Objetivo
Ensure AI systems classified as high risk are properly documented and registered with EU authorities (and other jurisdictions where required) before market placement or deployment.
Alcance
Applies to all high-risk AI systems under EU AI Act Annex III and any other regulatory regime requiring system registration or notification.
- Employment, credit, education, healthcare, law enforcement, critical infrastructure AI
- Any AI system flagged high-risk by internal risk assessment even if not in Annex III
Definiciones
- High-Risk Classification Checklist: Tool mapping AI use cases to Annex III categories and internal criteria.
- Registration Dossier: Evidence package submitted to authorities, including technical documentation, risk assessments, and conformity declarations.
- Authorized Representative: Local EU representative for organizations outside the Union.
Política
Compliance Program Manager must confirm classification, prepare the registration dossier, and submit required documentation via the EU database (and other regulators) before deployment. Registrations must be kept current when system changes occur.
Roles y responsabilidades
Compliance Program Manager leads the registration workflow. Model Owner supplies technical documentation. Legal ensures authorized representative arrangements. Responsible AI confirms risk controls align with Annex IV requirements.
Procedimientos
Registration workflow includes:
- Classify model using the high-risk checklist and document rationale.
- Compile registration dossier (technical documentation, risk management, CE declarations).
- Coordinate with authorized representative if required.
- Submit dossier to the EU database and capture acknowledgement.
- Update registration upon major changes or decommissioning.
- Maintain evidence of communication with authorities.
Excepciones
No exceptions for systems operating in regulated markets. Experimental deployments must remain isolated until registration is complete.
Frecuencia de revisión
Registration status is reviewed quarterly; any discrepancies trigger remediation within 15 business days.
Referencias
- EU AI Act Articles 49-52 (Registration of high-risk AI systems)
- Internal documents: High-Risk Classification Checklist, Registration Dossier Template, Regulator Communication SOP