Authorisations for rapid SARS-CoV-2 tests for laypersons in Germany

The SARS-CoV-2 pandemic is spreading widely and constantly. One of the most important measures in the fight against the virus, besides vaccination, is to test people for the virus and to order quarantine if necessary.

Under German law, in principle, tests for diseases such as Covid-19 may only be handled by medical professionals under the German Ordinance on Handing over of Medical Devices (MPAV). The reason for this was inter alia that the German legislator wanted to ensure proper traceability of infections, since professional users are required to inform the authorities upon positive tests. However, considering the need for such tests for laypersons (eg when visiting family or friends), the German legislator has amended the MPAV allowing dispensing such tests to laypersons, as well.

Given that SARS-CoV-2 tests for laypersons represent in vitro diagnostics, ie medical devices, such tests are regulated by the German Medical Devices Act (MPG) implementing the European directive 98/79/EC on in vitro diagnostics.

Following the MPG, SARS-CoV-2 tests for laypersons generally have to undergo a conformity assessment procedure involving a notified body. However, since such procedures take significant time and the amendment of the MPAV is quite new, it is not surprising that many manufacturers have not completed them yet.

The MPG provides assistance in such situations: under specific conditions of an exceptional authorisation, medical devices may be placed on the market, even if a required conformity assessment procedure has not yet been completed. The main prerequisite is that the use of such products, even before a conformity assessment has been conducted is in the interest of the protection of health.

Sec. 11 para. 1 MPG reads as follows:
“By way of derogation from the provisions contained in Sec. 6 para. 1 and 2 (conformity assessment procedure and subsequent CE marking), the competent higher federal authority may authorise for a limited period of time, on duly justified application, the first placing on the market or putting into service in Germany, of individual medical devices for which the procedures according to the ordinance pursuant to Sec. 37 para. 1 (Ordinance on Medical Devices and Conformity Assessments) have not been carried out, provided their use is in the interest of the protection of health.”

The German Federal Institute for Medicinal Products and Medical Devices (BfArM) being competent authority in the meaning of Sec. 11 para. 1 MPG it has published guidance on exceptional authorisations for SARS-CoV-2 tests for laypersons.

To obtain an exceptional authorisation, the manufacturer has to submit an application in writing. The manufacturer has inter alia to demonstrate (1) the request for involvement of a notified body in a conformity assessment procedure, (2) a positive evaluation of the respective tests (for professional use) by the Paul-Ehrlich-Institute, (3) meeting the essential requirements given by the Paul-Ehrlich-Institute and by Annex I no. 7 of the European directive 98/79/EC and (4) a positive outcome of an usability study according to IEC 62366. This is particularly important in order to prove that use by laypersons leads to reliable results.

Exceptional authorisations will be valid for a limited period of time, eg three months, and can be prolonged upon further application. The BfArM undertakes a strict examination if the conditions for an exceptional authorisation are met. However, by today, a number of tests have passed this strict examination and can be used by laypersons in circumstances where it is important to have a quick answer on the probability of infectiousness and where a test conducted by healthcare professionals is not at hand.