Euro­pean Com­mis­sion pub­lish­es updat­ed ver­sion of the Man­u­fac­tur­er Inci­dent Report (MIR)

On May 5, 2025, the Euro­pean Com­mis­sion released the Man­u­fac­tur­er Inci­dent Report (MIR) form, revi­sion 7.3.1, manda­to­ry from Novem­ber 2025, along with accom­pa­ny­ing XSD/XSL files, help text, and a changelog. 

The pass­word-pro­tect­ed PDF can be unlocked for trans­la­tion or sys­tem integration—stakeholders may request access via the Commission’s por­tal. In addi­tion to MIR 7.3.1, relat­ed tem­plates are avail­able for Field Safe­ty Cor­rec­tive Actions, Field Safe­ty Notices (includ­ing cus­tomer and dis­trib­u­tor replies and Q&As), Trend Reports, and Peri­od­ic Sum­ma­ry Reports. 

The doc­u­ments can be found here. 

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Effi­cient sup­port for med­ical device man­u­fac­tur­ers: mdi Europa and the EUDAMED database
• A clos­er look at MDCG 2023-3 on vigilance
• MDCG guid­ance on admin­is­tra­tive prac­tices and tech­ni­cal alter­na­tives until EUDAMED full functionality