Covid-19 Self-tests for laymen in Poland and Germany – Q&A

Self-testing has become popular in the last months due to the Covid-19 pandemic. Self-tests for laymen are intended to be used by everyone, also those without any medical education, in order to detect an infection with the SARS-CoV-2 virus. However, not many know that such tests constitute a very specific kind of products and as such are subject to respective legal requirements.   In this podcast, Magdalena Kotyrba-Hagenmaier (Principal Associate, IP, Health and Life Sciences, Germany) and Martyna Gałdecka (Associate, Commercial, Poland) discuss Covid-19 Self-tests for laymen in Poland and Germany. They will cover: Are self-tests considered medical devices and need to be registered? Is the emergency approval procedure implemented in both countries? Do such tests need to be specifically labelled?