The abbreviation BfArM stands for the Federal Institute for Drugs and Medical Devices in Germany. The BfArM provides a list of all tests which, according to the manufacturer, fulfil the minimum criteria defined by the Paul Ehrlich Institute in consultation with the RKI. This list only contains antigen rapid tests which have been notified to the BfArM by the manufacturer or distributor.
The antigen rapid tests on the BfArM list are reimbursable according to the Coronavirus-Testverordnung-TestV.
With regard to the self-tests, the BfArM issues the special approvals for home testing without CE marking for a limited period of time according to § 11 para. 1 MPG (Medical Devices Act) in Germany. For the special approval of the antigen rapid tests for home use, the BfArM not only includes the evaluation of the Paul Ehrlich Institute, but also whether sampling and testing are comprehensible and easy to perform for laypersons according to the instructions for use.
Source: https://www.pei.de/DE/newsroom/dossier/coronavirus/coronavirus-inhalt.html;jsessionid=09B536A7388CE2341E5768C21C36E201.intranet231?nn=169730&cms_pos=3
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