Why this object hangs off that object

High-risk AI systems placed on the market or put into service before the date of application of Chapter III, since the Digital Omnibus 2 December 2027 for Annex III systems and 2 August 2028 for Annex I systems, come under the high-risk requirements of that Chapter only once their design is significantly changed as from that date. This is not an exemption from the whole Regulation: Article 4 and Article 50 keep running. For systems intended to be used by public authorities the carve out falls away entirely: their providers and deployers must in any case comply with the requirements and obligations by 2 August 2030.

Placed against the official source | high-risk, timeline

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

Article 4a grants permission rather than instruction, and to two different sets of parties. Paragraph 1 allows only the provider of a high-risk AI system to process special categories of personal data by way of exception, to the extent strictly necessary for bias detection and correction within the meaning of Article 10(2), points (f) and (g), and only where all six conditions (a) to (f) are met. Paragraph 2 opens the same room to providers and deployers of other AI systems and models and to deployers of high-risk systems, but only for bias likely to affect the health and safety of persons, to have a negative impact on fundamental rights or to lead to discrimination prohibited under Union law, and subject to the same six conditions. Until 27 July 2026 this basis sat in Article 10(5).

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

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

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