Article 16

Obligations of providers of high-risk AI systems

Providers of high-risk AI systems shall:

(a)

ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;

(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;

(c)

have a quality management system in place which complies with Article 17;

(d)

keep the documentation referred to in Article 18;

(e)

when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;

(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;

(g)

draw up an EU declaration of conformity in accordance with Article 47;

(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;

(i)

comply with the registration obligations referred to in Article 49(1);

(j)

take the necessary corrective actions and provide information as required in Article 20;

(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;

(l)

ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.

Frequently Asked Questions

Providers must ensure their high-risk AI systems meet specific rules outlined in the AI Act, including safety checks, quality management, record-keeping and undergoing formal conformity reviews; they also have to clearly label their products, demonstrate compliance to authorities when asked, and meet accessibility standards as defined by EU directives.
Providers demonstrate compliance by performing official assessments and preparing an EU declaration confirming conformity; they must also attach a CE marking on the AI system or its packaging to show it meets all required standards set by the AI Act.
Providers must maintain detailed technical documentation and store logs that the AI system automatically creates during operations; these records help authorities monitor the safety and compliance of the technology and ensure providers continually manage quality and address issues promptly.
Yes, providers must ensure their high-risk AI systems meet accessibility requirements according to EU rules, ensuring the AI systems can be used equally by all people, including those with disabilities, following directives intended to promote digital accessibility and inclusive design practices.

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