EU court ruling clarifies medical device definition for software and AI
The Court of Justice of the EU has clarified that the medical device test considers both objective function and intended purpose. The ruling gives guidance on classifying software and AI tools.
Who is affected and how
- medtech company
- Intended-purpose wording and function should be reassessed, as they decide whether AI software qualifies as a device.
- health IT
- Wellness and decision-support software warrants legal review.
Sources
- Is my product a medical device? EU Court judgment clarifies that the test includes objective function and intended purpose, and provides guidance relevant to software and AI-enabled toolslexblog.com · Aug 31, 2026
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