Presumption of Conformity

Presumption of Conformity is a fundamental EU legal concept that applies to the AI Act: when an AI system conforms to harmonised standards (or parts thereof), it is presumed to comply with the AI Act requirements covered by those standards (Article 40).

How It Works:

• Harmonised Standards: The EU Commission requests European standardisation organisations (CEN, CENELEC, ETSI) to develop harmonised standards for AI
• Publication in OJ: References to these standards are published in the Official Journal of the European Union
• Automatic Presumption: Once published, conformity with these standards creates a legal presumption of compliance
• Rebuttable: The presumption can be challenged by market surveillance authorities if evidence shows non-compliance

Benefits for Providers:

• Legal Certainty: Clear pathway to demonstrating compliance
• Simplified Assessment: No need to prove compliance with each individual requirement if standards are followed
• Market Access: Facilitates placing AI systems on the EU market
• Reduced Burden: Standardized approach reduces compliance complexity

Current Status:

• AI Act harmonised standards are under development by CEN-CENELEC Joint Technical Committee 21 (JTC 21)
• Expected to cover areas like: risk management, data governance, transparency, human oversight, accuracy, robustness, cybersecurity
• Until standards are published, providers must demonstrate compliance through other means

Common Specifications: If harmonised standards don't exist or are insufficient, the Commission may adopt common specifications through implementing acts, which also provide presumption of conformity when followed (Article 41).