Comparison

Conformity assessment versus quality management system

The quality management system of Article 17 is the continuous arrangement: policy, procedures and responsibilities with which a provider organises and sustains its own compliance. The route of Articles 43 to 49 is the moment: the assessment, the EU declaration of conformity, the CE marking and the registration, completed before the system reaches the market.

The official source remains authoritative. This is general interpretation and not legal advice about your situation.

The fields side by side

Every row comes from the objects themselves. Where a field is empty, it says so; we do not fill in an assumption where the source is silent.

Conformity assessment versus quality management system
Field	Articles 43 to 49, assessment and registration	Article 17, quality management system
Status	Applicable	Upcoming
Applies from	2 August 2026	2 December 2027
Who carries the duty	Provider of an AI system, Body governed by public law	Provider of an AI system
Who is affected	Not recorded	Not recorded
Who supervises	Not recorded	Not recorded
When this applies	The provider places a high-risk system on the market; public deployers also register their use.	The provider places high-risk AI systems on the market or puts them into service.
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.	Providers already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form.
First actions	Complete the conformity route before market placement	Set up an AI quality management system
Evidence that belongs with it	Conformity file	QMS documentation
Control	Reassessment on substantial modification	Internal audit cycle
Version and review status	v2.0.0, placed against the official source	v1.0.0, placed against the official source

Status

Articles 43 to 49, assessment and registration: Applicable
Article 17, quality management system: Upcoming

Applies from

Articles 43 to 49, assessment and registration: 2 August 2026
Article 17, quality management system: 2 December 2027

Who carries the duty

Articles 43 to 49, assessment and registration: Provider of an AI system, Body governed by public law
Article 17, quality management system: Provider of an AI system

Who is affected

Articles 43 to 49, assessment and registration: Not recorded
Article 17, quality management system: Not recorded

Who supervises

Articles 43 to 49, assessment and registration: Not recorded
Article 17, quality management system: Not recorded

When this applies

Articles 43 to 49, assessment and registration: The provider places a high-risk system on the market; public deployers also register their use.
Article 17, quality management system: The provider places high-risk AI systems on the market or puts them into service.

Exceptions

Articles 43 to 49, assessment and registration: For most Annex III systems internal control suffices (Annex VI); a notified body is required for certain biometrics and where harmonised standards are lacking.
Article 17, quality management system: Providers already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form.

First actions

Articles 43 to 49, assessment and registration: Complete the conformity route before market placement
Article 17, quality management system: Set up an AI quality management system

Evidence that belongs with it

Articles 43 to 49, assessment and registration: Conformity file
Article 17, quality management system: QMS documentation

Control

Articles 43 to 49, assessment and registration: Reassessment on substantial modification
Article 17, quality management system: Internal audit cycle

Version and review status

Articles 43 to 49, assessment and registration: v2.0.0, placed against the official source
Article 17, quality management system: v1.0.0, placed against the official source

Articles 43-49: conformity assessment, CE and registration Article 17: quality management system

Official sources and locators

Per side, the provisions the statements above rest on.

Articles 43 to 49, assessment and registration

EU Artificial Intelligence Act 2024/1689
Locator: Articles 43, 47, 48 and 49
Open official source
EU Artificial Intelligence Act 2024/1689
Locator: Article 113, second paragraph
Open official source
Digital Omnibus on AI 2026/1744
Locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)
Open official source

Article 17, quality management system

EU Artificial Intelligence Act 2024/1689
Locator: Article 17(1)-(3)
Open official source
Digital Omnibus on AI 2026/1744
Locator: Amended Article 113 application dates
Open official source

Referring to these two objects

Each side has its own stable identifier, version and hash. Take them separately; you cite a comparison by citing the two objects.

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 2026-10-08)

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      = {2026-10-08},
  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,
          10,
          8
        ]
      ]
    },
    "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

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, "Article 17: quality management system",
praxikon:eu:ai-act:obligation:article-17-quality-management@1.0.0,
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 2026-08-08T00:00:00.000Z,
sha256 7d04f5f23729c5c48f26262f0e266c680dce5753d12543479b1ea672bbe1c6e9,
https://www.praxikon.com/en/verplichtingen/article-17-quality-management
(https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-17-quality-management&effective_at=2026-07-27&known_at=2026-08-08&lang=en, accessed 2026-10-08)

Short form

praxikon:eu:ai-act:obligation:article-17-quality-management@1.0.0 (sha256 7d04f5f2)

BibTeX

@misc{praxikon-eu-ai-act-obligation-article-17-quality-management-1-0-0,
  author       = {{Praxikon}},
  title        = {Article 17: quality management system},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:obligation:article-17-quality-management},
  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 2026-08-08T00:00:00.000Z; sha256 7d04f5f23729c5c48f26262f0e266c680dce5753d12543479b1ea672bbe1c6e9},
  url          = {https://www.praxikon.com/en/verplichtingen/article-17-quality-management},
  urldate      = {2026-10-08},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:obligation:article-17-quality-management@1.0.0",
    "type": "dataset",
    "title": "Article 17: quality management system",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:obligation:article-17-quality-management",
    "URL": "https://www.praxikon.com/en/verplichtingen/article-17-quality-management",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          8
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          10,
          8
        ]
      ]
    },
    "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 2026-08-08T00:00:00.000Z; sha256 7d04f5f23729c5c48f26262f0e266c680dce5753d12543479b1ea672bbe1c6e9; retrieved_from https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-17-quality-management&effective_at=2026-07-27&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

Have it done

Put the route to market in order

The continuous arrangement and the assessment moment call for different documents, in a different order, with different owners. The readiness check for AI providers tests your documentation against what the AI Act asks of a provider and delivers a prioritised list of gaps.

Readiness check for AI providers · €2,950 or €4,950 · AI model or Annex III system · 3 to 5 working days

See the readiness check

Carried out by Zahed Ashkara, the lawyer behind this explanation.

Unsure about your role itself rather than the duties that come with it? Work out whether you are a provider or a deployer

The fields side by side

Official sources and locators

Articles 43 to 49, assessment and registration

Article 17, quality management system

Referring to these two objects

Citation block

Citation block

Put the route to market in order

Other comparisons