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EU Clarifies AI System Definition, Including Specific Medical Technologies

 
• By Amanda Maxwell

The new definition of what is considered an ‘AI system’ in the context of the EU’s AI Act is helpful, but there is no automatic determination for medtech, and gray areas persist.

close up of a dictionary on the word "definition"
(Shutterstock)

On 6 February, the European Commission released guidelines clarifying the definition of an AI system under the AI Act (AIA). These guidelines, effective retroactively from 2 February 2024, are crucial for understanding the scope of the AI Act, including its now enforced prohibitions on certain AI practices.

The commission’s 13-page document, on the definition of an AI system, aims to assist providers and other relevant persons in determining whether a software system constitutes an AI system.

The Core Definition Of An AI System

Article 3 (1) of the AI Act defines an AI system as follows:

“AI system’ means a machine-based system that is designed to...

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