Liability for Medical Devices - How Clear and Harmonised Is It?

Civil liability for defective medical devices is not regulated comprehensively by European Union (EU) law. The current EU product liability rules cover a significant proportion of the cases that concern the liability of manufacturers, but the national laws of EU Member States remain relevant. The liability of parties other than manufacturers is largely left to national laws. Given the vagueness of EU law, case outcomes vary, and the law is uncertain. Economic operators need clear liability rules to gauge the risks of introducing innovations to the market. Predictable liability rules are also important for individuals and for the uptake of new technologies. At present, interpreting EU and national law can be difficult, in particular in the context of intelligent medical devices. EU legislators are eager to promote the use of beneficial artificial intelligence (AI). Accordingly, they have published two proposals that, if passed into law, would affect liability for medical devices. One of the proposals concerns a revision of the EU product liability framework. The other deals with damages liability for harm caused by AI. In this article, we address the problems of contemporary EU law and discuss developments in the Union-level regulation of liability for medical devices.