medaironcompliance.engineered
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, with a finished MIR PDF in the official format. So you miss neither the deadline nor the form.

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From incident data to a finished MIR with a calculated deadline Flow diagram: from scattered incident data — incident date, device/UDI, awareness date, severity and market — medairon produces, in one click, a MIR PDF in the official format with a calculated reporting deadline of 2, 10 or 15 days under MDR Art. 87. Incident data Incident date Device / UDI Awareness date Severity & market medairon Deadline under MDR Art. 87 One click MIR-Form Official format 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 MIR PDF

    A finished MIR PDF in the official format, sections A–G, ready to export.

What you get

  • MIR PDF in the official format (PDF/A-3b), sections A–G.
  • 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, form and audit trail in one place.

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