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ObligationUpcomingv1.0.0

Article 16: the twelve duties of a provider of a high-risk AI system

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.

The official source remains authoritative. This is general information about obligations and not legal advice. See this object on the map

Address and citation

This object has an address of its own that is never renamed or reused. Store the identifier in your own file, not the title or the link.

Identifier
praxikon:eu:ai-act:obligation:article-16-provider-obligations
Payload hash (sha256)
69744054b2105841ae2447d2d83216af48b1ea7983b7bbeeb9330a5d40469275

Citation line

Praxikon, "Article 16: the twelve duties of a provider of a high-risk AI system", praxikon:eu:ai-act:obligation:article-16-provider-obligations@1.0.0, dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0), effective_at 2026-08-08T00:00:00.000Z, known_at 2026-08-14T00:00:00.000Z, sha256 69744054b2105841ae2447d2d83216af48b1ea7983b7bbeeb9330a5d40469275
Version
1.0.0
Legal time (effective_at)
8 August 2026
Knowledge time (known_at)
8 August 2026
Closed on
Not closed
Application date
2 December 2027
Topics
high-risk-requirements

Review status: Placed against the official source (8 August 2026). Next check due by 4 February 2027. The check date is the knowledge date of this version; no later recheck has been recorded.

Who must act and who is affected

On an obligation the addressee is recorded separately from the party that is merely affected. That difference decides who a supervisory authority addresses and who has work to do without the duty resting on them.

Duty holder

Affected actor

Not recorded on this object.

Oversight

Not recorded on this object.

Evidence owner

What this object links to

Every relation appears below as a path: from the source with its locator, through the conditions and exceptions of the object carrying the relation, to the consequence. A locator belongs to a statement in the data and not to a relation, so the source is the source anchor of the carrying object.

Who carries the duty

1 of 1 shown

The duty rests on this role. A supervisory authority addresses this role when it is not met.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 16(a)-(l)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies 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.
    • ExceptionA 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).

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

Who owns the evidence

1 of 1 shown

This duty holder creates, maintains and can produce the evidence.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 16(a)-(l)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies 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.
    • ExceptionA 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).

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What has to be done

1 of 1 shown

This is what concretely has to be done under the obligation.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 16(a)-(l)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies 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.
    • ExceptionA 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).

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What has to be recorded

1 of 1 shown

This is what has to be in the file to show that the action was carried out.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 16(a)-(l)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies 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.
    • ExceptionA 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).

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What keeps it in place

1 of 1 shown

This is what keeps compliance in place over time, periodic or event-driven.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 16(a)-(l)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies 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.
    • ExceptionA 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).

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

Public tools

1 of 1 shown

This is the public route a reader can actually use.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 16(a)-(l)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies 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.
    • ExceptionA 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).

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What points at this object

Objects hanging off this obligation

4 of 4 shown

The object belongs to this obligation. The source line it hangs off sits there.

  1. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 16(a)-(l)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allTo be carried out as soon as it is established that you are the provider of a system classified as high-risk under Article 6, well before the intended date of placing on the market.

    Relation recorded on: Assign an internal owner and a date to each point of Article 16

    Consequence

  2. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 16(a)-(l)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies at every first supply to the market and again after a substantial modification within the meaning of Article 3(23), that is, a change after placing on the market or putting into service which was not foreseen in the initial conformity assessment and which affects compliance with Chapter III, Section 2, or results in a modification of the assessed intended purpose. Article 43(4) requires a new conformity assessment procedure in that case.

    Relation recorded on: Release gate before placing on the market

    Consequence

  3. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 16(a)-(l)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allTo be maintained per individual high-risk AI system, not per product line or per supplier.

    Relation recorded on: Provider dossier per high-risk AI system

    Consequence

  4. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 16(a)-(l)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Full text of Article 16

    Consequence

What this object states

Official fact

Attributable to a named primary source, with a locator. Where they differ, the official source prevails.

  • 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)).

Our interpretation

Our own reading. It can change without the law changing, and it is not the position of a supervisory authority.

  • 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.

Recommended step

A practical step we consider appropriate. Not an obligation following from the Regulation.

  • 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.

When this applies

  1. 1Applies 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.

When this does not apply

  • 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).

Referring to this object

Citation block

Copy this reference into your advice, article or file. The identifier, the version and the hash keep the statement findable later, even once the dataset has moved on.

Reference

Praxikon, "Article 16: the twelve duties of a provider of a high-risk AI system",
praxikon:eu:ai-act:obligation:article-16-provider-obligations@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0),
effective_at 2026-08-08T00:00:00.000Z, known_at 2026-08-08T00:00:00.000Z,
sha256 69744054b2105841ae2447d2d83216af48b1ea7983b7bbeeb9330a5d40469275,
https://www.praxikon.com/en/verkenner/obligation/article-16-provider-obligations
(https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-16-provider-obligations&effective_at=2026-08-08&known_at=2026-08-08&lang=en, accessed 2026-08-23)

Short form

praxikon:eu:ai-act:obligation:article-16-provider-obligations@1.0.0 (sha256 69744054)

BibTeX

@misc{praxikon-eu-ai-act-obligation-article-16-provider-obligations-1-0-0,
  author       = {{Praxikon}},
  title        = {Article 16: the twelve duties of a provider of a high-risk AI system},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:obligation:article-16-provider-obligations},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.1.0, schema 1.4.0},
  note         = {effective_at 2026-08-08T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 69744054b2105841ae2447d2d83216af48b1ea7983b7bbeeb9330a5d40469275},
  url          = {https://www.praxikon.com/en/verkenner/obligation/article-16-provider-obligations},
  urldate      = {2026-08-23},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:obligation:article-16-provider-obligations@1.0.0",
    "type": "dataset",
    "title": "Article 16: the twelve duties of a provider of a high-risk AI system",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:obligation:article-16-provider-obligations",
    "URL": "https://www.praxikon.com/en/verkenner/obligation/article-16-provider-obligations",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          8
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
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      ]
    },
    "note": "dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0; schema 1.4.0; effective_at 2026-08-08T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 69744054b2105841ae2447d2d83216af48b1ea7983b7bbeeb9330a5d40469275; retrieved_from https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-16-provider-obligations&effective_at=2026-08-08&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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