Reporting Rules for MIR

MIR Report is submitted in PDF or XML format to Notified Bodies, National Competent Authorities and European Commission. MIR Reporting Rules are configured based on the reporting obligations in the European region for the manufacturer.

It is recommended that Marketed Device Licenses and European Countries are considered for Reporting rule configurations.

Below is the summary of Reporting Rule configurations samples for MIR. If the manufacturer has additional obligations, additional configurations need to be considered.

License Type	Report Form	Rule Name	Time Frame	Advanced Condition (AC)
Mkt Device	MIR (PDF)	Related Serious Incident 15 Day MIR Report	15	Health Impact not equal to F20, F21, F02
Mkt Device	MIR (PDF)	Serious Public Health Threat 2 Day MIR Report	2	Health Impact = Serious Public Health Threat (F20)
Mkt Device	MIR (PDF)	Death 10 Day MIR Report	10	Health Impact = Death(F02) or Unanticipated serious deterioration (F21)
Mkt Device	MIR (XML)	Related Serious Incident 15 Day MIR Report	15	Health Impact not equal to F20, F21, F02
Mkt Device	MIR (XML)	Serious Public Health Threat 2 Day MIR Report	2	Health Impact = Serious Public Health Threat(F20)
Mkt Device	MIR (XML)	Death 10 Day MIR Report	10	Health Impact = Death (F02) or Unanticipated serious deterioration (F21)

Note:

Refer to Section 5: FAQs on how MIR Reporting is handled for Non Serious Reportable Incidents and how MIR XML and MIR PDF is transmitted together to the same destination.