Article 16
Obligations of Providers of High-Risk AI Systems
Article 16
Obligations of providers of high-risk AI systems
Providers of high-risk AI systems shall:
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(a)
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ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
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(b)
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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;
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(c)
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have a quality management system in place which complies with Article 17;
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(d)
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keep the documentation referred to in Article 18;
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(e)
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when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
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(f)
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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;
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(g)
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draw up an EU declaration of conformity in accordance with Article 47;
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(h)
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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;
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(i)
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comply with the registration obligations referred to in Article 49(1);
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(j)
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take the necessary corrective actions and provide information as required in Article 20;
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(k)
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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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(l)
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ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.
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Corresponding Recitals
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79
/eu-uk-ai-navigator/recital/no-79Recital 79
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80
/eu-uk-ai-navigator/recital/no-80Recital 80
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81
/eu-uk-ai-navigator/recital/no-81Recital 81
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145
/eu-uk-ai-navigator/recital/no-145Recital 145
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(79)
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It is appropriate that a specific natural or legal person, defined as the
provider, takes responsibility for the placing on the market or the putting into service of
a high-risk AI system, regardless of whether that natural or legal person is the person who
designed or developed the system.
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View Recital
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(80)
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As signatories to the United Nations Convention on the Rights of Persons with Disabilities, the Union and the Member States are legally obliged to protect persons with disabilities from discrimination and promote their equality, to ensure that persons with disabilities have access, on an equal basis with others, to information and communications technologies and systems, and to ensure respect for privacy for persons with disabilities. Given the growing importance and use of AI systems, the application of universal design principles to all new technologies and services should ensure full and equal access for everyone potentially affected by or using AI technologies, including persons with disabilities, in a way that takes full account of their inherent dignity and diversity. It is therefore essential that providers ensure full compliance with accessibility requirements, including Directive (EU) 2016/2102 of the European Parliament and of the Council (38) and Directive (EU) 2019/882. Providers should ensure compliance with these requirements by design. Therefore, the necessary measures should be integrated as much as possible into the design of the high-risk AI system.
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View Recital
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(81)
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The provider should establish a sound quality management system, ensure the accomplishment of the required conformity assessment procedure, draw up the relevant documentation and establish a robust post-market monitoring system. Providers of high-risk AI systems that are subject to obligations regarding quality management systems under relevant sectoral Union law should have the possibility to include the elements of the quality management system provided for in this Regulation as part of the existing quality management system provided for in that other sectoral Union law. The complementarity between this Regulation and existing sectoral Union law should also be taken into account in future standardisation activities or guidance adopted by the Commission. Public authorities which put into service high-risk AI systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level, as appropriate, taking into account the specificities of the sector and the competences and organisation of the public authority concerned.
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View Recital
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(145)
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In order to minimise the risks to implementation resulting from lack of
knowledge and expertise in the market as well as to facilitate compliance of providers, in
particular SMEs, including start-ups, and notified bodies with their obligations under this
Regulation, the AI-on-demand platform, the European Digital Innovation Hubs and the testing and
experimentation facilities established by the Commission and the Member States at Union or
national level should contribute to the implementation of this Regulation. Within their
respective mission and fields of competence, the AI-on-demand platform, the European Digital
Innovation Hubs and the testing and experimentation Facilities are able to provide in particular
technical and scientific support to providers and notified bodies.
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View Recital