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ObligationApplicablev1.0.0

Article 44: certificates of notified bodies

A certificate issued by a notified body is valid for at most five years for AI systems covered by Annex I and at most four years for AI systems covered by Annex III, and may be extended at the request of the provider after a re-assessment. Where the system no longer meets the requirements of Section 2, the body shall, taking account of the principle of proportionality, suspend or withdraw the certificate or impose restrictions on it, unless the provider takes corrective action within an appropriate deadline it sets so as to ensure compliance with those requirements. An appeal procedure against that decision is available.

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:article-44-notified-body-certificates
Payload hash (sha256)
458f4f14180a115bbccca9bac5e76eae0e9642c92bc0831b57b8e803ebb447b9

Citation line

Praxikon, "Article 44: certificates of notified bodies", praxikon:eu:ai-act:obligation:article-44-notified-body-certificates@1.0.0, dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0 (schema 1.5.0), effective_at 2026-08-08T00:00:00.000Z, known_at 2026-09-06T00:00:00.000Z, sha256 458f4f14180a115bbccca9bac5e76eae0e9642c92bc0831b57b8e803ebb447b9
Version
1.0.0
Legal time (effective_at)
2 August 2026
Knowledge time (known_at)
14 August 2026
Closed on
Not closed
Application date
2 August 2026
Topics
conformity

Review status: Placed against the official source (14 August 2026). Next check due by 10 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.

No duty holder assigned

The addressee falls outside the roles this dataset models. The duty exists, it just does not rest on a role recorded here.

Duty holder

Not recorded on this object.

Affected actor

Oversight

Not recorded on this object.

Evidence owner

Not recorded on this object.

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 is affected without being the addressee

1 of 1 shown

This role is practically affected without being the addressee: it receives the information, has to cooperate, or absorbs the consequences in its own process.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 44(1)-(3)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 43(1), (2) and (4)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (19), replacing Article 43(3)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex I

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 36(3), (5), (7), (8) and (9)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 45(2), point (b)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Chapter III, Section 5, and Article 113, second paragraph

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

      Open official source

    Via

    • Condition | allApplies as soon as a notified body has issued a certificate for a high-risk AI system. That happens along two routes. The certificate under Annex VII, which under Article 43(1) and (2) arises within Annex III only for the biometrics of point 1. There it can arise along two ways: a provider who has applied harmonised standards or common specifications may under the first subparagraph of paragraph 1 choose between the internal control of Annex VI and the procedure involving a notified body of Annex VII, and the second subparagraph makes Annex VII mandatory in the four cases it lists. And the certificate issued under Article 43(3) as replaced with effect from 27 July 2026, within the sectoral conformity assessment of the products of Annex I, Section A, where the body is notified under that sectoral legislation, where the quality management system of Article 17 is assessed as well, and where point 3, points 4.3, 4.4 and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII apply. For the products of Annex I, Section B, which cover machinery since 27 July 2026, this Article has no bearing: the amended Article 2(2) makes only Article 6(1), Article 60a and Articles 102 to 112 applicable to those systems, and Article 44 is not in that list. Nor does it bear on the systems of points 2 to 8 of Annex III, which under Article 43(2) follow the internal control of Annex VI, where no notified body is involved.
    • ExceptionParagraph 3 withholds suspension, withdrawal or restriction where compliance with the requirements of Section 2 is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The principle of proportionality also allows the body to confine itself to restrictions instead of withdrawal.

    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: Article 44(1)-(3)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 43(1), (2) and (4)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (19), replacing Article 43(3)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex I

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 36(3), (5), (7), (8) and (9)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 45(2), point (b)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Chapter III, Section 5, and Article 113, second paragraph

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

      Open official source

    Via

    • Condition | allApplies as soon as a notified body has issued a certificate for a high-risk AI system. That happens along two routes. The certificate under Annex VII, which under Article 43(1) and (2) arises within Annex III only for the biometrics of point 1. There it can arise along two ways: a provider who has applied harmonised standards or common specifications may under the first subparagraph of paragraph 1 choose between the internal control of Annex VI and the procedure involving a notified body of Annex VII, and the second subparagraph makes Annex VII mandatory in the four cases it lists. And the certificate issued under Article 43(3) as replaced with effect from 27 July 2026, within the sectoral conformity assessment of the products of Annex I, Section A, where the body is notified under that sectoral legislation, where the quality management system of Article 17 is assessed as well, and where point 3, points 4.3, 4.4 and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII apply. For the products of Annex I, Section B, which cover machinery since 27 July 2026, this Article has no bearing: the amended Article 2(2) makes only Article 6(1), Article 60a and Articles 102 to 112 applicable to those systems, and Article 44 is not in that list. Nor does it bear on the systems of points 2 to 8 of Annex III, which under Article 43(2) follow the internal control of Annex VI, where no notified body is involved.
    • ExceptionParagraph 3 withholds suspension, withdrawal or restriction where compliance with the requirements of Section 2 is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The principle of proportionality also allows the body to confine itself to restrictions instead of withdrawal.

