The Ger­man Fed­er­al Insti­tute for Drugs and Med­ical Devices (BfArM) has spec­i­fied on its web­site the pro­vi­sions for this spe­cial route, which fol­lows Rec­om­men­da­tion (EU) 2020/403 from March 13. The arti­cle is only avail­able in Ger­man – should you require fur­ther details, please don’t hes­i­tate to get in touch.

In a recent arti­cle, we have indi­cat­ed to a spe­cial autho­riza­tion of cer­tain med­ical devices and PPE urgent­ly required in the cur­rent COVID-19 cri­sis, e.g. face masks and sur­gi­cal masks. 

Face masks accord­ing to the Med­ical Devices Direc­tive (MDD)

Man­u­fac­tur­ers may fol­low the gen­er­al test prin­ci­ples accord­ing to EN 14683:2019 and apply for the spe­cial autho­riza­tion by pro­vid­ing the cor­re­spond­ing reports. It is impor­tant to men­tion that this pro­ce­dure does not per­mit man­u­fac­tur­ers to affix the CE mark on their prod­ucts or sell their devices on the mar­ket claim­ing com­pli­ance to the PPE Reg­u­la­tion (EU) 2016/425.

Face masks accord­ing to the PPE Regulation

Prod­ucts of this type – typ­i­cal­ly fil­ter­ing face piece (FFP) masks – would nor­mal­ly require cer­ti­fi­ca­tion by a Noti­fied Body before plac­ing them on the mar­ket. Rec­om­men­da­tion (EU). If no cer­tifi­cate is avail­able or mar­ketabil­i­ty in the USA, Cana­da, Aus­tralia or Japan can­not be proven, man­u­fac­tur­ers may fol­low test prin­ci­ples accord­ing to EN 149:2001 and apply for a spe­cial autho­riza­tion by pro­vid­ing the cor­re­spond­ing test reports. 

Noti­fied Bod­ies, for exam­ple bsi, have incor­po­rat­ed the new pro­vi­sions as per Rec­om­men­da­tion (EU) 2020/403 in their busi­ness prac­tice and offer var­i­ous routes for man­u­fac­tur­ers to com­ply with the require­ments. The cor­re­spond­ing arti­cle is avail­able in Ger­man – should you require addi­tion­al details, please let us know.

Sources: BfArM and bsi

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website