The Impact of the EU AI Act on the Development and Use of Medical Devices

Lexology November 27, 2024
Hunton Andrews Kurth LLP

On August 1, 2024, the EU Artificial Intelligence Act (AI Act) entered into force. The AI Act introduces a risk-based legal framework for AI systems that fall into four main buckets: (i) prohibited AI systems, (ii) high-risk AI systems, (iii) AI systems with transparency requirements, and (iv) general-purpose AI models.

The AI Act applies to companies that are located in the EU. In addition, the AI Act has an extraterritorial reach. It applies to so-called AI “providers,” which are companies that develop and place AI systems on the EU market (including general purpose AI models) or put AI systems into service in the EU under their own name or trademark, irrespective of the provider’s location. The AI Act further applies...

Today's Sponsors

Today's Sponsor