What Liability with the Internet of Things? Insights from the European Case-Law of the PIP Affair

Abstract

The purpose of this article is to explain why it is relevant to connect the European case-law on the Medical Devices Directive (MDD), by focussing on the defective breasts prostheses saga, to the future regulation of liability for healthcare IoT objects. I believe that by examining the recent case-law dealing with shortcomings in the regulation of medical devices, it will be possible to build a future liability scheme for defective IoT objects with medical functions. The article discusses how the new Medical Devices Regulation (MDR) is different from the previous MDD and whether it is likely to influence liability schemes for healthcare IoT objects. In conclusion, I argue that, however imperfect, the MDR could support the application of national liability systems in order to provide more effective and more protective liability schemes for IoT objects with medical functions.