{"id":2966,"date":"2024-01-11T11:19:23","date_gmt":"2024-01-11T11:19:23","guid":{"rendered":"https:\/\/artificialintelligenceact.eu\/article\/11\/"},"modified":"2024-08-08T12:36:02","modified_gmt":"2024-08-08T12:36:02","slug":"11","status":"publish","type":"article","link":"https:\/\/artificialintelligenceact.eu\/article\/11\/","title":{"rendered":"Article 11: Technical Documentation"},"content":{"rendered":"

1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date. The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV<\/a>. SMEs, including start-ups, may provide the elements of the technical documentation specified in Annex IV<\/a> in a simplified manner. To that end, the Commission shall establish a simplified technical documentation form targeted at the needs of small and microenterprises. Where an SME, including a start-up, opts to provide the information required in Annex IV<\/a> in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.<\/p>\n

2. Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section A of Annex I<\/a> is placed on the market or put into service, a single set of technical documentation shall be drawn up containing all the information set out in paragraph 1, as well as the information required under those legal acts.<\/p>\n

3. The Commission is empowered to adopt delegated acts in accordance with Article 97<\/a> in order to amend Annex IV<\/a>, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this Section.<\/p>\n","protected":false},"template":"","class_list":["post-2966","article","type-article","status-publish","hentry"],"meta_box":{"date_of_eif":"2 August 2026","eif_according_to":"Article 113","eif_inherit_from":"","item_summary":"

This EU law states that before a high-risk AI system is launched, detailed technical documentation must be prepared and kept updated. This documentation should prove that the AI system meets the law's requirements and provide clear information for authorities to check compliance. It should include certain key elements. Small businesses, including start-ups, can provide this information in a simpler way. The EU will create a simplified form for this purpose. If a high-risk AI system is related to a product covered by other EU laws, one set of documentation should include all necessary information. The EU can update these requirements as technology advances.<\/p>\n","item_notes":"","item_order":"11","chapter-article_from":["3447"],"article-recital_to":["2628","2633"],"title-article_from":[]},"_links":{"self":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/article\/2966","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/article"}],"about":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/types\/article"}],"version-history":[{"count":2,"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/article\/2966\/revisions"}],"predecessor-version":[{"id":5222,"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/article\/2966\/revisions\/5222"}],"wp:attachment":[{"href":"https:\/\/artificialintelligenceact.eu\/wp-json\/wp\/v2\/media?parent=2966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}