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Artikel 4Alle systemen

AI Literacy

Providers and deployers must take measures to ensure a sufficient level of AI literacy among their staff and anyone operating AI systems on their behalf, taking into account technical knowledge, experience, and the context of use.

Aanbieder · Gebruiksverantwoordelijke2 februari 2025
Artikel 5Verboden

Prohibited AI practices

Article 5 lists AI practices banned in the Union because they are considered contrary to Union values and fundamental rights. The prohibitions have applied since 2 February 2025.

Aanbieder · Gebruiksverantwoordelijke · Importeur · Distributeur2 februari 2025
Artikel 6Hoog risico

Classification rules for high-risk AI systems

Article 6 sets out when an AI system counts as high-risk: as a safety component of a product covered by Annex I harmonised legislation, or through the use cases listed in Annex III.

Aanbieder2 augustus 2026
Artikel 9Hoog risico

Risk management system

Providers of high-risk AI systems must establish, implement, document, and maintain a risk management system that runs continuously across the whole lifecycle of the system.

Aanbieder2 augustus 2026
Artikel 10Hoog risico

Data and data governance

High-risk AI systems trained with data must be developed on training, validation, and testing datasets that meet defined quality criteria and are subject to appropriate governance practices.

Aanbieder2 augustus 2026
Artikel 11Hoog risico

Technical documentation

Providers must draw up technical documentation before the high-risk AI system is placed on the market and keep it up to date, demonstrating that the system meets the requirements of the Regulation.

Aanbieder2 augustus 2026
Artikel 12Hoog risico

Record-keeping and automatic logging

High-risk AI systems must technically allow the automatic recording of events over their lifetime, so that functioning can be traced and risk situations identified.

Aanbieder2 augustus 2026
Artikel 13Hoog risico

Transparency and information to deployers

High-risk AI systems must be sufficiently transparent for deployers to interpret their output and use them appropriately, and must be accompanied by clear instructions for use.

Aanbieder2 augustus 2026
Artikel 14Hoog risico

Human oversight

High-risk AI systems must be designed so that natural persons can effectively oversee them while in use, with oversight measures built in by the provider and applied by the deployer.

Aanbieder · Gebruiksverantwoordelijke2 augustus 2026
Artikel 15Hoog risico

Accuracy, robustness and cybersecurity

High-risk AI systems must achieve an appropriate level of accuracy, robustness, and cybersecurity and perform consistently in those respects throughout their lifecycle.

Aanbieder2 augustus 2026
Artikel 16Hoog risico

Obligations of providers of high-risk AI systems

Article 16 consolidates what providers of high-risk AI systems must do before and after placing a system on the market.

Aanbieder2 augustus 2026
Artikel 17Hoog risico

Quality management system

Providers of high-risk AI systems must put in place a documented quality management system covering strategy, procedures, and responsibilities for regulatory compliance.

Aanbieder2 augustus 2026
Artikel 23Hoog risico

Obligations of importers

Importers must verify the conformity of a high-risk AI system before placing it on the Union market and must not place it if they consider it non-conforming.

Importeur2 augustus 2026
Artikel 25Hoog risico

Obligations of distributors

Distributors must check that a high-risk AI system carries the required marking and documentation before making it available, and act when it does not.

Distributeur2 augustus 2026
Artikel 26Hoog risico

Obligations of deployers of high-risk AI systems

Deployers of high-risk AI systems must use them in line with the instructions for use and take organisational measures to keep the system under control.

Gebruiksverantwoordelijke2 augustus 2026
Artikel 27Hoog risico

Fundamental rights impact assessment (FRIA)

Certain deployers must carry out an assessment of the impact on fundamental rights before putting a high-risk AI system into use.

Gebruiksverantwoordelijke2 augustus 2026
Artikel 43Hoog risico

Conformity assessment

Before a high-risk AI system is placed on the market, the provider must complete the applicable conformity assessment procedure.

Aanbieder2 augustus 2026
Artikel 47Hoog risico

EU declaration of conformity

The provider must draw up a written, machine-readable EU declaration of conformity for each high-risk AI system and keep it available for ten years.

Aanbieder2 augustus 2026
Artikel 48Hoog risico

CE marking

High-risk AI systems must bear CE marking to indicate conformity with the Regulation, affixed visibly, legibly, and indelibly.

Aanbieder2 augustus 2026
Artikel 49Hoog risico

Registration in the EU database

Providers of high-risk AI systems — and certain deployers that are public authorities — must register in the EU database before placing the system on the market or putting it into use.

Aanbieder · Gebruiksverantwoordelijke2 augustus 2026
Artikel 50Beperkt risicoCruciaal voor verkopers

Transparency obligations for certain AI systems

Article 50 sets transparency duties for AI systems that interact with people or generate synthetic content. It is the provision that matters most for online shops publishing AI-generated or AI-altered product photos, and it applies from 2 August 2026.

Aanbieder · Gebruiksverantwoordelijke2 augustus 2026
Artikel 53AI voor algemene doeleinden

Obligations of providers of GPAI models

Providers of general-purpose AI models must document their model, inform downstream providers, respect copyright, and publish a summary of training content. These duties have applied since 2 August 2025.

Aanbieder2 augustus 2025
Artikel 72Hoog risico

Post-market monitoring

Providers of high-risk AI systems must establish and document a post-market monitoring system proportionate to the nature and risks of the system.

Aanbieder2 augustus 2026
Artikel Annex IVHoog risico

Content of technical documentation

Annex IV lists the minimum information the technical documentation of a high-risk AI system must contain.

Aanbieder2 augustus 2026
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Deze pagina is een begrijpelijke samenvatting ter oriëntatie. Het is geen juridisch advies — de bindende tekst is Verordening (EU) 2024/1689.

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