It is com­mon­ly known that COVID-19 IVD tests may be CE marked under annex III of the IVD Direc­tive with­out the involve­ment of a Noti­fied Body.

To nonethe­less increase super­vi­sion, com­pe­tent author­i­ties in Ger­many have imple­ment­ed rou­tines with addi­tion­al review mechanisms. 

In addi­tion to the guid­ance on per­for­mance eval­u­a­tions for COVID-19 IVD that has been pub­lished ear­li­er this year (see rec­om­mend­ed arti­cles below), the Ger­man Fed­er­al Insti­tute of Vac­cines and Bio­med­i­cines has issued their per­spec­tive on per­for­mance cri­te­ria test sys­tems relat­ed to rapid SARS CoV 2 anti­gen tests should ful­fill (link fur­ther down).

It is high­ly rec­om­mend­able to use these ref­er­ence val­ues when review­ing the cor­re­spond­ing tech­ni­cal doc­u­men­ta­tion to make sure that reim­burse­ment in Ger­many is pro­vid­ed for.

Source: BfArM