Revised Manufacturer Incident Reporting form and new Vigilance-related guidance documents published

Posted on 03.10.2019

The European Commission has published on its website the updated Manufacturer Incident Report (MIR) package which consists of the following documents:

• New manufacturer incident report (v7.2 PDF form)
• New manufacturer incident report for importing XML file with Adobe Professional
• New manufacturer incident report XSD files (for implementation in manufacturer’ databases)
• New manufacturer incident report help text
• Changelog file

The publication of the updated MIR form (v.7.2) does not change the timeline for mandatory use of this new integrated from as from 1 January 2020. That is because the version 7.2 form only contains some editorial changes compared to the previous one (7.1 of the MIR form) published at the end of 2018. For the specific changes you can consult the change log file.
The updated version of the MIR helptext file now contains a Field Map tab which helps the integration of the MIR fields into the internal IT systems and it facilitates the XML submission.
A Q&A document is also foreseen to be published to support the implementation of the MIR form.

Two additional Device Specific Vigilance Guidance documents, which are applicable immediately, were also published here:
• DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices
• DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices