Ger­many has updat­ed its leg­is­la­tion and allows for spe­cial admis­sions of anti­gen tests for self-admin­is­tra­tion by layper­sons (self-tests) for the detec­tion of SARS-CoV-2. The com­mon con­for­mi­ty assess­ment pro­ce­dure for self-test devices involves a Noti­fied Body before they can be placed on the mar­ket. An exemp­tion from this process or the spe­cial admis­sion respec­tive­ly is thus bound to cer­tain conditions. 

The Ger­man Fed­er­al Insti­tute for Drugs and Med­ical Devices (BfArM) has pub­lished clar­i­fi­ca­tion on the cor­re­spond­ing require­ments on its website: 

In case of appli­ca­tion for spe­cial approval of an in vit­ro diag­nos­tic test for self-test­ing by layper­sons, e.g., for SARS-CoV-2 coro­na virus, the appli­cant shall specif­i­cal­ly sub­mit or pro­vide evi­dence of the following:

The BfArM reserves the right to request fur­ther doc­u­ments and infor­ma­tion in the course of the pro­ce­dure. Full infor­ma­tion can be accessed here.

Source: BfArM

To receive fur­ther infor­ma­tion on this sub­ject, please notice the fol­low­ing arti­cles and con­tent on our website