Two recent Federal Civil Court decisions strengthen the strict understanding of Section 7(1.1) of the Act on the Advertising of Medicinal Products, under which the granting of gifts constitutes a violation of German pricing regulations. These decisions also reiterate that the unequal treatment of national pharmacies is justified due to the particularities of the German pharmacy market and the minor impact that this has on German pharmacies.
To safeguard against potential liability claims under the EU Product Liability Directive, the EU Medical Device Regulation stipulates that medical device manufacturers must have measures in place to provide sufficient financial coverage. However, as medical software can hardly be considered a 'product' under the German Act on Product Liability and the EU Product Liability Directive, it is conceivable that no liability applies under the respective provisions and, therefore, there is no need for financial coverage.
The EU Medical Device Regulation (MDR) was introduced in May 2017 and sets out the legal framework for medical devices in Germany. However, the MDR provides no definition of 'medical software' and limited rules on liability. Medical software liability under the existing regulatory framework requires that medical software be classified as a product; however, this classification is highly controversial and has been widely debated.