The Euro­pean Com­mis­sion has recent­ly pub­lished a new report­ing tem­plate for seri­ous inci­dents under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) and Reg­u­la­tion (EU) 2017/746 on In Vit­ro Diag­nos­tic Med­ical Devices (IVDR) and inci­dents under the the Med­ical Devices Direc­tive 93/42/EEC (MDD), the Active Implantable Med­ical Devices Direc­tive 90/385/EEC (AIMDD) and the In Vit­ro Diag­nos­tic Med­ical Devices Direc­tive 98/79/EC (IVDD).

Please note that the new forms will become manda­to­ry as of Jan­u­ary 2020. Against this back­ground, the Euro­pean Com­mis­sion has also pro­vid­ed a sup­ple­men­tary guid­ance doc­u­ment for MEDDEV 2.12-1, rev. 8 on vigilance.

Should you require the afore­men­tioned doc­u­ments or fur­ther details, please get in touch with us.