    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: Article 44(1)-(3)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 43(1), (2) and (4)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (19), replacing Article 43(3)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex I

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 36(3), (5), (7), (8) and (9)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 45(2), point (b)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Chapter III, Section 5, and Article 113, second paragraph

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

      Open official source

    Via

    • Condition | allApplies as soon as a notified body has issued a certificate for a high-risk AI system. That happens along two routes. The certificate under Annex VII, which under Article 43(1) and (2) arises within Annex III only for the biometrics of point 1. There it can arise along two ways: a provider who has applied harmonised standards or common specifications may under the first subparagraph of paragraph 1 choose between the internal control of Annex VI and the procedure involving a notified body of Annex VII, and the second subparagraph makes Annex VII mandatory in the four cases it lists. And the certificate issued under Article 43(3) as replaced with effect from 27 July 2026, within the sectoral conformity assessment of the products of Annex I, Section A, where the body is notified under that sectoral legislation, where the quality management system of Article 17 is assessed as well, and where point 3, points 4.3, 4.4 and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII apply. For the products of Annex I, Section B, which cover machinery since 27 July 2026, this Article has no bearing: the amended Article 2(2) makes only Article 6(1), Article 60a and Articles 102 to 112 applicable to those systems, and Article 44 is not in that list. Nor does it bear on the systems of points 2 to 8 of Annex III, which under Article 43(2) follow the internal control of Annex VI, where no notified body is involved.
    • ExceptionParagraph 3 withholds suspension, withdrawal or restriction where compliance with the requirements of Section 2 is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The principle of proportionality also allows the body to confine itself to restrictions instead of withdrawal.

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

    Consequence

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: Article 44(1)-(3)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 43(1), (2) and (4)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (19), replacing Article 43(3)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex I

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 36(3), (5), (7), (8) and (9)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 45(2), point (b)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Chapter III, Section 5, and Article 113, second paragraph

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

      Open official source

    Via

    • Condition | allApplies as soon as a notified body has issued a certificate for a high-risk AI system. That happens along two routes. The certificate under Annex VII, which under Article 43(1) and (2) arises within Annex III only for the biometrics of point 1. There it can arise along two ways: a provider who has applied harmonised standards or common specifications may under the first subparagraph of paragraph 1 choose between the internal control of Annex VI and the procedure involving a notified body of Annex VII, and the second subparagraph makes Annex VII mandatory in the four cases it lists. And the certificate issued under Article 43(3) as replaced with effect from 27 July 2026, within the sectoral conformity assessment of the products of Annex I, Section A, where the body is notified under that sectoral legislation, where the quality management system of Article 17 is assessed as well, and where point 3, points 4.3, 4.4 and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII apply. For the products of Annex I, Section B, which cover machinery since 27 July 2026, this Article has no bearing: the amended Article 2(2) makes only Article 6(1), Article 60a and Articles 102 to 112 applicable to those systems, and Article 44 is not in that list. Nor does it bear on the systems of points 2 to 8 of Annex III, which under Article 43(2) follow the internal control of Annex VI, where no notified body is involved.
    • ExceptionParagraph 3 withholds suspension, withdrawal or restriction where compliance with the requirements of Section 2 is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The principle of proportionality also allows the body to confine itself to restrictions instead of withdrawal.

