Intended Purpose
The use for which an AI system is intended by the provider, as specified in documentation and instructions.
Definitions (2)
The specific use(s), target population, and clinical claims for which the software is intended; this statement is the primary determinant of device classification, risk assessment, and applicable regulatory obligations.
The 'intended purpose' refers to the use for which an AI system is intended by the provider, as indicated in technical documentation, instructions for use, or promotional materials. It is a crucial factor in determining whether an AI system falls under the high-risk classification.
Related Terms
High-Risk AI System
AI systems that pose significant risks to health, safety, or fundamental rights....
Technical Documentation
Detailed records demonstrating AI system compliance with regulatory requirements....
Risk-Based Approach
Regulatory strategy that calibrates requirements based on the level of risk posed by an AI system....