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Mandatory requirements:
- providers of high-risk AI systems must comply with mandatory requirements and undergo ex-ante conformity assessment
- obligations include establishing quality and risk management systems, creating detailed technical documentation, and ensuring compliance with data requirements
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Technical requirements:
- High-risk AI systems must generate operation logs for traceability and incorporate features for user oversight
- Transparency in operation is crucial for user interpretation and appropriate use
- Non-EU providers must appoint an authorized representative in the EU if directly providing AI systems to the EU market
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Art. 6 and Annex III: focus on regulating high-risk AI systems that pose potential threats to health, safety, or fundamental rights.
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AI systems that pose a significant risk to health, safety or fundamental rights, including in the following categories:
- medical devices
- vehicles
- emotion-recognition systems
- law enforcement
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Categories of High-Risk AI Systems:
- integrated into safety-critical products like medical devices, lifts and certain vehicles
- standalone systems with fundamental rights implications (such as those used in critical infrastructure management and educational assessment
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Criteria for High-Risk Determination
- Annex III lists AI systems considered high risk, with exceptions for systems performing narrow or preparatory tasks
- Providers must document assessments and notify high-risk systems to the EU database