delay to autoscriber b v high tech campus 6a 5656 ae eindhoven the netherlands https //support\@autoscriber com users within the european union should also report serious incidents to their national competent authority in accordance with applicable regulations