The EU manufacturer incident report (MIR) v7.3 is set to be published soon. The European commission has provided draft versions of the new MIR, due to be released any day now.
Are you ready for the change?
About the MIR Form
The MIR was developed to provide a solution for adverse incident reporting for products that were authorized in Europe and to create a path for data exchange with a future EUDAMED system, which will accept MIR XMLs.
MIR enables timely post market reporting of incidents to the European Commission. The MIR 7.3 for serious incidents for medical devices regulation (MDR) and in vitro diagnostics regulation (IVDR) was created to provide an effective and more transparent exchange of information between competent authorities, manufacturers and notified bodies within the EU.
The MIR (v 7.2.1) was last updated in January 2020. MIR 7.2.1 addressed various discrepancies between the PDF and XML format. This was released to report incidents under the EU directives and regulations for in vitro diagnostics and medical devices.
What To Expect in MIR 7.3
Changes coming to the MIR have been on the horizon since the release of 7.2.1. It was determined that there would be no changes to the MIR XML structure for a significant amount of time after 7.2.1. To ensure full compliance with EUDAMED, MIR 7.3 will include these modifications to the XML.
Among changes to the XML structure, it was noted that a draft of MIR 7.3 included a removal of UK AER due to Brexit, a new single selection for UDI Issuing Entity can be found and the splitting of the Become Aware Date into awareness date of incident and awareness date of reportability.
When Is this Happening?
Early information indicates that a 6-month transition phase will be associated with the publication announcement of version 7.3. This 6-month timeline indicates mandatory use at the conclusion of the transition phase. Regardless of the amount of time allotted, organizations must be aware of the impending changes and be prepared for the latest release.
Upon publication of the new MIR, the European Commission is expected to make the new MIR version available in the recently announced playground environment related to EUDAMED.
What Does this Mean for Your Organization?
To be prepared for the eventual release of MIR 7.3, companies should start aligning their systems to enable the completion of the new form. We at Sparta Systems continue to monitor the developments of MIR 7.3 and will take any steps to ensure compliance with these regulation changes.
Questions or comments? Reach out to us at email@example.com for more information related to the upcoming MIR 7.3 release.