MIR 7.3.1 has been Mandatory in the EU since 1 May 2026
The European Commission has suspended the application of the Manufacturer Incident Report (MIR) 7.3.1 as part of the PMSV reporting documents. Mandatory use has been in effect since 1 May 2026. According to the current notification dated 7 May 2026, only versions of the 7.3.1 series published from December 2025 onwards are permitted; older versions may no longer be used.
Changes and Technical Updates to MIR Form 7.3.1
Version 7.3.1 of the MIR form has been enhanced with new features, particularly to improve data validation. New features include the automatic duplication of free-text fields into a structured ‘Extra Fields’ section at the end of the form. In addition, a split-view function has been introduced, which facilitates the simultaneous editing and checking of content. Furthermore, help texts have been expanded, particularly to include field overviews and instructions on using the form in Adobe Acrobat.
Impact on Manufacturers and Regulatory Compliance in the Context of the MDR
Manufacturers and Responsible persons (PRRC) should adapt their internal vigilance and PMS processes to the updated requirements. The Commission is also providing accompanying technical files such as XSD and XSL schemas, as well as updated guidance documents. The aim of these updates is to ensure more consistent and technically uniform reporting of serious incidents within the EU MDR system.
Professional Support
Implementing the new MIR 7.3.1 requirements calls for careful adaptation of internal processes, as well as seamless technical and regulatory integration into existing PMS and vigilance structures. Particularly given the transition to mandatory application from 1 May 2026, it is advisable to review your own reporting procedures at an early stage in order to avoid the risk of inconsistencies or queries from regulatory authorities.
BEO BERLIN supports manufacturers and PRRCs in the practical implementation of the current requirements – from regulatory classification to operational integration into existing processes.
Please contact us if you would like to set up your PMS processes securely, efficiently and in compliance with regulations.
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