    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: Article 44(1)-(3)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 43(1), (2) and (4)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (19), replacing Article 43(3)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex I

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 36(3), (5), (7), (8) and (9)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 45(2), point (b)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Chapter III, Section 5, and Article 113, second paragraph

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

      Open official source

    Via

    • Condition | allApplies as soon as a notified body has issued a certificate for a high-risk AI system. That happens along two routes. The certificate under Annex VII, which under Article 43(1) and (2) arises within Annex III only for the biometrics of point 1. There it can arise along two ways: a provider who has applied harmonised standards or common specifications may under the first subparagraph of paragraph 1 choose between the internal control of Annex VI and the procedure involving a notified body of Annex VII, and the second subparagraph makes Annex VII mandatory in the four cases it lists. And the certificate issued under Article 43(3) as replaced with effect from 27 July 2026, within the sectoral conformity assessment of the products of Annex I, Section A, where the body is notified under that sectoral legislation, where the quality management system of Article 17 is assessed as well, and where point 3, points 4.3, 4.4 and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII apply. For the products of Annex I, Section B, which cover machinery since 27 July 2026, this Article has no bearing: the amended Article 2(2) makes only Article 6(1), Article 60a and Articles 102 to 112 applicable to those systems, and Article 44 is not in that list. Nor does it bear on the systems of points 2 to 8 of Annex III, which under Article 43(2) follow the internal control of Annex VI, where no notified body is involved.
    • ExceptionParagraph 3 withholds suspension, withdrawal or restriction where compliance with the requirements of Section 2 is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The principle of proportionality also allows the body to confine itself to restrictions instead of withdrawal.

    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

4 of 4 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: Article 44(1)-(3)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 43(1), (2) and (4)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (19), replacing Article 43(3)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex I

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 36(3), (5), (7), (8) and (9)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 45(2), point (b)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Chapter III, Section 5, and Article 113, second paragraph

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

      Open official source

    Via

    • Condition | allTo be set up as soon as a notified body has issued a certificate, along Annex VII or along the sectoral procedure of Article 43(3), and to be revisited on every change that is substantial within the meaning of Article 43(4). Article 44 imposes no duty on the provider himself; this is the practical working out we read into it, see the note on the provision.

    Relation recorded on: Manage the life of the certificate

    Consequence

  2. 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: Article 44(1)-(3)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 43(1), (2) and (4)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (19), replacing Article 43(3)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex I

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 36(3), (5), (7), (8) and (9)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 45(2), point (b)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Chapter III, Section 5, and Article 113, second paragraph

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Monitoring of certificate, modification and body

    Consequence

  3. 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: Article 44(1)-(3)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 43(1), (2) and (4)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (19), replacing Article 43(3)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex I

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 36(3), (5), (7), (8) and (9)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 45(2), point (b)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Chapter III, Section 5, and Article 113, second paragraph

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Certificate file per system

    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: Article 44(1)-(3)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 43(1), (2) and (4)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (19), replacing Article 43(3)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex I

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 36(3), (5), (7), (8) and (9)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 45(2), point (b)

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

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Chapter III, Section 5, and Article 113, second paragraph

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

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Full text of Article 44

    Consequence

What this object states

Official fact

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

  • Paragraph 1 provides that certificates issued by notified bodies in accordance with Annex VII shall be drawn up in a language which can be easily understood by the relevant authorities in the Member State in which the notified body is established. Paragraph 2 provides that certificates shall be valid for the period they indicate, which shall not exceed five years for AI systems covered by Annex I and four years for AI systems covered by Annex III, that at the request of the provider the validity may be extended for further periods, each not exceeding five years and four years respectively, based on a re-assessment in accordance with the applicable conformity assessment procedures, and that any supplement to a certificate shall remain valid provided that the certificate which it supplements is valid. Paragraph 3 provides that where a notified body finds that an AI system no longer meets the requirements set out in Section 2, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose restrictions on it, unless compliance with those requirements is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body, that the notified body shall give reasons for its decision, and that an appeal procedure against decisions of the notified bodies, including on conformity certificates issued, shall be available.

  • Article 43 sets out along which route a certificate arises and when it must be earned again. Paragraph 1 lets the provider of the systems listed in point 1 of Annex III choose between the internal control of Annex VI and the procedure involving a notified body of Annex VII where he has applied harmonised standards or common specifications, and makes the Annex VII procedure mandatory in four cases: the harmonised standards referred to in Article 40 do not exist and the common specifications referred to in Article 41 are not available; the provider has not applied, or has applied only part of, the harmonised standard; the common specifications referred to in point (a) exist but the provider has not applied them; or one or more of the harmonised standards referred to in point (a) has been published with a restriction, and then only on the part of the standard that was restricted. Paragraph 2 provides that for the systems of points 2 to 8 of Annex III providers follow the internal control of Annex VI, for which the involvement of a notified body is not required. Paragraph 4 provides that high-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new procedure whenever they are substantially modified, regardless of whether the modified system is intended to be further distributed or continues to be used by the current deployer, and that for systems that continue to learn, changes predetermined by the provider at the moment of the initial conformity assessment and part of the technical documentation referred to in point 2(f) of Annex IV do not constitute a substantial modification.

