AI Summit_Sept. 13 2024

6. Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance authority of the Member State concerned. 7. ▌ For high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply .

Article 47 EU declaration of conformity

1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI system, and keep it at the disposal of the national competent authorities for 10 years after the high-risk AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the high-risk AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be submitted to the relevant national competent authorities upon request. 2. The EU declaration of conformity shall state that the high-risk AI system concerned meets the requirements set out in Section 2. The EU declaration of conformity shall contain the information set out in Annex V, and shall be translated into a language that can be easily understood by the national competent authorities of the Member States in which the high-risk AI system is placed on the market or made available.

AI Roundtable Page 471