StandardGuidancev1.0.0

prEN 18285: conformity assessment framework for AI systems

The draft European standard operationalising the conformity assessment procedure of Article 43 and Annex VII.

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:standard:standard-pren-18285-conformity-assessment-framework
Payload hash (sha256): 6912ad1f00cd9830b1995fd9ea6e88df0aeb116adb20a4655378cb061d173ff0

Citation line

Praxikon, "prEN 18285: conformity assessment framework for AI systems", praxikon:eu:ai-act:standard:standard-pren-18285-conformity-assessment-framework@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 6912ad1f00cd9830b1995fd9ea6e88df0aeb116adb20a4655378cb061d173ff0

Version: 1.0.0
Legal time (effective_at): 8 August 2026
Knowledge time (known_at): 8 August 2026
Closed on: Not closed
Topics: standards

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.
- CEN-CENELEC JTC 21: European standards under standardisation request M/613
  Locator: prEN 18285 (draft standard), CEN/CLC/JTC 21 under M/613
  praxikon:eu:ai-act:source:cen-cenelec-jtc21
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 43 and Annex VII; Article 22; Article 40
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allThe Article 43 conformity assessment rests on the provider. The authorised representative established in the Union keeps the EU declaration of conformity and the technical documentation available to the supervisory authority and cooperates with it under Article 22.
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.
- CEN-CENELEC JTC 21: European standards under standardisation request M/613
  Locator: prEN 18285 (draft standard), CEN/CLC/JTC 21 under M/613
  praxikon:eu:ai-act:source:cen-cenelec-jtc21
  Open official source
- EU Artificial Intelligence Act 2024/1689
  Locator: Article 43 and Annex VII; Article 22; Article 40
  praxikon:eu:ai-act:source:reg-eu-2024-1689
  Open official source
Via
- Condition | allThe Article 43 conformity assessment rests on the provider. The authorised representative established in the Union keeps the EU declaration of conformity and the technical documentation available to the supervisory authority and cooperates with it under Article 22.
Consequence
- ActorAuthorised representative
  praxikon:eu:ai-act:actor:authorised-representative
- 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.

prEN 18285 (Conformity assessment framework) is the JTC 21 deliverable under M/613 covering the conformity assessment of high-risk AI systems under Article 43 and Annex VII of the AI Act. As at June 2026 the deliverable was at the drafting stage. It has not yet been published as an EN and is not cited in the Official Journal. Standardisation request M/613 was amended by Implementing Decision C(2025)3871 of 23 June 2025 and expires on 28 February 2027.
- Locator: prEN 18285 (draft standard), CEN/CLC/JTC 21 under M/613praxikon:eu:ai-act:source:cen-cenelec-jtc21Open official source
- Locator: Article 43 and Annex VII; Article 22; Article 40praxikon:eu:ai-act:source:reg-eu-2024-1689Open 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 the deliverable that determines how heavily the rest weighs. For most Annex III systems the provider may self-assess (internal control), but that does not mean nothing is required: it means you must be able to show the complete dossier yourself. The trap is thinking self-assessment is light. The notified body is absent, the burden of proof is not. While prEN 18285 remains in draft, there is no recognised blueprint for that self-assessment and you must justify the structure yourself.
- Locator: prEN 18285 (draft standard), CEN/CLC/JTC 21 under M/613praxikon:eu:ai-act:source:cen-cenelec-jtc21Open official source
- Locator: Article 43 and Annex VII; Article 22; Article 40praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

Recommended step

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

Determine per system which assessment route applies (internal control or notified body) and build your dossier as one an external party would have to be able to read, even where you self-assess. Plan backwards from 2 December 2027 for standalone Annex III systems and 2 August 2028 for systems embedded in regulated products.
- Locator: prEN 18285 (draft standard), CEN/CLC/JTC 21 under M/613praxikon:eu:ai-act:source:cen-cenelec-jtc21Open official source
- Locator: Article 43 and Annex VII; Article 22; Article 40praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

When this applies

1The Article 43 conformity assessment rests on the provider. The authorised representative established in the Union keeps the EU declaration of conformity and the technical documentation available to the supervisory authority and cooperates with it under Article 22.

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, "prEN 18285: conformity assessment framework for AI systems",
praxikon:eu:ai-act:standard:standard-pren-18285-conformity-assessment-framework@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 6912ad1f00cd9830b1995fd9ea6e88df0aeb116adb20a4655378cb061d173ff0,
https://www.praxikon.com/en/verkenner/standard/standard-pren-18285-conformity-assessment-framework
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Astandard%3Astandard-pren-18285-conformity-assessment-framework&effective_at=2026-08-08&known_at=2026-08-08&lang=en, accessed 2026-08-25)

Short form

praxikon:eu:ai-act:standard:standard-pren-18285-conformity-assessment-framework@1.0.0 (sha256 6912ad1f)

BibTeX

@misc{praxikon-eu-ai-act-standard-standard-pren-18285-conformity-assessment-framework-1-0-0,
  author       = {{Praxikon}},
  title        = {prEN 18285: conformity assessment framework for AI systems},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:standard:standard-pren-18285-conformity-assessment-framework},
  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 6912ad1f00cd9830b1995fd9ea6e88df0aeb116adb20a4655378cb061d173ff0},
  url          = {https://www.praxikon.com/en/verkenner/standard/standard-pren-18285-conformity-assessment-framework},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

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    "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 6912ad1f00cd9830b1995fd9ea6e88df0aeb116adb20a4655378cb061d173ff0; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Astandard%3Astandard-pren-18285-conformity-assessment-framework&effective_at=2026-08-08&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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