Why this object hangs off that object

Classification route for standalone high-risk AI systems under Article 6(2) and Annex III.

Placed against the official source | high-risk

Quality and governance requirements for training, validation and test data of high-risk AI.

Placed against the official source | high-risk-requirements

The technical file demonstrating before market placement that a high-risk system meets the requirements.

Placed against the official source | high-risk-requirements

Automatic recording of events over the lifetime of a high-risk AI system.

Placed against the official source | high-risk-requirements

Comprehensible instructions for use and system information so deployers can operate the system correctly.

Placed against the official source | high-risk-requirements

High-risk AI must be designed so that humans can effectively oversee it and intervene.

Placed against the official source | high-risk-requirements

Appropriate levels of performance, robustness and security across the lifecycle of high-risk AI.

Placed against the official source | high-risk-requirements

Article 16 is the summary list of duties for providers: twelve points that route onward to the quality management system, the documentation, the logs, the conformity assessment, the EU declaration of conformity, the CE marking, the registration, corrective actions and accessibility requirements.

Placed against the official source | high-risk-requirements

The documented quality system through which a high-risk AI provider structurally assures compliance.

Placed against the official source | high-risk-requirements

Before placing a system on the market the importer verifies four things about the provider, and afterwards carries its own retention, information and notification package with a ten-year term.

Placed against the official source | value-chain

Before making a system available on the market the distributor verifies the marking, the declaration and the instructions for use plus compliance by provider and importer, and must afterwards be able to correct, withdraw or recall.

Placed against the official source | value-chain

Twelve paragraphs governing day-to-day use: use in line with the instructions, human oversight by competent people, input data, monitoring and notification, log retention, informing workers before deployment, registration by public authorities and informing the people about whom decisions are made.

Placed against the official source | high-risk-requirements

Fundamental rights impact assessment before deploying certain high-risk AI systems.

Placed against the official source | fundamental-rights, high-risk

Providers and deployers take measures that support the development of AI literacy.

Placed against the official source | ai-literacy

The prohibition of AI practices carrying unacceptable risk, such as manipulation, social scoring and certain biometric applications.

Placed against the official source | prohibited-practices

Specific disclosure, marking and labelling duties for certain AI systems and synthetic content.

Placed against the official source | transparency

Documentation, information, copyright and transparency duties for providers of general-purpose AI models.

Placed against the official source | gpai

Additional duties for the most capable general-purpose AI models, on top of Article 53.

Placed against the official source | gpai-systemic-risk

Member States must provide at least one national AI regulatory sandbox. For you this is a voluntary route: you develop, train, test and validate an innovative AI system in a controlled, supervised environment under a plan agreed with the competent authority, before placing it on the market or putting it into service.

Placed against the official source | innovation

If you want to test an Annex III high-risk AI system with real people and real outcomes before placing it on the market, a full regime applies: a plan, prior approval by the market surveillance authority, registration, informed consent and a maximum duration.

Placed against the official source | innovation

Systematic monitoring of high-risk AI in real use, after market placement.

Placed against the official source | post-market

The duty to report serious incidents with high-risk AI, under strict deadlines.

Placed against the official source | post-market

Anyone with grounds to consider that the Regulation has been infringed may lodge a complaint with the relevant market surveillance authority. For an organisation that means your own staff, customers and candidates have a route to the regulator that does not run through you.

Placed against the official source | fundamental-rights

A person affected by a decision that a deployer takes on the basis of the output of a high-risk AI system listed in Annex III may request an explanation of the role of that system in the decision-making procedure and of the main elements of the decision taken.

Placed against the official source | fundamental-rights

A continuous, documented risk management system across the entire lifecycle of a high-risk AI system.

Placed against the official source | high-risk-requirements

The route from assessment to CE marking and EU database registration before market placement of high-risk AI.

Placed against the official source | conformity

Role shifts in the AI value chain and the mandatory representative for non-EU providers.

Placed against the official source | value-chain