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Version status: Published | Document consolidation status: No known changes
Version date: 20 November 2024 - onwards

Article 12 High-risk AI systems

1. Without prejudice to the requirements relating to accuracy and robustness set out in Article 15 of Regulation (EU) 2024/1689, products with digital elements which fall within the scope of this Regulation and which are classified as high-risk AI systems pursuant to Article 6 of that Regulation shall be deemed to comply with the cybersecurity requirements set out in Article 15 of that Regulation where:

(a) those products fulfil the essential cybersecurity requirements set out in Part I of Annex I;

(b) the processes put in place by the manufacturer comply with the essential cybersecurity requirements set out in Part II of Annex I; and

(c) the achievement of the level of cybersecurity protection required under Article 15 of Regulation (EU) 2024/1689 is demonstrated in the EU declaration of conformity issued under this Regulation.