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Q & A - new Manufacturer Incident Report (MIR) Form

In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website. The form introduced novel information requirements such as use of IMDRF adverse event terms and codes or trending data based on relevant similar incidents.


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MDSS GmbH

Schiffgraben 41
30175 Hannover
Germany

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