Article 16 — Obligations of providers of high-risk AI systems
Digital & dataLevel 1RegulationAI ActApplies from 2 Dec 2027Official source
Providers of high-risk AI systems shall:
16(a)
(a)ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
Copy link16(b)
(b)indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;
Copy link16(e)
(e)when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
Copy link16(f)
(f)ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;
Copy link16(h)
(h)affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;
Copy link16(j)
(j)take the necessary corrective actions and provide information as required in Article 20;
Copy link16(k)
(k)upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;
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