IVD devices that can be used by laypeople in the household environment according to the intended purpose specified by the manufacturer (devices for personal use), undergo a conformity assessment procedure with the participation of notified bodies, which, among other things, monitor compliance with the common technical specifications. These prescribe additional lay studies for the purposes of rapid tests, e.g. for HIV or SARS-CoV-2. Why?
Tests for self-use must be produced in such a way that the device (including instructions for use, labeling, etc.) is sufficiently usable in terms of performance and safety for self-use by a layperson, and the quality of the results can be ensured under these conditions of use. This encompasses the entire application of the test and also includes the consideration of suitable and reliable sampling and result presentation and is checked as part of a layman (=self-test) study.
Due to the current pandemic situation and the need for broad and rapid testing amongst many people, the commercialization of rapid antigen tests for direct pathogen detection of the SARS-CoV2 coronavirus for self-testing (self-tests), even without a CE mark, is currently under restricted authorization by the BfArM in accordance with Section 11 (1) of the MPG (Medical Devices Act).
These non-CE-certified self-tests must, however, meet certain minimum criteria for market access, whereby, among other things, a check for user-friendliness in the form of a lay study is required.
Biomex has already supported several manufacturers in the validation of their SARS-CoV-2 antigen rapid tests and has the required know-how and the corresponding infrastructure to implement layman studies in a timely manner. Contact us!