Die Zweckbestimmung von Medizinprodukten und ihre Auswirkung auf Haftung und Verantwortlichkeit von Anwender und Betreiber

It is common practice for users and operators of medical devices to disregard the intended purpose of the manufacturer by reprocessing products placed on the market as single-use devices or by combining medical devices from different manufacturers. In contrast to ‘Off-label use’ under pharmaceutical law, the consequences of such use in the context of the law on medical devices have so far only been superficially clarified.
This work examines the interconnected complex issues pertaining to medical device law, medical liability law and product liability law in detail, also against the background of the new EU regulation 2017/745 on medical devices, and finds results that are usable in practice. In particular, it identifies the central importance of the intended purpose of medical devices and its as yet unclear definition.