mdi Europa has been con­tact­ed fre­quent­ly through­out the COVID-19 cri­sis regard­ing reg­u­la­to­ry require­ments for sur­gi­cal masks in Europe under Direc­tive 93/42/EEC (MDD) and Reg­u­la­tion (EU) 2017/745 (MDR) on med­ical devices.

We have pub­lished sev­er­al arti­cles on this top­ic, which we list fur­ther down. Recent­ly, the Euro­pean Com­mis­sion has pub­lished a guid­ance doc­u­ment for this prod­uct type. Man­u­fac­tur­ers engaged in this field should have a clos­er look at the doc­u­ment. You can down­load the doc­u­ment from the web­site of the Euro­pean Com­mis­sion here.

Source: Euro­pean Commission

Guard­ing the COVID-19 sub­ject, we warm­ly rec­om­mend the fol­low­ing con­tent on our website