GuidanceGuidancev1.0.0

Module choice does not change the classification

The fact that a manufacturer may opt for internal control based on harmonised standards does not affect the high-risk classification. Classification follows the level of enhanced scrutiny required by the product legislation, not the procedure chosen.

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:guidance:guidance-high-risk-third-party-conformity-assessment-module-choice
Payload hash (sha256): 81c96c1b43f6d6e80d5cbf98a9485b411e186e75b1d5e77f2efd6932c7dad7b4

Citation line

Praxikon, "Module choice does not change the classification", praxikon:eu:ai-act:guidance:guidance-high-risk-third-party-conformity-assessment-module-choice@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 81c96c1b43f6d6e80d5cbf98a9485b411e186e75b1d5e77f2efd6932c7dad7b4

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

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
Official fact on this object, with its locator.
- Draft guidelines on the classification of high-risk AI systems
  Locator: Draft guidelines Annex I, points (50) to (59)
  praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ObligationArticles 43-49: conformity assessment, CE and registration
  praxikon:eu:ai-act:obligation:conformity-ce-registration

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.

Source
Official fact on this object, with its locator.
- Draft guidelines on the classification of high-risk AI systems
  Locator: Draft guidelines Annex I, points (50) to (59)
  praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines
  Open official source
Via
No condition or exception recorded on this object.
Consequence
- ActorDeployer
  praxikon:eu:ai-act:actor:deployer
- ActorProvider of an AI system
  praxikon:eu:ai-act:actor:provider

What this object states

Official fact

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

The draft guidelines of 19 May 2026 have the status of a non-binding draft and clarify the second condition as follows. The AI Act does not itself determine the applicable conformity assessment procedures but relies on the choice of procedures established under the Annex I harmonisation legislation. Decision 768/2008/EC sets out eight main modules A to H. For all modules except module A the involvement of a notified body is required; module C does not require such involvement but is always combined with modules that do; for modules A1 and A2 a notified body or accredited in-house body is required only in the production phase. The draft guidelines then state explicitly that the fact that harmonisation legislation may allow a manufacturer to rely on internal control based on harmonised standards, as one procedural option, does not affect the classification of an AI system as high-risk under Article 6(1). The choice of module gives the manufacturer procedural flexibility to demonstrate compliance but confers no discretion to determine the risk classification under the AI Act. The decisive factor is that the product, under the Annex I legislation, is subject to enhanced regulatory scrutiny before it may lawfully be placed on the market, scrutiny ensured through the requirement of third-party conformity assessment or equivalent mechanisms, including internal control subject to mandatory application of harmonised standards published in the Official Journal. The draft guidelines point out that the Union legislature expressly confirmed this logic in recital 15 of Regulation (EU) 2025/2509 on the safety of toys.
- Locator: Draft guidelines Annex I, points (50) to (59)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.

Here the draft guidelines close the most obvious escape route. The reasoning many manufacturers hoped to use ran: we apply harmonised standards, therefore we use module A, therefore no third party is involved, therefore we are not high-risk. The Commission reverses that. What matters is not the chosen procedure but the level of protection the legislature considered necessary for that product type. Anyone who has built the module A route into their compliance planning must now revisit that assumption. The toys and machinery regulations are explicitly named as sectors where this plays out.
- Locator: Draft guidelines Annex I, points (50) to (59)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.

Test your classification not against the module you actually use, but against whether the legislature prescribed enhanced scrutiny for your product type. If your sectoral legislation permits internal control only subject to mandatory application of harmonised standards, assume you fall within the high-risk regime and plan your AI Act track accordingly.
- Locator: Draft guidelines Annex I, points (50) to (59)praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelinesOpen official source

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, "Module choice does not change the classification",
praxikon:eu:ai-act:guidance:guidance-high-risk-third-party-conformity-assessment-module-choice@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 81c96c1b43f6d6e80d5cbf98a9485b411e186e75b1d5e77f2efd6932c7dad7b4,
https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-third-party-conformity-assessment-module-choice
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aguidance%3Aguidance-high-risk-third-party-conformity-assessment-module-choice&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-third-party-conformity-assessment-module-choice@1.0.0 (sha256 81c96c1b)

BibTeX

@misc{praxikon-eu-ai-act-guidance-guidance-high-risk-third-party-conformity-assessment-module-choice-1-0-0,
  author       = {{Praxikon}},
  title        = {Module choice does not change the classification},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:guidance:guidance-high-risk-third-party-conformity-assessment-module-choice},
  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 81c96c1b43f6d6e80d5cbf98a9485b411e186e75b1d5e77f2efd6932c7dad7b4},
  url          = {https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-third-party-conformity-assessment-module-choice},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:guidance:guidance-high-risk-third-party-conformity-assessment-module-choice@1.0.0",
    "type": "dataset",
    "title": "Module choice does not change the classification",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:guidance:guidance-high-risk-third-party-conformity-assessment-module-choice",
    "URL": "https://www.praxikon.com/en/verkenner/guidance/guidance-high-risk-third-party-conformity-assessment-module-choice",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          8
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          8,
          25
        ]
      ]
    },
    "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 81c96c1b43f6d6e80d5cbf98a9485b411e186e75b1d5e77f2efd6932c7dad7b4; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aguidance%3Aguidance-high-risk-third-party-conformity-assessment-module-choice&effective_at=2026-08-08&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

How to verify a reference later is set out in the methodology. Terms

For agents and integrations

This page and the machine output come from the same object and the same two time axes.

Open as JSON Open as JSON-LD Read the methodology