Obligations register
Start with your role and situation. Every route separates official fact, our interpretation and recommended action and shows source, version and latest review.
Public and no account required. The official source remains authoritative.
Classification route for standalone high-risk AI systems under Article 6(2) and Annex III.
Relevant to: Deployer, Provider of an AI system
First action
Classify the use case and document the outcome
Evidence to retain
Article 6 and Annex III classification record
Quality and governance requirements for training, validation and test data of high-risk AI.
Relevant to: Deployer, Provider of an AI system
The technical file demonstrating before market placement that a high-risk system meets the requirements.
Relevant to: Provider of an AI system
First action
Build the technical file per Annex IV
Evidence to retain
Technical file (Annex IV)
Automatic recording of events over the lifetime of a high-risk AI system.
Relevant to: Deployer, Provider of an AI system
First action
Design logging into the system
Evidence to retain
Logs and retention regime
Comprehensible instructions for use and system information so deployers can operate the system correctly.
Relevant to: Deployer, Provider of an AI system
First action
Provide complete instructions for use
Evidence to retain
Instructions and interpretation file
High-risk AI must be designed so that humans can effectively oversee it and intervene.
Relevant to: Deployer, Provider of an AI system
First action
Design and assign effective human oversight
Evidence to retain
Oversight file per system
Appropriate levels of performance, robustness and security across the lifecycle of high-risk AI.
Relevant to: Provider of an AI system
First action
Set and test performance and security levels
Evidence to retain
Performance and security file
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.
Relevant to: Provider of an AI system
First action
Assign an internal owner and a date to each point of Article 16
Evidence to retain
Provider dossier per high-risk AI system
The documented quality system through which a high-risk AI provider structurally assures compliance.
Relevant to: Provider of an AI system
First action
Set up an AI quality management system
Evidence to retain
QMS documentation
Providers and deployers take measures that support the development of AI literacy.
Relevant to: Deployer, Provider of an AI system
First action
Take role- and context-specific AI literacy measures
Evidence to retain
AI literacy measures record
The prohibition of AI practices carrying unacceptable risk, such as manipulation, social scoring and certain biometric applications.
Relevant to: Deployer, Provider of an AI system
First action
Screen every use case against Article 5 first
Evidence to retain
Article 5 screening record
Specific disclosure, marking and labelling duties for certain AI systems and synthetic content.
Relevant to: Deployer, Provider of an AI system
First action
Implement the applicable disclosure, marking or label
Evidence to retain
Transparency implementation record
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.
Relevant to: Deployer, Provider of an AI system, Body governed by public law
First action
Apply to a sandbox and agree the sandbox plan
Evidence to retain
Written proof of participation and the exit report
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.
Relevant to: Deployer, Provider of an AI system
First action
Submit the testing plan, obtain approval and register the test
Evidence to retain
Dated and documented informed consent of test subjects
Systematic monitoring of high-risk AI in real use, after market placement.
Relevant to: Deployer, Provider of an AI system
First action
Draw up a post-market monitoring plan
Evidence to retain
Monitoring plan and reports
The duty to report serious incidents with high-risk AI, under strict deadlines.
Relevant to: Deployer, Provider of an AI system
First action
Set up an incident process with reporting routes
Evidence to retain
Incident register and reports
A continuous, documented risk management system across the entire lifecycle of a high-risk AI system.
Relevant to: Provider of an AI system
First action
Set up an iterative risk management process
Evidence to retain
Risk management file
The route from assessment to CE marking and EU database registration before market placement of high-risk AI.
Relevant to: Provider of an AI system, Body governed by public law
First action
Complete the conformity route before market placement
Evidence to retain
Conformity file
Role shifts in the AI value chain and the mandatory representative for non-EU providers.
Relevant to: Deployer, Provider of an AI system
First action
Assess the value-chain role per system and change
Evidence to retain
Value-chain file