1 Introduction

Oracle Argus Safety provides a solution for Reporting Manufacturer Incident Report (MIR) for a device product that has received marketing authorization in the European Region.

The European Commission has released a new version of the Manufacturer Incident Report (MIR), version 7.2.1, which comprises of both PDF and XML report. The European Commission is planning to implement a new EUDAMED System which will accept MIR XMLs sent by Manufacturers and subsequently send out an acknowledgement which will be accepted/imported by the manufacturer’s Oracle Argus Safety system. EUDAMED Implementation is expected by 2022.

National Competent Authorities (NCA) will accept new MIR 7.2.1 PDF or XML report, and manufacturers will continue to follow the existing MIR processing workflow. Also, in some cases, MIR XML is required to be submitted to Notified Bodies (NB), by the Manufacturers.