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EvidenceEditorialv1.0.0

File accompanying a request to derogate from the conformity assessment

Per request: which system and which version, which exceptional reason was invoked and on which facts, to which market surveillance authority and on what date the request was made, what the status of the conformity assessment was, which end date was agreed, when the notification of paragraph 3 was made, and what the outcome was.

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:evidence:article-46-derogation-request-file
Payload hash (sha256)
7a60ee7f6aab31c0e55ae153388ff5bed3d896afd90ed226eebffc7bdd6506e9

Citation line

Praxikon, "File accompanying a request to derogate from the conformity assessment", praxikon:eu:ai-act:evidence:article-46-derogation-request-file@1.0.0, dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0 (schema 1.5.0), effective_at 2026-08-08T00:00:00.000Z, known_at 2026-09-06T00:00:00.000Z, sha256 7a60ee7f6aab31c0e55ae153388ff5bed3d896afd90ed226eebffc7bdd6506e9
Version
1.0.0
Legal time (effective_at)
2 August 2026
Knowledge time (known_at)
6 September 2026
Closed on
Not closed
Topics
conformity, enforcement, evidence

Review status: Editorially reviewed (6 September 2026). Next check due by 5 March 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 46(1)-(2)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Consequence

What this object is about

3 of 3 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 46(1)-(2)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Consequence

What points at this object

Where this evidence comes from

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 46(1)-(2)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(3)-(4)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 46(5)-(7)

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

      Open official source

    Via

    • Condition | any ofThe authorisation may be granted only for exceptional reasons of public security or the protection of life and health of persons, environmental protection or the protection of key industrial and infrastructural assets. That list is the entire basis: a commercial interest, a delivery deadline or a tender date is not in it.
    • Condition | allA duly justified request is required, the authorisation comes from a market surveillance authority, it concerns specific high-risk AI systems, and it operates solely within the territory of the Member State concerned. It is moreover for a limited period while the necessary conformity assessment procedures are being carried out, and the completion of those procedures shall be undertaken without undue delay.
    • Condition | allThe authorisation is issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The derogation therefore concerns the procedure of Article 43 and not the substantive requirements of Articles 8 to 15: those must be met before the authorisation exists.
    • ExceptionParagraph 2 removes the prior authorisation in a duly justified situation of urgency for exceptional reasons of public security or in the case of a specific, substantial and imminent threat to the life or physical safety of natural persons. Only law-enforcement authorities and civil protection authorities may rely on it, and only for putting into service, provided that such authorisation is requested during or after the use without undue delay.
    • ExceptionParagraph 7 excludes this Article for high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I. There, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply. For a regulated product, Article 46 is therefore not a route.
    • ExceptionThe notification duty in paragraph 3 towards the Commission and the other Member States shall not cover sensitive operational data in relation to the activities of law-enforcement authorities. The authorisation itself stands; the flow of data around it is limited.

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

    Relation recorded on: Article 46: derogation from conformity assessment procedure

    Consequence

When this applies

No condition recorded on this object.

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, "File accompanying a request to derogate from the conformity assessment",
praxikon:eu:ai-act:evidence:article-46-derogation-request-file@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0 (schema 1.5.0),
effective_at 2026-08-02T00:00:00.000Z, known_at 2026-09-06T00:00:00.000Z,
sha256 7a60ee7f6aab31c0e55ae153388ff5bed3d896afd90ed226eebffc7bdd6506e9,
https://www.praxikon.com/en/verkenner/evidence/article-46-derogation-request-file
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aevidence%3Aarticle-46-derogation-request-file&effective_at=2026-08-02&known_at=2026-09-06&lang=en, accessed 2026-09-21)

Short form

praxikon:eu:ai-act:evidence:article-46-derogation-request-file@1.0.0 (sha256 7a60ee7f)

BibTeX

@misc{praxikon-eu-ai-act-evidence-article-46-derogation-request-file-1-0-0,
  author       = {{Praxikon}},
  title        = {File accompanying a request to derogate from the conformity assessment},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:evidence:article-46-derogation-request-file},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.2.0, schema 1.5.0},
  note         = {effective_at 2026-08-02T00:00:00.000Z; known_at 2026-09-06T00:00:00.000Z; sha256 7a60ee7f6aab31c0e55ae153388ff5bed3d896afd90ed226eebffc7bdd6506e9},
  url          = {https://www.praxikon.com/en/verkenner/evidence/article-46-derogation-request-file},
  urldate      = {2026-09-21},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:evidence:article-46-derogation-request-file@1.0.0",
    "type": "dataset",
    "title": "File accompanying a request to derogate from the conformity assessment",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:evidence:article-46-derogation-request-file",
    "URL": "https://www.praxikon.com/en/verkenner/evidence/article-46-derogation-request-file",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          9,
          6
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          9,
          21
        ]
      ]
    },
    "note": "dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0; schema 1.5.0; effective_at 2026-08-02T00:00:00.000Z; known_at 2026-09-06T00:00:00.000Z; sha256 7a60ee7f6aab31c0e55ae153388ff5bed3d896afd90ed226eebffc7bdd6506e9; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aevidence%3Aarticle-46-derogation-request-file&effective_at=2026-08-02&known_at=2026-09-06&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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