Swissmedic has recent­ly intro­duced the new Man­u­fac­tur­er Inci­dent Report (MIR) form ver­sion 7.3.1 for report­ing seri­ous inci­dents involv­ing med­ical devices that was pre­vi­ous­ly pub­lished by the Euro­pean Com­mis­sion. Released on May 5, 2025, this updat­ed form reflects the lat­est EU require­ments on post-mar­ket sur­veil­lance and inci­dent reporting. 

Man­u­fac­tur­ers and Swiss autho­rized rep­re­sen­ta­tives must com­plete the form accord­ing to the Switzer­land-spe­cif­ic guide pro­vid­ed on the Swissmedic web­site. Although man­u­fac­tur­ers are encour­aged to adopt the new ver­sion imme­di­ate­ly, it will be manda­to­ry for all reports from Novem­ber 2025 onward. 

This update not only ensures a more stream­lined report­ing process, but also strength­ens patient safe­ty and com­pli­ance with inter­na­tion­al stan­dards. For fur­ther details, users are invit­ed to con­sult the full doc­u­men­ta­tion and guid­ance mate­ri­als avail­able on Swissmedic’s web­site.

Source: Swissmedic

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website