§ EU AI Act · Article 43

AI Act Article 43: Obligations, Deadlines & Penalties

Regulation (EU) 2024/1689, Article 43 · All obligations · EU AI Act · Full article analysis
At a glance
Article 43 of the AI Act imposes 10 obligations on Commission, manufacturer, market surveillance authority and 2 other entity type(s).
§ Obligations

All obligations under Article 43

Obligation 1
Providers of high-risk AI systems listed in point 1 of Annex III who have applied harmonised standards or common specifications must opt for either internal control or assessment involving a notified body. Regulation (EU) 2024/1689, Article 43, Article 43
Obligated entity
provider
Sector scope
high-risk AI systems (Annex III point 1)
Action required
opt
Deadline
Penalty
Obligation 2
Providers must follow the conformity assessment procedure set out in Annex VII involving a notified body if harmonised standards do not exist, are not applied, or are applied only partially. Regulation (EU) 2024/1689, Article 43, Article 43
Obligated entity
provider
Sector scope
high-risk AI systems (Annex III point 1)
Action required
follow
Deadline
Penalty
Obligation 3
Where a high-risk AI system is intended for law enforcement, immigration, asylum authorities, or Union institutions, the market surveillance authority shall act as the notified body. Regulation (EU) 2024/1689, Article 43, Article 43
Obligated entity
market surveillance authority
Sector scope
law enforcement, immigration, asylum, Union institutions
Action required
act as
Deadline
Penalty
Obligation 4
Providers of high-risk AI systems referred to in points 2 to 8 of Annex III shall follow the conformity assessment procedure based on internal control as referred to in Annex VI. Regulation (EU) 2024/1689, Article 43, Article 43
Obligated entity
provider
Sector scope
high-risk AI systems (Annex III points 2-8)
Action required
follow
Deadline
Penalty
Obligation 5
For high-risk AI systems covered by Union harmonisation legislation in Section A of Annex I, the provider shall follow the relevant conformity assessment procedure required under those legal acts. Regulation (EU) 2024/1689, Article 43, Article 43
Obligated entity
provider
Sector scope
high-risk AI systems covered by Union harmonisation legislation
Action required
follow
Deadline
Penalty
Obligation 6
Notified bodies notified under Union harmonisation legislation shall be entitled to control the conformity of high-risk AI systems with Section 2 requirements, provided their compliance with Article 31 requirements has been assessed. Regulation (EU) 2024/1689, Article 43, Article 43
Obligated entity
notified body
Sector scope
high-risk AI systems covered by Union harmonisation legislation
Action required
control
Deadline
Penalty
Obligation 7
A manufacturer may opt out from third-party conformity assessment only if they have applied harmonised standards or common specifications covering all requirements set out in Section 2 of this Chapter. Regulation (EU) 2024/1689, Article 43, Article 43
Obligated entity
manufacturer
Sector scope
high-risk AI systems covered by Union harmonisation legislation
Action required
apply
Deadline
Penalty
Obligation 8
High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new conformity assessment procedure in the event of a substantial modification. Regulation (EU) 2024/1689, Article 43, Article 43
Obligated entity
provider
Sector scope
high-risk AI systems
Action required
undergo
Deadline
Penalty
Obligation 9
The Commission is empowered to adopt delegated acts to amend Annexes VI and VII by updating them in light of technical progress. Regulation (EU) 2024/1689, Article 43, Article 43
Obligated entity
Commission
Action required
adopt
Deadline
Penalty
Obligation 10
The Commission is empowered to adopt delegated acts to amend paragraphs 1 and 2 to subject high-risk AI systems in points 2 to 8 of Annex III to the conformity assessment procedure referred to in Annex VII. Regulation (EU) 2024/1689, Article 43, Article 43
Obligated entity
Commission
Sector scope
high-risk AI systems (Annex III points 2-8)
Action required
adopt
Deadline
Penalty
§ Deadlines

EU AI Act compliance deadlines

§ Frequently asked

Questions about Article 43

Who must comply with Article 43 of the AI Act? +
Commission, manufacturer, market surveillance authority, notified body, provider.
What does Article 43 of the AI Act require? +
opt follow act as
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