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Articles 43-49: conformity assessment, CE and registration

The route from assessment to CE marking and EU database registration before market placement of high-risk AI.

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:obligation:conformity-ce-registration
Payload hash (sha256)
c7ed9f3d6c6ac6c7ff60ed44f136df9bffaada38c407b820dec2750128bd8fe4

Citation line

Praxikon, "Articles 43-49: conformity assessment, CE and registration", praxikon:eu:ai-act:obligation:conformity-ce-registration@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 c7ed9f3d6c6ac6c7ff60ed44f136df9bffaada38c407b820dec2750128bd8fe4
Version
1.0.0
Legal time (effective_at)
27 July 2026
Knowledge time (known_at)
8 August 2026
Closed on
Not closed
Application date
2 December 2027
Topics
conformity

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.

Who must act and who is affected

On an obligation the addressee is recorded separately from the party that is merely affected. That difference decides who a supervisory authority addresses and who has work to do without the duty resting on them.

Duty holder

Affected actor

Not recorded on this object.

Oversight

Not recorded on this object.

Evidence owner

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.

Who carries the duty

2 of 2 shown

The duty rests on this role. A supervisory authority addresses this role when it is not met.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Articles 43, 47, 48 and 49

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places a high-risk system on the market; public deployers also register their use.
    • ExceptionFor most Annex III systems internal control suffices (Annex VI); a notified body is required for certain biometrics and where harmonised standards are lacking.

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

    Consequence

Who owns the evidence

2 of 2 shown

This duty holder creates, maintains and can produce the evidence.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Articles 43, 47, 48 and 49

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places a high-risk system on the market; public deployers also register their use.
    • ExceptionFor most Annex III systems internal control suffices (Annex VI); a notified body is required for certain biometrics and where harmonised standards are lacking.

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

    Consequence

What has to be done

1 of 1 shown

This is what concretely has to be done under the obligation.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Articles 43, 47, 48 and 49

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places a high-risk system on the market; public deployers also register their use.
    • ExceptionFor most Annex III systems internal control suffices (Annex VI); a notified body is required for certain biometrics and where harmonised standards are lacking.

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

    Consequence

What has to be recorded

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: Articles 43, 47, 48 and 49

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places a high-risk system on the market; public deployers also register their use.
    • ExceptionFor most Annex III systems internal control suffices (Annex VI); a notified body is required for certain biometrics and where harmonised standards are lacking.

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

    Consequence

    • EvidenceConformity file

      praxikon:eu:ai-act:evidence:conformity-ce-registration-record

What keeps it in place

1 of 1 shown

This is what keeps compliance in place over time, periodic or event-driven.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Articles 43, 47, 48 and 49

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places a high-risk system on the market; public deployers also register their use.
    • ExceptionFor most Annex III systems internal control suffices (Annex VI); a notified body is required for certain biometrics and where harmonised standards are lacking.

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

    Consequence

Public tools

1 of 1 shown

This is the public route a reader can actually use.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Articles 43, 47, 48 and 49

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places a high-risk system on the market; public deployers also register their use.
    • ExceptionFor most Annex III systems internal control suffices (Annex VI); a notified body is required for certain biometrics and where harmonised standards are lacking.

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

    Consequence

What points at this object

Objects hanging off this obligation

12 of 30 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: Articles 43, 47, 48 and 49

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Complete the conformity route before market placement

    Consequence

  2. Source

    Official fact on this object, with its locator.

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

      Locator: Draft guidelines of 19 May 2026, annexes on Annex I and Annex III

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Draft guidelines on high-risk classification

    Consequence

  3. Source

    Official fact on this object, with its locator.

