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GuidanceGuidancev1.0.0

First the definition question: is it an AI system at all?

Before classification comes into play, the system must meet the definition of an AI system in Article 3(1). Not every software application and not every automated decision-making system falls within the AI Act.

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

Address and citation

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Identifier
praxikon:eu:ai-act:guidance:guidance-high-risk-must-first-be-an-ai-system
Payload hash (sha256)
eb62d3811c86970025c6b5235267569779e7a3149fe73059a242756c17a2368f

Citation line

Praxikon, "First the definition question: is it an AI system at all?", praxikon:eu:ai-act:guidance:guidance-high-risk-must-first-be-an-ai-system@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 eb62d3811c86970025c6b5235267569779e7a3149fe73059a242756c17a2368f
Version
1.0.0
Legal time (effective_at)
8 August 2026
Knowledge time (known_at)
8 August 2026
Closed on
Not closed
Topics
guidance

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.

What this object links to

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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

    Official fact on this object, with its locator.

    • Draft guidelines on the classification of high-risk AI systems

      Locator: Draft guidelines on high-risk AI classification (19 May 2026), General principles chapter, section II.1, paragraphs (8) and (9)

      praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines

      Open official source

    Via

    No condition or exception recorded on this object.

    Consequence

What this object is about

2 of 2 shown

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

  1. Source

    Official fact on this object, with its locator.

    • Draft guidelines on the classification of high-risk AI systems

      Locator: Draft guidelines on high-risk AI classification (19 May 2026), General principles chapter, section II.1, paragraphs (8) and (9)

      praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines

      Open official source

    Via

    No condition or exception recorded on this object.

    Consequence

What this object states

Official fact

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

  • According to the non-binding draft guidelines of 19 May 2026 on the classification of high-risk AI, before a system can be classified as high-risk it must first qualify as an AI system within the meaning of Article 3(1) of the AI Act (paragraph 8). Paragraph (9) of that draft states expressly that not every software application or automated decision-making system falls within the scope of the regulation, and refers for the interpretation of the definition to the separate guidelines on the definition of an AI system (C(2025) 5053).

    • Locator: Draft guidelines on high-risk AI classification (19 May 2026), General principles chapter, section II.1, paragraphs (8) and (9)praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelinesOpen official source

Our interpretation

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

  • This is a genuine preliminary question, not a formality. Classic rule-based software, fixed calculation rules and simple automation that does not infer from input how to generate output never reach the classification question. At the same time this is not an escape route: the definition guidelines are broad and in practice the burden of showing that something falls outside the definition rests on you.

    • Locator: Draft guidelines on high-risk AI classification (19 May 2026), General principles chapter, section II.1, paragraphs (8) and (9)praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelinesOpen official source

Recommended step

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

  • Include an explicit definition-test field in your AI register, with the reasoning why a system is or is not an AI system. Run that test before you invest time in the Annex I or Annex III analysis, and record the result so you can show it during an inspection.

    • Locator: Draft guidelines on high-risk AI classification (19 May 2026), General principles chapter, section II.1, paragraphs (8) and (9)praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelinesOpen official source

When this applies

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When this does not apply

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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, "First the definition question: is it an AI system at all?",
praxikon:eu:ai-act:guidance:guidance-high-risk-must-first-be-an-ai-system@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 eb62d3811c86970025c6b5235267569779e7a3149fe73059a242756c17a2368f,
https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-must-first-be-an-ai-system
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aguidance%3Aguidance-high-risk-must-first-be-an-ai-system&effective_at=2026-08-08&known_at=2026-08-08&lang=en, accessed 2026-08-25)

Short form

praxikon:eu:ai-act:guidance:guidance-high-risk-must-first-be-an-ai-system@1.0.0 (sha256 eb62d381)

BibTeX

@misc{praxikon-eu-ai-act-guidance-guidance-high-risk-must-first-be-an-ai-system-1-0-0,
  author       = {{Praxikon}},
  title        = {First the definition question: is it an AI system at all?},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:guidance:guidance-high-risk-must-first-be-an-ai-system},
  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 eb62d3811c86970025c6b5235267569779e7a3149fe73059a242756c17a2368f},
  url          = {https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-must-first-be-an-ai-system},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

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    "title": "First the definition question: is it an AI system at all?",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:guidance:guidance-high-risk-must-first-be-an-ai-system",
    "URL": "https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-must-first-be-an-ai-system",
    "language": "en",
    "issued": {
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    "accessed": {
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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 eb62d3811c86970025c6b5235267569779e7a3149fe73059a242756c17a2368f; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aguidance%3Aguidance-high-risk-must-first-be-an-ai-system&effective_at=2026-08-08&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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