Applicablev2.0.0

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.

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.

Praxikon tracks Articles 43-49: conformity assessment, CE and registration under the EU AI Act, checked against the official source on 6 September 2026, citing the source for every statement.

Status: Applicable
Application date: 2 August 2026
Version: 2.0.0
Last reviewed: 6 September 2026

Review status: placed against the official source (6 September 2026). Next check due by 5 March 2027. The check date is the knowledge date of this version; no later recheck has been recorded.

From source to evidence

Why this obligation applies, what it asks of you, and what you show for it.

Applies

Applicable · 2 August 2026

For whom

Provider of an AI system
Body governed by public law

What you do

Complete the conformity route before market placement

What you record

Conformity file

Official source

Articles 43, 47, 48 and 49

Who this is relevant to

When this applies

Provider of an AI system
A party that develops or has an AI system developed and places it on the market under its own name.
Body governed by public law
A deployer that is a body governed by public law.

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

What the official source establishes

This provision is named in none of the three points of Article 113, third paragraph, and therefore falls under the general application date in the second paragraph: 2 August 2026. The move to 2 December 2027 and 2 August 2028 in point (c) concerns only Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5). When a high-risk AI system that this provision addresses can practically exist is a second question: through Article 6(2) and Annex III that is 2 December 2027, and through Article 6(1) and Annex I 2 August 2028. That practical date sits in high_risk_regime_from and not in deadline_at. This is how decision D1 of 6 September 2026 is recorded; see data/ai-act/review/decision-d1-application-dates.json.

Our interpretation

The official source remains authoritative. This general interpretation is not legal advice.

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.

What you can do now

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

01
Complete the conformity route before market placement
Select the correct assessment procedure, draw up the EU declaration of conformity, affix the CE marking and register in the EU database.

What to retain

Conformity file

The assessment, EU declaration of conformity, CE marking and registration proof, per system version.

Control and reassessment

Reassessment on substantial modification
Rerun the conformity route whenever the system is substantially modified.

Public tools

Full text of Article 43
The full legal text in the public AI Act Explorer.
Read Article 43 in the AI Act Explorer

Conditions and exceptions

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

Official sources and locators

EU Artificial Intelligence Act 2024/1689
European Parliament and Council | original-oj-2024-07-12
Source locator: Articles 43, 47, 48 and 49
Open official source
EU Artificial Intelligence Act 2024/1689
European Parliament and Council | original-oj-2024-07-12
Source locator: Article 113, second paragraph
Open official source
Digital Omnibus on AI 2026/1744
European Parliament and Council | official-journal-2026-07-24
Source locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)
Open official source

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@2.0.0,
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 2026-09-06T00:00:00.000Z,
sha256 e2ba6e413ff6670e5896f31ee36839ff048b04b714b4c13decc1ed8e0d2f9186,
https://www.praxikon.com/en/verplichtingen/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=2026-09-06&lang=en, accessed 2026-09-07)

Short form

praxikon:eu:ai-act:obligation:conformity-ce-registration@2.0.0 (sha256 e2ba6e41)

BibTeX

@misc{praxikon-eu-ai-act-obligation-conformity-ce-registration-2-0-0,
  author       = {{Praxikon}},
  title        = {Articles 43-49: conformity assessment, CE and registration},
  year         = {2026},
  version      = {2.0.0},
  number       = {praxikon:eu:ai-act:obligation:conformity-ce-registration},
  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 2026-09-06T00:00:00.000Z; sha256 e2ba6e413ff6670e5896f31ee36839ff048b04b714b4c13decc1ed8e0d2f9186},
  url          = {https://www.praxikon.com/en/verplichtingen/conformity-ce-registration},
  urldate      = {2026-09-07},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:obligation:conformity-ce-registration@2.0.0",
    "type": "dataset",
    "title": "Articles 43-49: conformity assessment, CE and registration",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "2.0.0",
    "number": "praxikon:eu:ai-act:obligation:conformity-ce-registration",
    "URL": "https://www.praxikon.com/en/verplichtingen/conformity-ce-registration",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          9,
          6
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          9,
          7
        ]
      ]
    },
    "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 2026-09-06T00:00:00.000Z; sha256 e2ba6e413ff6670e5896f31ee36839ff048b04b714b4c13decc1ed8e0d2f9186; 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=2026-09-06&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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

What changed in this

Moments when this obligation took effect, moved or received official guidance.

2028-08-02 | upcoming
High-risk AI embedded in regulated products
AI as a safety component of products under Annex I follows on 2 August 2028.
2027-08-02 | binding law
New Article 2(13): requirements for Annex I systems may be limited
Since 27 July 2026 the application of the requirements or obligations in Articles 9 to 15 and 17 to 25 may be limited for high-risk systems referred to in Article 6(1) where the Annex I Section A harmonisation legislation provides an equivalent or higher level of protection. That limitation exists only once a delegated act is adopted, which must happen by 2 August 2027. Until then the requirements apply in full.
2026-07-27 | binding law
Machinery moves from Annex I, Section A, to Section B
Since 27 July 2026 point 1 of Section A of Annex I, the machinery directive, has been deleted and Regulation (EU) 2023/1230 has been added as point 21 to Section B. For AI in machinery the limited regime of the amended Article 2(2) therefore applies: only Article 6(1), Article 60a and Articles 102 to 112.
2026-07-27 | binding law
Article 6 gains paragraphs 1a to 1c on safety components
Since 27 July 2026 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, unless failure or malfunctioning would endanger health and safety. A product required to undergo a third-party assessment only because of radio spectrum or electromagnetic interference that does not affect health and safety does not fulfil the condition in paragraph 1, point (b).
2026-05-19 | guidance
Draft guidelines on high-risk classification
The Commission explains in consultation when a system falls under Annex I or Annex III.

See the full timeline

Version history

v2.0.0
27 July 2026
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.
v1.0.0
27 July 2026
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.

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Expert behind this page

Zahed Ashkara

Lawyer and AI governance specialist

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Execution

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