Besides vaccination, one of the most important measures to counter the COVID-19 pandemic is to test people for the virus and order them to quarantine if necessary. While tests for specific diseases such as COVID-19 may normally be handled only by medical professionals, the legislature has amended the Ordinance Regulating the Dispensing of Medical Products to enable such tests to be dispensed by laypeople as well.
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 legislature recently acknowledged that digital innovation plays an important role in the health sector. The Act on Digital Supply (DVG) established numerous essential measures to facilitate the inclusion of digital innovation to standard care under the German statutory social health security system. One of the most important innovations that the DVG introduced is insured persons' entitlement to medical devices based on software and other digital technologies with a medical purpose (digital health apps).
A recent Munich Higher District Court case examined whether the advertising of digital medical consultations by Swiss-based doctors is admissible under the Law on Advertising in the Health Sector. The decision underlines the importance of a detailed case-by-case examination of advertising (for remote treatment). Such an examination must cover not only competition law aspects in general, but also medical aspects in particular, such as generally accepted professional standards.
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.