Free MIR checker
Is this incident reportable, and how fast?
Paste a short description and the device category. You get the seriousness, the deadline, and a pass or fail on whether a Manufacturer Incident Report is required. No account. The email is asked for before the result is shown.
The five criteria
Serious if one of these is met.
The checker uses the same five criteria as the full draft, and the same deadlines: two days, ten days, or fifteen days. It does not show the narrative. That stays on the paid plans, where a PRRC can review every field.
1
Death
The incident led to a death. The reporting deadline is ten days, unless a public health threat makes it two.
2
Serious deterioration in state of health
A serious deterioration that has occurred. Ten days. A malfunction that might have led to one, without that outcome in the text, is treated as another serious incident: fifteen days.
3
Serious public health threat
Two days. This is the short clock, including a widespread device issue the description actually supports.
4
Unexpected serious incident
Serious, and not one of the clocks above. Fifteen days. A false critical reading during use usually lands here when no harm is described.
5
Incident requiring corrective action
A recall or other corrective action the description already names. Fifteen days, unless a shorter clock also applies.
Deadlines follow MDCG 2023-3 guidance for vigilance reporting under EU MDR 2017/745. The guidance index is published by the European Commission. This page is an indicative check for manufacturers. The PRRC remains responsible for the report that is actually sent.