AI Act Article 11: Obligations, Deadlines & Penalties

All obligations under Article 11

Obligation 1

The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date. Regulation (EU) 2024/1689, Article 11, Article 11

Obligated entity

provider

Action required

document

Deadline

before placing on the market or putting into service

Penalty

—

Obligation 2

The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. Regulation (EU) 2024/1689, Article 11, Article 11

Obligated entity

provider

Action required

document

Deadline

—

Penalty

—

Obligation 3

The technical documentation shall contain, at a minimum, the elements set out in Annex IV. Regulation (EU) 2024/1689, Article 11, Article 11

Obligated entity

provider

Action required

document

Deadline

—

Penalty

—

Obligation 4

SMEs, including start-ups, may provide the elements of the technical documentation specified in Annex IV in a simplified manner using the form established by the Commission. Regulation (EU) 2024/1689, Article 11, Article 11

Obligated entity

provider

Size threshold

SMEs, including start-ups

Action required

document

Deadline

—

Penalty

—

Obligation 5

Notified bodies shall accept the simplified technical documentation form for the purposes of the conformity assessment when used by SMEs or start-ups. Regulation (EU) 2024/1689, Article 11, Article 11

Obligated entity

notified body

Action required

accept

Deadline

—

Penalty

—

Obligation 6

Where a high-risk AI system related to a product covered by Union harmonisation legislation is placed on the market or put into service, a single set of technical documentation shall be drawn up containing all the information set out in paragraph 1, as well as the information required under those legal acts. Regulation (EU) 2024/1689, Article 11, Article 11

Obligated entity

provider

Sector scope

products covered by Union harmonisation legislation listed in Section A of Annex I

Action required

document

Deadline

—

Penalty

—

EU AI Act compliance deadlines

• 2025-02-02 Article 5 prohibitions (unacceptable risk) in_force
• 2025-02-02 Article 4 AI literacy in_force
• 2025-08-02 GPAI model obligations (Articles 51 to 56) in_force
• 2026-07-27 Regulation (EU) 2026/1744 (Digital Omnibus on AI) enters into force — AI Act applies as amended in_force
• 2026-08-02 AI Act general date of application (Art 113) — governance, penalties and remaining provisions without a different date in_force
• 2026-08-02 Article 50 transparency obligations (AI-interaction disclosure, labelling of deepfakes and AI-generated text, emotion-recognition notices) in_force
• 2026-12-02 Article 50(2) machine-readable marking of AI-generated content — transition for generative AI systems placed on the market before 2 August 2026 scheduled
• 2026-12-02 NEW Article 5 prohibition: AI generation of non-consensual intimate imagery (NCII) and CSAM scheduled
• 2027-08-02 National AI regulatory sandboxes: at least one operational per Member State (Art 57(1)) scheduled
• 2027-12-02 Annex III stand-alone high-risk obligations scheduled
• 2028-08-02 Annex I embedded (regulated-product) high-risk obligations scheduled

Questions about Article 11

Who must comply with Article 11 of the AI Act? +

notified body, provider.

What does Article 11 of the AI Act require? +

document accept

What is the compliance deadline for AI Act Article 11? +

before placing on the market or putting into service