Everyday masks are not medical devices

The Higher Regional Court of Hamm has ruled that simple fabric masks or a mouth-nose cover are not a “medical device” within the meaning of the Medical Devices Act (MPG). The fact that such masks contribute to the containment of viral infections, in particular the SARS-CoV-2 coronavirus, is not sufficient on its own. The same applies to water and soap, which also reduce the risk of infection when washing hands regularly, without having to be classified as medical devices. It is therefore also not misleading in accordance with Sections 5, 5a UWG if there is no explicit clarification that the products are not medical devices. Instructions for use in accordance with § 3 Para. 4 ProdSG is also not required for the sale of masks for non-medical purposes (OLG Hamm, decision of 15.12.2020, ref.: 4 W 116/20).