Approval for COVID-19 rapid anti­gen tests intend­ed for self-test­ing by lay persons

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:

• Descrip­tion of the product
• Proof of appli­ca­tion for a reg­u­lar con­for­mi­ty assess­ment pro­ce­dure with a Euro­pean noti­fied body – if no noti­fied body accepts the appli­ca­tion, a copy of the rejec­tion from at least 2 noti­fied bodies
• CE mark­ing of the prod­uct for pro­fes­sion­al users
• pos­i­tive eval­u­a­tion of the prod­uct for pro­fes­sion­al users by the Paul-Ehrlich-Insti­tute (PEI)
• ful­fill­ment of the cur­rent min­i­mum cri­te­ria of the Paul-Ehrlich-Insti­tute (PEI)
• Instruc­tions for use in Ger­man lan­guage intend­ed for self-administration
• repack­ag­ing of the prod­uct for self-testing
• usabil­i­ty study accord­ing to IEC 62366
• proof of com­pli­ance with the essen­tial require­ments spec­i­fied in Annex I No. 7 of Direc­tive 98/79/EC specif­i­cal­ly for use by lay persons
• up-to-date risk analy­sis, please high­light the risks result­ing from the self-test­ing by layper­son in the sub­mit­ted copy.

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

• Euro­pean Com­mis­sion pub­lish­es Q&A guid­ance on COVID-19 tests
• Defined per­for­mance cri­te­ria for rapid SARS-CoV-2 anti­gen tests
• COVID-19 In Vit­ro Diag­nos­tic Devices and Test Meth­ods Data­base available
• Euro­pean Com­mis­sion gives details of how to pre­vent COVID-19 test failures