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.
EU Clarifies AI System Definition, Including Specific Medical Technologies
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.
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