  • Paragraph 3 of Article 43 was replaced with effect from 27 July 2026. Under the text in force, the provider of a high-risk AI system covered by the Union harmonisation legislation listed in Section A of Annex I follows the relevant conformity assessment procedure as required in accordance with that harmonisation legislation, the requirements set out in Section 2 of this Chapter apply to those systems and form part of that assessment, an assessment of the quality management system set out in Article 17 is also undertaken, and points 3, 4.3, 4.4 and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII apply. The second subparagraph gives notified bodies notified under that harmonisation legislation the power to assess the conformity of those systems with the requirements of Section 2, provided that their compliance with the requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure under that harmonisation legislation, which is evidenced through the assessment as part of the existing notification, and requires those same bodies, without prejudice to Article 28, to apply for designation in accordance with Section 4 of this Chapter by 28 January 2028. The third subparagraph provides that a manufacturer entitled under that harmonisation legislation to rely on a conformity assessment not involving a third party may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41 covering all requirements of Section 2, that the classification of a product as a high-risk AI system in accordance with Article 6(1) does not affect the choice of conformity assessment procedure provided to those manufacturers, and that those manufacturers are not required to choose a procedure involving third-party conformity assessment only because the product includes a high-risk AI system as a safety component, if that harmonisation legislation does not require it. The fourth subparagraph provides that the provider of a system both covered by that harmonisation legislation and falling within one of the categories listed in Annex III follows the relevant conformity assessment procedure as required pursuant to the relevant Union harmonisation legislation listed in Section A of Annex I.

    • Locator: Article 1, point (19), replacing Article 43(3)praxikon:eu:ai-act:source:reg-eu-2026-1744Open official source

  • Annex I was amended with effect from 27 July 2026: in Section A, point 1 was deleted, and in Section B, point 21 was added, referring to Regulation (EU) 2023/1230 on machinery. Article 2(2), likewise replaced, provides that for AI systems classified as high-risk in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Article 60a and Articles 102 to 112 apply, and that Articles 57, 58 and 59 apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that harmonisation legislation.

    • Locator: Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex Ipraxikon:eu:ai-act:source:reg-eu-2026-1744Open official source

  • Article 36 governs what happens to certificates already issued where the notified body itself is concerned. Paragraph 3 provides that a body deciding to cease its conformity assessment activities shall inform the notifying authority and the providers concerned as soon as possible, and in the case of a planned cessation at least one year beforehand, and that its certificates may remain valid for nine months after the cessation on condition that another notified body has confirmed in writing that it will assume responsibility, that other body carrying out a full assessment before the end of those nine months before issuing new certificates. Paragraph 5 provides that a notified body whose designation is suspended, restricted or withdrawn in whole or in part shall inform the providers concerned within ten days. Paragraph 7 provides that in that case the notifying authority shall assess the impact on the certificates issued, shall require the body to suspend or withdraw within a reasonable period any certificates unduly issued, and shall provide the national competent authorities of the Member State in which the provider has its registered place of business with all relevant information on the certificates whose suspension or withdrawal it has ordered. Paragraph 8, point (b), provides that where the notifying authority establishes that the body is not capable of supporting existing certificates issued, the provider of the system covered by the certificate shall confirm in writing to the national competent authorities of the Member State of its registered place of business, within three months of the suspension or restriction, that another qualified notified body will temporarily assume the monitoring of and responsibility for the certificates. Paragraph 9 provides that upon withdrawal of a designation certificates, with the exception of those unduly issued, remain valid for nine months where the national competent authority has confirmed that there is no risk and another notified body has confirmed in writing that it assumes immediate responsibility and will complete its assessment within twelve months of the withdrawal.

    • Locator: Article 36(3), (5), (7), (8) and (9)praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

  • Article 45(2), point (b), provides that each notified body shall inform the other notified bodies of Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and supplements which it has issued.

  • Point (c) of the third paragraph of Article 113 was replaced with effect from 27 July 2026 and now provides that Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5), applies from 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III, and from 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I. That deferral concerns those three Sections alone. Article 44 sits in Section 5 of Chapter III and therefore falls under the general application date given in the second paragraph of Article 113: 2 August 2026.

