ControlUpcomingv1.0.0

Reassessment on a change of product or assessment route

The control that reruns the route determination as soon as the product, the AI function, the conformity assessment procedure chosen or the list in Annex I changes, instead of standing still after the first market introduction. The move of machinery to Section B on 27 July 2026 shows that the list moves too.

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:annex-i-product-route-change-gate
Payload hash (sha256): 41147ad53e75659681724c69c680f6ff2bfb2f77c57493b2b88f304dd539c613

Citation line

Praxikon, "Reassessment on a change of product or assessment route", praxikon:eu:ai-act:control:annex-i-product-route-change-gate@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 41147ad53e75659681724c69c680f6ff2bfb2f77c57493b2b88f304dd539c613

Version: 1.0.0
Legal time (effective_at): 27 July 2026
Knowledge time (known_at): 14 August 2026
Closed on: Not closed
Application date: 2 August 2028
Topics: control, high-risk

Review status: Editorially reviewed (14 August 2026). Next check due by 10 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.

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 6(1) and Annex I
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (19), replacing Article 43(3), third subparagraph
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (2)(a), replacing Article 2(2)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (41), and Article 3, point (1), amending Article 8 of Regulation (EU) 2023/1230
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 2(1), point (e), and Article 25(3)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 113, third paragraph, point (c)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (40)(b) and (c), replacing Article 113, third paragraph, point (c) and adding point (d)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (39)(a), replacing Article 111(2)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (3), inserting Article 2(13)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ObligationArticle 6(1): the product route to high risk
  praxikon:eu:ai-act:obligation:article-6-1-annex-i-product-route

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.

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 6(1) and Annex I
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (19), replacing Article 43(3), third subparagraph
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (2)(a), replacing Article 2(2)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (41), and Article 3, point (1), amending Article 8 of Regulation (EU) 2023/1230
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 2(1), point (e), and Article 25(3)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 113, third paragraph, point (c)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (40)(b) and (c), replacing Article 113, third paragraph, point (c) and adding point (d)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (39)(a), replacing Article 111(2)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (3), inserting Article 2(13)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ActorProvider of an AI system
  praxikon:eu:ai-act:actor:provider

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.

Source
Official fact on this object, with its locator.
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 6(1) and Annex I
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (19), replacing Article 43(3), third subparagraph
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (2)(a), replacing Article 2(2)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (41), and Article 3, point (1), amending Article 8 of Regulation (EU) 2023/1230
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 2(1), point (e), and Article 25(3)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 113, third paragraph, point (c)
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (40)(b) and (c), replacing Article 113, third paragraph, point (c) and adding point (d)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (39)(a), replacing Article 111(2)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
- Digital Omnibus on AI 2026/1744
  Locator: Article 1, point (3), inserting Article 2(13)
  praxikon:eu:ai-act:source:reg-eu-2026-1744
  Open official source
Via
- Condition | allThe AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I. Whether the system is placed on the market independently of that product is irrelevant.
- Condition | allThat product, or the AI system as a product itself, is required under that same harmonisation legislation to undergo a third-party conformity assessment with a view to its placing on the market or putting into service. Both conditions must be fulfilled together.
- ExceptionArticle 6(1a), inserted by Regulation (EU) 2026/1744, provides that AI systems solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control do not qualify as safety components. Paragraph 1b takes that exclusion back as soon as failure or malfunctioning would endanger health and safety.
- ExceptionArticle 6(1c), as inserted, provides that a product required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, is not considered to fulfil the condition in paragraph 1, point (b).
As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.
Relation recorded on: Article 6(1): the product route to high risk
Consequence
- ObligationArticle 6(1): the product route to high risk
  praxikon:eu:ai-act:obligation:article-6-1-annex-i-product-route

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, "Reassessment on a change of product or assessment route",
praxikon:eu:ai-act:control:annex-i-product-route-change-gate@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0 (schema 1.5.0),
effective_at 2026-07-27T00:00:00.000Z, known_at 2026-08-14T00:00:00.000Z,
sha256 41147ad53e75659681724c69c680f6ff2bfb2f77c57493b2b88f304dd539c613,
https://www.praxikon.com/en/verkenner/control/annex-i-product-route-change-gate
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Acontrol%3Aannex-i-product-route-change-gate&effective_at=2026-07-27&known_at=2026-08-14&lang=en, accessed 2026-09-21)

Short form

praxikon:eu:ai-act:control:annex-i-product-route-change-gate@1.0.0 (sha256 41147ad5)

BibTeX

@misc{praxikon-eu-ai-act-control-annex-i-product-route-change-gate-1-0-0,
  author       = {{Praxikon}},
  title        = {Reassessment on a change of product or assessment route},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:control:annex-i-product-route-change-gate},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.2.0, schema 1.5.0},
  note         = {effective_at 2026-07-27T00:00:00.000Z; known_at 2026-08-14T00:00:00.000Z; sha256 41147ad53e75659681724c69c680f6ff2bfb2f77c57493b2b88f304dd539c613},
  url          = {https://www.praxikon.com/en/verkenner/control/annex-i-product-route-change-gate},
  urldate      = {2026-09-21},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:control:annex-i-product-route-change-gate@1.0.0",
    "type": "dataset",
    "title": "Reassessment on a change of product or assessment route",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:control:annex-i-product-route-change-gate",
    "URL": "https://www.praxikon.com/en/verkenner/control/annex-i-product-route-change-gate",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          14
        ]
      ]
    },
    "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 2026-07-27T00:00:00.000Z; known_at 2026-08-14T00:00:00.000Z; sha256 41147ad53e75659681724c69c680f6ff2bfb2f77c57493b2b88f304dd539c613; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Acontrol%3Aannex-i-product-route-change-gate&effective_at=2026-07-27&known_at=2026-08-14&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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