    • Digital Omnibus on AI 2026/1744

      Locator: Regulation (EU) 2026/1744, amended application dates under Article 113

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: High-risk AI embedded in regulated products

    Consequence

  4. 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: Articles 43, 47, 48 and 49

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Reassessment on substantial modification

    Consequence

  5. 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: Articles 43, 47, 48 and 49

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Conformity file

    Consequence

    • EvidenceConformity file

      praxikon:eu:ai-act:evidence:conformity-ce-registration-record

  6. 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, annex on Annex I and product legislation

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Agriculture: AI system targeting land areas for chemical spraying

    Consequence

  7. 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, annex on Annex I and product legislation

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Agriculture: AI for yield forecasting and irrigation optimisation

    Consequence

  8. 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, annex on Annex I and product legislation

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: ATEX: AI system monitoring gas concentrations and commanding shutdown

    Consequence

  9. 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, annex on Annex I and product legislation

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Gas appliances: AI optimising combustion efficiency

    Consequence

  10. 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, annex on Annex I and product legislation

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Lifts: AI system managing door closing timing and obstacle detection

    Consequence

  11. 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, annex on Annex I and product legislation

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Machinery: vision system detecting humans in a robot cell

    Consequence

  12. 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, annex on Annex I and product legislation

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Pressure equipment: AI system predicting runaway pressure and actuating protection

    Consequence

Open the full list in the explorer

The list there can be slightly wider than this group: the filter also counts the object itself, and for a role the broader role above it.

What this object states

Official fact

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

  • Article 43 governs the conformity assessment, Article 47 the EU declaration of conformity, Article 48 the CE marking and Article 49 the registration in the EU database before market placement or putting into service, including registration of the Article 6(3) assessment.

  • For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.

    • Locator: Amended Article 113 application datespraxikon:eu:ai-act:source:reg-eu-2026-1744Open official source

Our interpretation

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

  • For buyers this is the simplest supplier check there is: ask for the declaration of conformity and the registration number. No declaration means the system may not be there by 2 December 2027.

Recommended step

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

  • Plan the conformity route backwards from 2 December 2027: standards selection, assessment, declaration and registration together take months, not weeks.

When this applies

  1. 1The provider places a high-risk system on the market; public deployers also register their use.

When this does not apply

  • For most Annex III systems internal control suffices (Annex VI); a notified body is required for certain biometrics and where harmonised standards are lacking.

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, "Articles 43-49: conformity assessment, CE and registration",
praxikon:eu:ai-act:obligation:conformity-ce-registration@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0),
effective_at 2026-07-27T00:00:00.000Z, known_at 2026-08-08T00:00:00.000Z,
sha256 c7ed9f3d6c6ac6c7ff60ed44f136df9bffaada38c407b820dec2750128bd8fe4,
https://www.praxikon.com/en/verkenner/obligation/conformity-ce-registration
(https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aconformity-ce-registration&effective_at=2026-07-27&known_at=2026-08-08&lang=en, accessed 2026-08-25)

Short form

praxikon:eu:ai-act:obligation:conformity-ce-registration@1.0.0 (sha256 c7ed9f3d)

BibTeX

@misc{praxikon-eu-ai-act-obligation-conformity-ce-registration-1-0-0,
  author       = {{Praxikon}},
  title        = {Articles 43-49: conformity assessment, CE and registration},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:obligation:conformity-ce-registration},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.1.0, schema 1.4.0},
  note         = {effective_at 2026-07-27T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 c7ed9f3d6c6ac6c7ff60ed44f136df9bffaada38c407b820dec2750128bd8fe4},
  url          = {https://www.praxikon.com/en/verkenner/obligation/conformity-ce-registration},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:obligation:conformity-ce-registration@1.0.0",
    "type": "dataset",
    "title": "Articles 43-49: conformity assessment, CE and registration",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:obligation:conformity-ce-registration",
    "URL": "https://www.praxikon.com/en/verkenner/obligation/conformity-ce-registration",
    "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 2026-07-27T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 c7ed9f3d6c6ac6c7ff60ed44f136df9bffaada38c407b820dec2750128bd8fe4; retrieved_from https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aconformity-ce-registration&effective_at=2026-07-27&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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