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    Report an Incident

    Users and healthcare professionals can report incidents, serious incidents, and suspected safety issues for the Dentio Practice Automation System.

    Report serious incident

    If you suspect a serious incident, report it without undue delay.

    Report serious incident: [email protected]

    Phone: +46702943177

    What counts as a serious incident?

    A serious incident means an incident that directly or indirectly led, might have led, or might lead to death, serious deterioration in a person's health, or a serious public-health threat. The definition follows Regulation (EU) 2017/745 (MDR) Article 2(65).

    Examples of what to report to Dentio:

    • A suspected serious incident related to Dentio's operation or output,
    • A significant malfunction that could affect safe use,
    • Recurring faults that may compromise safety in the clinical workflow,
    • Suspected cybersecurity or data-integrity issues,
    • Material deviations in AI-generated content (wrong patient or visit selection, incorrect speaker attribution, fabricated content) that were not caught during clinician review.

    Quality complaints, support questions without safety impact, and feature requests should be sent to standard support – see [email protected].

    What to include in the report

    To enable rapid triage, please share the following information where available:

    • Date and time of the event and when it was discovered,
    • Software version (shown under Profile → About Dentio, e.g. v1.7.0) and which workflow surface was active,
    • Description of the event in chronological order,
    • Actual outcome and potential outcome if different,
    • Impact on patient, user, or data integrity if known,
    • Whether human review, draft generation, structured output, or downstream transfer may have been affected,
    • Any immediate containment already taken (e.g. switch to manual documentation),
    • Reporter contact details for follow-up.

    Please do not include identifiable patient data in the email. If the investigation requires sharing clinical data, Dentio will initiate a secure channel.

    What Dentio does with reports

    • Triage without undue delay by Dentio's PRRC together with product and engineering owners.
    • Reportability assessment recorded in Dentio's internal Incident / Vigilance Assessment Record.
    • Root-cause investigation and any CAPA opening normally within 5 working days of the awareness date.
    • Reporter follow-up on a rolling basis throughout the investigation.
    • Risk-management file update within 10 business days of confirmation, where applicable.
    • Closure target 90 calendar days from the initial report or awareness date.

    Dentio's authority-reporting timelines

    Where the event is reportable, Dentio notifies the competent authority within MDR timelines:

    CategoryTime from awareness
    Serious public-health threat2 days
    Death or unanticipated serious deterioration of health10 days
    Other serious incident15 days
    Reportable trend (non-serious)Without undue delay

    Also notify the competent authority directly

    Users and healthcare professionals may – and in some cases must – also report suspected serious incidents directly to the competent authority, independently of Dentio's own report.

    • In Sweden: Läkemedelsverket via [email protected].
    • In other EU member states: reports should be sent to the competent authority in the member state where the user is established.

    The current release is limited to the Swedish market. If deployment expands, Dentio will update this page with the relevant reporting routes.

    Reporter confidentiality and data handling

    Personal data shared with Dentio in connection with an incident report is used only for vigilance, investigation, and follow-up of that specific report. Processing is governed by Dentio's Privacy Policy.

    Vigilance records – including report-specific correspondence – are retained for at least 10 years after the last device of this type is placed on the market, in line with MDR Article 10(8). Reporter contact details are not used for marketing or any purpose beyond vigilance.

    If you would prefer to remain anonymous, please indicate this in your email. Anonymous reports are processed, but the ability to follow up will be limited.

    Manufacturer contact details

    ← Back to MDR Classification