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MDR Art. 87 · Vigilance

Missing a reporting deadline is the most expensive mistake in post-market. medairon keeps it from getting that far.

Deadline calculated automatically — overdue shows red in the dashboard. The incident PDF records when you became aware, how you assessed reportability and why. You file the report itself using the competent authority's own form.

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From incident to a documented reportability decision Flow diagram: from scattered incident data — incident date, device/UDI, awareness date, severity and market — medairon produces, in one click, an incident PDF with the reportability decision and the reporting deadline of 2, 10 or 15 days calculated under MDR Art. 87. Incident data Incident date Device / UDI Awareness date Severity & market medairon Deadline under MDR Art. 87 One click Incident PDF Decision + deadline Due 2 · 10 · 15 days Export as PDF & XML

The deadline follows from the incident

medairon maps each incident to the applicable paragraph of MDR Art. 87 and derives the deadline — the values support your compliance work but do not replace your professional assessment.

2 days
MDR Art. 87(4)

For a serious public-health threat.

10 days
MDR Art. 87(5)

For death or serious deterioration of health.

15 days
MDR Art. 87(3)

For other serious incidents.

How it works

  1. 1

    Capture data

    Record the incident, device/UDI, awareness date, severity and affected markets.

  2. 2

    Deadline calculated

    Reportability checks the reporting obligation and calculates the deadline under MDR Art. 87.

  3. 3

    Export the incident PDF

    Incident PDF (PDF/A-3b) with incident, assessment and action data, ready to export.

What you get

  • Incident PDF (PDF/A-3b) with the awareness date, the reportability decision including its rationale, and the deadline calculated under MDR Art. 87.
  • Calculated deadline with a red dashboard status when overdue.
  • A complete audit trail across capture, assessment and export.

Instead of crisis research under deadline pressure

Instead of researching, in a crisis, whom to report to and by when — medairon supports your MDR compliance work with deadline, decision record and audit trail in one place.

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