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ControlUpcomingv1.0.0

Release gate before placing on the market

A hard block in your release or delivery process: no delivery without a completed conformity assessment, a signed EU declaration of conformity, an affixed CE marking and a completed registration.

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:control:article-16-pre-market-release-gate
Payload hash (sha256)
00da9a8e2003346475d96e042a7b628e03b1be93c39995ec7ccb606303ea787a

Citation line

Praxikon, "Release gate before placing on the market", praxikon:eu:ai-act:control:article-16-pre-market-release-gate@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 00da9a8e2003346475d96e042a7b628e03b1be93c39995ec7ccb606303ea787a
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: Editorially reviewed (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.

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.

The obligation this hangs off

1 of 1 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 | 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.

    Consequence

What this object is about

1 of 1 shown

The object is about this role. Undifferentiated: it does not follow that the duty rests on this role.

  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 | 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.

    Consequence

What points at this object

Where this control comes from

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.

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

    Consequence

When this applies

  1. 1Applies 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.

When this does not apply

No exception recorded on this object.

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, "Release gate before placing on the market",
praxikon:eu:ai-act:control:article-16-pre-market-release-gate@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 00da9a8e2003346475d96e042a7b628e03b1be93c39995ec7ccb606303ea787a,
https://www.praxikon.com/en/verkenner/control/article-16-pre-market-release-gate
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Acontrol%3Aarticle-16-pre-market-release-gate&effective_at=2026-08-08&known_at=2026-08-08&lang=en, accessed 2026-08-23)

Short form

praxikon:eu:ai-act:control:article-16-pre-market-release-gate@1.0.0 (sha256 00da9a8e)

BibTeX

@misc{praxikon-eu-ai-act-control-article-16-pre-market-release-gate-1-0-0,
  author       = {{Praxikon}},
  title        = {Release gate before placing on the market},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:control:article-16-pre-market-release-gate},
  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 00da9a8e2003346475d96e042a7b628e03b1be93c39995ec7ccb606303ea787a},
  url          = {https://www.praxikon.com/en/verkenner/control/article-16-pre-market-release-gate},
  urldate      = {2026-08-23},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:control:article-16-pre-market-release-gate@1.0.0",
    "type": "dataset",
    "title": "Release gate before placing on the market",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:control:article-16-pre-market-release-gate",
    "URL": "https://www.praxikon.com/en/verkenner/control/article-16-pre-market-release-gate",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          8
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          8,
          23
        ]
      ]
    },
    "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 00da9a8e2003346475d96e042a7b628e03b1be93c39995ec7ccb606303ea787a; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Acontrol%3Aarticle-16-pre-market-release-gate&effective_at=2026-08-08&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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