New EU product liability rules extend to innovative medical devices and AI
The new EU product liability rules also affect innovative medical devices and claims relating to the internal workings of AI systems (recital 48). The authors expect few such lawsuits in practice.
Who is affected and how
- medtech company
- Must reassess liability exposure and the provability of its documentation.
- health IT
- Logging and explainability of AI system operation gain legal significance.
Sources
- Beyond physical damage: The new scope of product liability in the EUhlc.com · Sep 28, 2026
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