Practical requirements extracted from policy instruments, with the source article, the actors they bind, evidence examples and original framework mappings. Legal requirements are marked; everything else is voluntary guidance.
High-risk AI systems must achieve an appropriate level of accuracy, robustness and cybersecurity and perform consistently throughout their lifecycle. Accuracy levels and metrics must be declared in the instructions; systems must be resilient to errors, faults and inconsistencies, address feedback loops in continuously learning systems, and resist attempts to alter use or performance, including data poisoning, model poisoning, adversarial examples and confidentiality attacks.
Pending review (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Legal requirementConformity assessment and registration·European Union
EU AI Act · Articles 43, 47, 48 and 49; Annex VIII
Before placing a high-risk system on the market, providers must complete the applicable conformity assessment (internal control or notified-body assessment depending on the system), draw up an EU declaration of conformity, affix the CE marking, and register the system in the EU database. Deployers that are public authorities must also register their use of Annex III systems.
Pending review (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Legal requirementGovernance and accountability·European Union
A distributor, importer, deployer or other third party is treated as the provider of a high-risk AI system, with all Article 16 duties, if it puts its own name or trademark on a system already on the market, makes a substantial modification to a high-risk system that stays high-risk, or changes the intended purpose of a system so that it becomes high-risk. The original provider then ceases to be provider for that system but must cooperate and supply the information and access needed for the new provider to comply.
Verified (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Legal requirementGovernance and accountability·European Union
Before making a high-risk AI system available in the Union, a provider established outside the EU must appoint, by written mandate, an authorised representative established in the Union. The representative verifies that the EU declaration of conformity and technical documentation exist and that conformity assessment was done, keeps the provider's contact details and the documentation available for ten years, supplies information to authorities, cooperates with them, and must end the mandate if the provider acts contrary to the Regulation.
Verified (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Legal requirementGovernance and accountability·European Union
Article 16 lists what a provider of a high-risk AI system owes: compliance with the Section 2 requirements, its name and contact details on the system or its documentation, a quality management system, retention of documentation and logs, conformity assessment, an EU declaration of conformity, CE marking, registration, corrective action when needed, cooperation with authorities on request, and accessibility in line with the EU accessibility directives.
Verified (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Legal requirementGovernance and accountability·European Union
On a reasoned request from a national competent authority, a provider of a high-risk AI system must supply all the information and documentation needed to show that the system meets the Section 2 requirements, in a language the authority can readily understand, and must give the authority access to the automatically generated logs it holds. Authorities must treat what they receive as confidential under Article 78.
Verified (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Operators of high-impact AI must ensure that the AI is subject to human management and supervision, so that people remain able to monitor its operation and intervene in or override its outputs where those outputs may affect life, physical safety or fundamental rights.
Verified (a factual check against the official source, not a legal review)Applies from 22 Jan 2026
Legal requirementIncident reporting and handling·European Union
A provider that considers, or has reason to consider, that a high-risk system it has placed on the market is not in conformity must immediately correct it, withdraw it, disable it or recall it as appropriate, and inform the distributors, deployers, authorised representative and importers. Where the system presents a risk to health, safety or fundamental rights and the provider becomes aware of that risk, it must immediately investigate the causes together with the reporting deployer and inform the market surveillance authorities and, where relevant, the notified body.
Verified (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Legal requirementIncident reporting and handling·European Union
Providers of high-risk AI systems must report serious incidents to the market-surveillance authority of the Member State where the incident occurred, immediately after establishing a causal link (or reasonable likelihood) and no later than 15 days after becoming aware, with shorter limits for the most serious cases such as widespread infringements or death. Deployers must inform the provider and authorities when they identify a serious incident.
Pending review (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Deployers must monitor a high-risk AI system's operation against the provider's instructions and feed observations to the provider under Article 72. If they have reason to think the system as used may present a risk to health, safety or fundamental rights, they must inform the provider or distributor and the market surveillance authority without undue delay and suspend use. On a serious incident, they must immediately inform the provider, then the importer or distributor and the authorities. Financial institutions meet this through their internal governance rules.
Verified (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Providers must establish and document a post-market monitoring system proportionate to the nature of the AI technology and its risks, actively and systematically collecting and analysing performance data throughout the system's lifetime, based on a monitoring plan that is part of the technical documentation. The Commission is to adopt a template for the plan.
