AI Act Change & Evidence Graph
type: Dataset
description: Source-traceable links from AI Act changes and obligations to actors, actions, evidence, controls and public tools.
version: 1.0.0
language: en
creator: Praxikon
license: https://www.praxikon.com/nl/legal/terms
date modified: 2026-08-08T00:00:00.000Z
temporal coverage: 2026-08-08T00:00:00.000Z/2026-08-08T00:00:00.000Z
distribution: DataDownload
  encoding format: application/ld+json
is based on: EU Artificial Intelligence Act 2024/1689
has part: Article 16: the twelve duties of a provider of a high-risk AI system

EU Artificial Intelligence Act 2024/1689
type: LegislationObject
version: original-oj-2024-07-12
date modified: 2026-08-08T00:00:00.000Z
fingerprint basis: canonical_url|source_version|verified_at
fingerprint scope: Fingerprint of our source record (URL, edition version, verification date). Not an archive copy or content hash of the external document.
review: Review
  reviewed at: 2026-08-08T00:00:00.000Z
  reviewer: Praxikon release validation
  review method: source_link_and_rule_validation
  review status: source_checked
source locator: Article 16(a)-(l)

Article 16: the twelve duties of a provider of a high-risk AI system
type: Legislation
slug: article-16-provider-obligations
additional type: raip:obligation
description: Article 16 is the summary list of duties for providers: twelve points that route onward to the quality management system, the documentation, the logs, the conformity assessment, the EU declaration of conformity, the CE marking, the registration, corrective actions and accessibility requirements.
version: 1.0.0
effective at: 2026-08-08T00:00:00.000Z
known at: 2026-08-08T00:00:00.000Z
date modified: 2026-08-08T00:00:00.000Z
about: high-risk-requirements
applies to actor: provider
evidence requirement: article-16-provider-dossier
related control: article-16-pre-market-release-gate
related template: article-16-provider-obligations-legal-text
required action: assign-article-16-provider-duties
legal status: upcoming
deadline at: 2027-12-02T00:00:00.000Z
review: Review
  reviewed at: 2026-08-08T00:00:00.000Z
  reviewer: Praxikon release validation
  review method: source_link_and_rule_validation
  review status: source_checked
conditions of access:
  additional type: all
  description: Applies to providers of high-risk AI systems. For the standalone Annex III route (Article 6(2)) the date is 2 December 2027. For systems embedded as a safety component in products covered by the Annex I harmonisation legislation (Article 6(1)) the date is 2 August 2028.
disambiguating description:
  additional type: not
  description: A provider that considers an Annex III system not to be high-risk must document that assessment before placing it on the market and remains subject to the registration obligation of Article 49(2) (Article 6(4)). Where an AI system referred to in Annex III performs profiling of natural persons it is always considered high-risk (Article 6(3), final subparagraph).
subject of: CreativeWork
  statement kind: official_fact
  text: Article 16 requires providers of high-risk AI systems to do twelve things. They must ensure their systems comply with the requirements of Chapter III, Section 2 (point (a)); indicate on the system or, where that is not possible, on its packaging or accompanying documentation, their name, registered trade name or registered trade mark and the address at which they can be contacted (point (b)); have a quality management system in place complying with Article 17 (point (c)); keep the documentation referred to in Article 18 (point (d)); keep the automatically generated logs referred to in Article 19 when under their control (point (e)); ensure the system undergoes the conformity assessment procedure referred to in Article 43 prior to being placed on the market or put into service (point (f)); draw up an EU declaration of conformity in accordance with Article 47 (point (g)); affix the CE marking in accordance with Article 48 (point (h)); comply with the registration obligations referred to in Article 49(1) (point (i)); take the necessary corrective actions and provide the information required under Article 20 (point (j)); upon a reasoned request of a national competent authority, demonstrate conformity with the requirements of Section 2 (point (k)); and ensure the system complies with the accessibility requirements of Directives (EU) 2016/2102 and (EU) 2019/882 (point (l)).
  citation: EU Artificial Intelligence Act 2024/1689
  date modified: 2026-08-08T00:00:00.000Z
  review: Review
    reviewed at: 2026-08-08T00:00:00.000Z
    reviewer: Praxikon release validation
    review method: source_link_and_rule_validation
    review status: source_checked
subject of: CreativeWork
  statement kind: editorial_interpretation
  text: Article 16 reads like a table of contents and is therefore often planned as a single roadmap line. It is twelve separate duties with widely differing lead times: building a quality management system takes months, affixing a CE marking takes a day. The bigger trap sits in Article 25(1): anyone who puts their own brand on an existing high-risk system, substantially modifies it, or changes the intended purpose of a non-high-risk system so that it becomes high-risk counts as a provider and inherits all twelve points without ever having built anything. In the branding scenario of point (a) this applies without prejudice to contractual arrangements stipulating that the obligations are otherwise allocated, but you must have made and be able to show those arrangements in advance. In practice this catches parties that white-label AI or apply a general-purpose model to an Annex III use case.
  citation: EU Artificial Intelligence Act 2024/1689
  date modified: 2026-08-08T00:00:00.000Z
  review: Review
    reviewed at: 2026-08-08T00:00:00.000Z
    reviewer: Praxikon release validation
    review method: source_link_and_rule_validation
    review status: editorial
subject of: CreativeWork
  statement kind: recommended_action
  text: First determine whether you are a provider or whether Article 25 makes you one, then work out the twelve points as twelve separate work packages with an owner and a date. Start with points (c) and (f), because they set the lead time of the whole track.
  citation: EU Artificial Intelligence Act 2024/1689
  date modified: 2026-08-08T00:00:00.000Z
  review: Review
    reviewed at: 2026-08-08T00:00:00.000Z
    reviewer: Praxikon release validation
    review method: source_link_and_rule_validation
    review status: editorial