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Article 43(3)

CurrentFrom 2 Aug 2026

Apply for AI Act Designation by 28 January 2028 When Relying on an Existing Annex I Section A Notification

Applies to Notified Body already notified under Annex I Section A legislation and relying on the Article 43(3) transitional assessment route.

Actors
Notified Body
AI class
Annex I Section A High-Risk AIHigh-Risk AI
Context
EU Market Access
Themes
Risk & AssuranceMonitoring, Reporting & Improvement

Tracker Guidance

If your organization is a notified body already notified under Union harmonisation legislation listed in Annex I Section A and relies on Article 43(3) to assess high-risk AI systems under that existing notification, apply for designation under Chapter III Section 4 of the AI Act by 28 January 2028. The transitional assessment power also depends on the notified body's compliance with Article 31(4), (5), (10) and (11) having been assessed and evidenced through the existing sectoral notification.

Official text

Article 43(3)Official source
3. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider of the system shall follow the relevant conformity assessment procedure as required in accordance with the relevant Union harmonisation legislation. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Assessment of the quality management system set out in Article 17 shall also be undertaken, and points 3, 4.3, 4.4. and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII shall apply. For the purposes of that conformity assessment, notified bodies which have been notified under the Union harmonisation legislation listed in Section A of Annex I shall have the power to assess the conformity of high-risk AI systems with the requirements set out in Section 2 of this Chapter, provided that the compliance of those notified bodies with the requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure in accordance with the relevant Union harmonisation legislation, which is evidenced through the assessment as part of the existing notification. Without prejudice to Article 28, such notified bodies which have been notified under the Union harmonisation legislation in Section A of Annex I, shall apply for designation in accordance with Section 4 of this Chapter by 28 January 2028. [Excerpt - see official source for complete provision]

Excerpt stored at a complete legal-unit boundary. See the official source for the full provision.

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Article 43(3): Apply for AI Act Designation by 28 January 2028 When Relying on an Existing Annex I Section A Notification | EU AI Act Library