Pending review (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Legal requirementQuality management system·European Union
Providers of high-risk AI systems must put in place a documented quality management system covering regulatory-compliance strategy, design and development procedures, testing and validation, technical specifications and standards, data management, the risk-management system, post-market monitoring, incident reporting, communication with authorities, record keeping, resource management and an accountability framework.
Pending review (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Legal requirementRecord keeping and logging·European Union
For ten years after a high-risk AI system is placed on the market or put into service, the provider must keep at the disposal of national competent authorities the technical documentation, the quality management system documentation, any changes approved by a notified body, the notified body's decisions and other documents, and the EU declaration of conformity. Financial institutions keep these as part of their sector record-keeping.
Verified (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Legal requirementRecord keeping and logging·European Union
Providers must keep the event logs that a high-risk AI system generates under Article 12, to the extent those logs are within their control, for a period appropriate to the system's intended purpose and in any case for at least six months, unless Union or national law on personal data sets a different period. Financial institutions keep the logs under their sector rules.
Verified (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Providers of high-risk AI systems must establish, implement, document and maintain a continuous, iterative risk-management system across the system's lifecycle: identifying known and reasonably foreseeable risks to health, safety and fundamental rights, estimating and evaluating risks including from reasonably foreseeable misuse, evaluating post-market data, and adopting targeted risk-management measures, with testing before placing on the market.
Pending review (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
An AI business operator that provides high-impact AI, or a product or service using it, must establish and operate a plan for managing the risks of that AI. High-impact AI is AI used in areas such as energy, drinking water, health care and medical devices, nuclear safety, biometric analysis for criminal investigation, decisions on recruitment or loans, transport, public services and education, where it may materially affect life, safety or fundamental rights.
Verified (a factual check against the official source, not a legal review)Applies from 22 Jan 2026
Technical documentation must be drawn up before a high-risk system is placed on the market or put into service and kept up to date. It must demonstrate compliance with the Section 2 requirements and contain at least the elements in Annex IV, including a general description, development process, monitoring and control, risk-management description, and the applied standards. SMEs may use a simplified form provided by the Commission.
Pending review (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Legal requirementVendor and supply-chain governance·European Union
A provider of a high-risk AI system and any third party that supplies AI systems, tools, services, components or processes used in or integrated into it must set out, in a written agreement, the information, capabilities, technical access and other assistance needed for the provider to meet its obligations, based on the generally acknowledged state of the art. Suppliers of free and open-source tools and components other than general-purpose AI models are outside this duty. The AI Office may publish voluntary model terms.
Verified (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Legal requirementVendor and supply-chain governance·European Union
Importers must verify that the provider completed conformity assessment, drew up technical documentation, affixed CE marking and appointed an authorised representative where required, and must indicate their name and contact details on the system. Distributors must verify CE marking, the declaration of conformity and instructions, and refrain from making non-compliant systems available.
Pending review (a factual check against the official source, not a legal review)Applies from 2 Dec 2027
Regulators are asked to ensure AI systems function in a robust, secure and safe way, with risks continually identified, assessed and managed. In practice this is enforced through existing safety, security and data-protection law rather than a new duty.
Source-linked (a factual check against the official source, not a legal review)
Voluntary guidanceSafety testing and evaluation·United States
Measure covers selecting metrics and test methods, evaluating validity, safety, security, resilience, explainability, privacy, fairness and bias, and monitoring these over time, including through independent review and red-teaming for generative AI.
Source-linked (a factual check against the official source, not a legal review)
A single practical requirement pulled out of an instrument and stated on its own: keep a risk management system, log incidents, document training data, provide human oversight, and so on. Each one cites the article or section it comes from so you can check it against the source.
Does a voluntary obligation have legal force?
No, and every obligation is labelled either a legal requirement or voluntary guidance. Voluntary items still matter in practice, because procurement questionnaires and auditors ask about them, but only the binding ones carry legal consequence.
How do I find the obligations that apply to my organisation?
Filter by jurisdiction, category, actor, sector or use case. The applicability check asks a short set of questions and returns the duties that may reach you. It is an educational screen, not a legal determination, and it says so.
Why do some instruments have no obligations listed?
Because nobody has broken them out yet. Most instruments are recorded at summary level first; obligations are added jurisdiction by jurisdiction. The coverage and open-gaps pages publish exactly what is missing rather than hiding it.
