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Article 46: Derogation from conformity assessment procedure
Article 46 allows market surveillance authorities in exceptional cases to authorise placing specific high-risk AI systems on the market without full conformity assessment, if public safety or health protection requires it.
Zahed Ashkara, AI and privacy legal adviserobligations checked against the source on
Praxikon tracks Article 46 (Derogation from conformity assessment procedure) under the EU AI Act, citing the source for every statement.
EU Official:
Title III: High-Risk AI Systems
Official text
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Source: EUR-Lex, Regulation (EU) 2024/1689. Text reproduced verbatim.
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Frequently asked questions
When does a derogation from conformity assessment apply under Article 46?+
Article 46 allows market surveillance authorities in exceptional cases to authorise placing specific high-risk AI systems on the market without full conformity assessment, if public safety or health protection requires it.
What documentation does Article 46 of the AI Act require?+
Article 46 of the AI Act requires that relevant documentation is maintained as part of the compliance process. This may include technical documentation, instructions for use, logs or declarations of conformity, depending on the classification of the AI system.
How do I document compliance with Article 46 of the AI Act?+
You document compliance with Article 46 of the AI Act by establishing a risk management system, maintaining technical documentation, and conducting internal audits. Keep all relevant documents for the period prescribed by the AI Act.