    • Locator: Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)praxikon:eu:ai-act:source:reg-eu-2026-1744Open official source
    • Locator: Chapter III, Section 5, and Article 113, second paragraphpraxikon: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.

  • Start with the question whether this Article touches you at all, because for most high-risk systems the answer is no. Of Annex III only the biometrics of point 1 pass through a notified body, and there only where you choose that route yourself or where one of the four cases in the second subparagraph of Article 43(1) arises; points 2 to 8 follow the internal control of Annex VI and produce no certificate whatsoever. Whoever does hold a certificate usually holds it through the regulated products of Annex I, Section A, and that certificate comes out of the sectoral conformity assessment of Article 43(3) rather than out of Annex VII. Check first which Section carries your product, because that shifted on 27 July 2026: machinery was taken out of Section A and placed in Section B as Regulation (EU) 2023/1230, and for Section B products the amended Article 2(2) makes only Article 6(1), Article 60a and Articles 102 to 112 applicable. Article 44 is not among them, so for AI in machinery this Article no longer bears, while it applies in full to the remaining products of Section A. On that Section A route the assessment is moreover wider than it was: since 27 July 2026 the quality management system of Article 17 is assessed as well, and point 3, points 4.3, 4.4 and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII apply. That difference is practical: the language requirement of paragraph 1 is tied to the Annex VII certificate and does not carry over unchanged to that sectoral route, whereas the five years of paragraph 2 simply apply. The mistake the Article exposes is the idea that conformity assessment is a project that ends. The certificate has an end date, at most four years for an Annex III system and at most five for an Annex I product, and the re-assessment that carries the extension itself takes time. Whoever knocks on the door only in the final month stands on the expiry date without valid paper while the system simply runs in production. The clock is moreover not the most frequent reason to go back. Article 43(4) sends a system through the assessment again whenever it is substantially modified, including where you only keep using it internally; only changes you predetermined and recorded in the technical documentation do not count. In practice that trigger arrives years before the expiry date. Where things do go wrong, the response of the body is not binary: the principle of proportionality in paragraph 3 allows it to confine itself to restrictions instead of withdrawal, correcting within the deadline it sets holds off the measure, and an appeal procedure against its decision is available. Count on none of the three as a matter of course, but know that they exist. Nor should you count on starting afresh elsewhere after a refusal: Article 45(2), point (b), obliges the body to inform its peer bodies of certificates refused, withdrawn, suspended or restricted. Also put 28 January 2028 in your diary, even though that date is not addressed to you. The second subparagraph of the new Article 43(3) lets bodies notified only under the sectoral legislation of Annex I, Section A, assess conformity with Section 2, but only where their compliance with Article 31(4), (5), (10) and (11) has already been assessed in their existing notification, and requires those same bodies to apply for designation under Section 4 by that date. The recital accompanying the amendment describes that power as an arrangement for eighteen months from 27 July 2026. So ask your body what its status is and whether it is applying, because who can carry out your assessment after that date depends on it. Finally, watch the side that has nothing to do with your system. A notified body can cease its activities or lose its designation. Article 36 then gives you nine months, but only where another body assumes responsibility in writing, and the body must inform you within ten days. In a suspension where the authority establishes that your body can no longer support the existing certificates, there is even a genuine duty on you: to confirm in writing to your national competent authority, within three months, which other qualified body will temporarily take over the monitoring. That is the only hard deadline in this whole block that lands on your desk.

    • Locator: Article 44(1)-(3)praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source
    • Locator: Article 43(1), (2) and (4)praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source
    • Locator: Article 1, point (19), replacing Article 43(3)praxikon:eu:ai-act:source:reg-eu-2026-1744Open official source
    • Locator: Article 1, point (2)(a), replacing Article 2(2), and point (41), amending Annex Ipraxikon:eu:ai-act:source:reg-eu-2026-1744Open official source
    • Locator: Article 36(3), (5), (7), (8) and (9)praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source
    • Locator: Article 45(2), point (b)praxikon: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.

