The Hamm Higher Regional Court recently found that fabric masks do not constitute medical devices, regardless of whether they are displayed alongside medical face masks or whether the public attributes to them a protective effect against COVID-19. The decision shows the importance of labelling, presentation and the placement of products on the market and highlights the pitfalls that lurk in this area.
The Frankfurt am Main District Court recently examined whether a Federal Institute for Drugs and Medical Devices notification can establish whether a preparation is a medicinal product subject to authorisation. In principle, the courts are bound by the institute's assessment unless the notification is null and void. However, if a notification is redacted in such a way that its constituent elements are unknown, the court must decide whether the preparation is a functional medicinal product or a presentation drug.