{"slug":"eu-ai-act-conformity-assessment-registration","id":"AIPT-OBL-0014","permanent_url":"https://aipolicytracker.org/id/AIPT-OBL-0014","title":"Complete conformity assessment, CE marking and EU database registration","short_title":"Conformity assessment and registration","category":"conformity_assessment","summary":"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.\n","practical_action":"Determine the assessment route early; notified-body capacity may be limited around application dates.\n","is_binding":true,"applies_from":"2027-12-02","section":"Articles 16–27","source_reference":"Articles 43, 47, 48 and 49; Annex VIII","official_source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","review_status":"pending_review","confidence_level":"medium","last_verified_at":null,"reviewed_by":null,"actors":["provider","deployer","public_authority"],"sectors":["cross_sector"],"use_cases":["biometrics","public_services","safety_critical"],"applicability":[{"description":"Providers of high-risk systems; public-authority deployers for registration.","actors":["provider","public_authority"],"conditions":null}],"evidence_examples":[{"title":"EU declaration of conformity","description":null,"artifact_type":"document"},{"title":"EU database registration record","description":null,"artifact_type":"record"}],"framework_mappings":[{"framework":"iso_42001","framework_name":"ISO/IEC 42001:2023","reference":"Clause 9 Performance evaluation; internal audit","note":"Original editorial mapping; not a substitute for legal conformity assessment.","confidence_level":"low","is_original":true}],"controls":[{"slug":"conformity-assessment-and-registration","title":"Conformity assessment, declaration and registration","kind":"process","relationship":"satisfies","note":"Covers route selection, declaration, marking and database registration.","confidence_level":"high","url":"https://aipolicytracker.org/controls/conformity-assessment-and-registration"},{"slug":"ai-quality-management-system","title":"Quality management system for AI development and supply","kind":"policy","relationship":"supports","note":"Internal-control assessment relies on the documented management system.","confidence_level":"medium","url":"https://aipolicytracker.org/controls/ai-quality-management-system"},{"slug":"technical-documentation-and-model-cards","title":"Technical documentation, model cards and instructions for use","kind":"process","relationship":"supports","note":"The technical file is the input to the assessment.","confidence_level":"high","url":"https://aipolicytracker.org/controls/technical-documentation-and-model-cards"}],"url":"https://aipolicytracker.org/obligations/eu-ai-act-conformity-assessment-registration","policy":{"slug":"eu-ai-act","title":"Regulation (EU) 2024/1689 — Artificial Intelligence Act","status":"partially_applicable","jurisdiction":"eu","url":"https://aipolicytracker.org/policies/eu-ai-act"}}