  • First establish per high-risk system whether there is a certificate at all, and along which route it was issued: Annex VII or the sectoral procedure of Article 43(3). Check while doing so whether your product still sits in Section A of Annex I since 27 July 2026, because for the Section B products, machinery among them, the amended Article 2(2) does not make this Article apply. Then record which certificate belongs to it, which notified body issued it, on what date it expires and which supplements are attached to it, and put that expiry date in the same watch list as your contracts. Plan the extension request well before the expiry date, because the extension rests on a re-assessment in accordance with the applicable conformity assessment procedures. Also tie your change management to Article 43(4): determine per change whether it is substantial, and record the predetermined changes of a learning system in the technical documentation of point 2(f) of Annex IV, because only those do not count as a substantial modification. Designate who receives a message from the notified body, so that a deadline set for corrective action does not expire in a general inbox, and keep the appeal procedure of paragraph 3 open as a route alongside correcting itself. Finally, bring the body itself into the same watch list: track whether it ceases its activities or loses its designation, ask whether it is filing the application for designation under Section 4 that the second subparagraph of Article 43(3) requires of it by 28 January 2028, and make sure you can file the confirmation of Article 36(8), point (b), in writing with your national competent authority within three months.

When this applies

  1. 1Applies as soon as a notified body has issued a certificate for a high-risk AI system. That happens along two routes. The certificate under Annex VII, which under Article 43(1) and (2) arises within Annex III only for the biometrics of point 1. There it can arise along two ways: a provider who has applied harmonised standards or common specifications may under the first subparagraph of paragraph 1 choose between the internal control of Annex VI and the procedure involving a notified body of Annex VII, and the second subparagraph makes Annex VII mandatory in the four cases it lists. And the certificate issued under Article 43(3) as replaced with effect from 27 July 2026, within the sectoral conformity assessment of the products of Annex I, Section A, where the body is notified under that sectoral legislation, where the quality management system of Article 17 is assessed as well, and where point 3, points 4.3, 4.4 and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII apply. For the products of Annex I, Section B, which cover machinery since 27 July 2026, this Article has no bearing: the amended Article 2(2) makes only Article 6(1), Article 60a and Articles 102 to 112 applicable to those systems, and Article 44 is not in that list. Nor does it bear on the systems of points 2 to 8 of Annex III, which under Article 43(2) follow the internal control of Annex VI, where no notified body is involved.

When this does not apply

  • Paragraph 3 withholds suspension, withdrawal or restriction where compliance with the requirements of Section 2 is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The principle of proportionality also allows the body to confine itself to restrictions instead of withdrawal.

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 44: certificates of notified bodies",
praxikon:eu:ai-act:obligation:article-44-notified-body-certificates@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0 (schema 1.5.0),
effective_at 2026-08-02T00:00:00.000Z, known_at 2026-08-14T00:00:00.000Z,
sha256 458f4f14180a115bbccca9bac5e76eae0e9642c92bc0831b57b8e803ebb447b9,
https://www.praxikon.com/en/verkenner/obligation/article-44-notified-body-certificates
(https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-44-notified-body-certificates&effective_at=2026-08-02&known_at=2026-08-14&lang=en, accessed 2026-09-21)

Short form

praxikon:eu:ai-act:obligation:article-44-notified-body-certificates@1.0.0 (sha256 458f4f14)

BibTeX

@misc{praxikon-eu-ai-act-obligation-article-44-notified-body-certificates-1-0-0,
  author       = {{Praxikon}},
  title        = {Article 44: certificates of notified bodies},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:obligation:article-44-notified-body-certificates},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.2.0, schema 1.5.0},
  note         = {effective_at 2026-08-02T00:00:00.000Z; known_at 2026-08-14T00:00:00.000Z; sha256 458f4f14180a115bbccca9bac5e76eae0e9642c92bc0831b57b8e803ebb447b9},
  url          = {https://www.praxikon.com/en/verkenner/obligation/article-44-notified-body-certificates},
  urldate      = {2026-09-21},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:obligation:article-44-notified-body-certificates@1.0.0",
    "type": "dataset",
    "title": "Article 44: certificates of notified bodies",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:obligation:article-44-notified-body-certificates",
    "URL": "https://www.praxikon.com/en/verkenner/obligation/article-44-notified-body-certificates",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          14
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          9,
          21
        ]
      ]
    },
    "note": "dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0; schema 1.5.0; effective_at 2026-08-02T00:00:00.000Z; known_at 2026-08-14T00:00:00.000Z; sha256 458f4f14180a115bbccca9bac5e76eae0e9642c92bc0831b57b8e803ebb447b9; retrieved_from https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-44-notified-body-certificates&effective_at=2026-08-02&known_at=2026-08-14&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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