{"slug":"conformity-assessment-and-registration","id":"AIPT-CTL-0010","title":"Conformity assessment, declaration and registration","kind":"process","kind_label":"Process","purpose":"Takes a regulated system through the applicable pre-market assessment, produces the signed declaration or certificate and completes any registration with authorities before the system is placed on the market.\n","description":"Early in the project the compliance lead determines which assessment route applies, whether an outside body must be involved and what registrations follow, and books notified-body capacity if needed. A conformity checklist maps each legal requirement to the evidence in the technical file, and a gap review is completed before the assessment is formally started. On a successful outcome the declaration is signed by an authorised person, markings are applied, registrations are filed and the records are retained for the required period. A re-assessment trigger list defines which changes require the exercise to be repeated.\n","owner_role":"Regulatory compliance lead","frequency":"per_system","frequency_label":"Once per AI system","risk_subdomains":["6.5","7.3"],"evidence":[{"type":"conformity_declaration","title":"Declaration of conformity or certificate","description":null},{"type":"regulatory_filing","title":"Registration record in the relevant database","description":null},{"type":"technical_file","title":"Conformity evidence pack","description":"Requirement-to-evidence map with the supporting documents."}],"framework_references":[{"framework":"iso_42001","framework_name":"ISO/IEC 42001:2023","reference":"Clause 9.2; Annex A.6.2.7","note":null,"confidence_level":"medium"},{"framework":"nist_ai_rmf","framework_name":"NIST AI RMF 1.0","reference":"GOVERN 1.1; MAP 4.1","note":null,"confidence_level":"low"}],"obligations":[{"slug":"eu-ai-act-importer-distributor-obligations","title":"Verify conformity before importing or distributing high-risk AI","relationship":"supports","note":"Knowledge of the assessment route needed to verify it.","confidence_level":"low","is_binding":true,"policy":"eu-ai-act","jurisdiction":"eu","url":"https://aipolicytracker.org/obligations/eu-ai-act-importer-distributor-obligations"},{"slug":"eu-ai-act-art-22-authorised-representative","title":"Non-EU providers must appoint an EU authorised representative for high-risk AI","relationship":"supports","note":"Items the representative must verify.","confidence_level":"medium","is_binding":true,"policy":"eu-ai-act","jurisdiction":"eu","url":"https://aipolicytracker.org/obligations/eu-ai-act-art-22-authorised-representative"},{"slug":"eu-ai-act-conformity-assessment-registration","title":"Complete conformity assessment, CE marking and EU database registration","relationship":"satisfies","note":"Covers route selection, declaration, marking and database registration.","confidence_level":"high","is_binding":true,"policy":"eu-ai-act","jurisdiction":"eu","url":"https://aipolicytracker.org/obligations/eu-ai-act-conformity-assessment-registration"},{"slug":"eu-ai-act-art-6-4-non-high-risk-assessment-documentation","title":"Providers must document and register a conclusion that an Annex III system is not high-risk","relationship":"supports","note":"Registration under Article 49(2).","confidence_level":"high","is_binding":true,"policy":"eu-ai-act","jurisdiction":"eu","url":"https://aipolicytracker.org/obligations/eu-ai-act-art-6-4-non-high-risk-assessment-documentation"}],"related_controls":["technical-documentation-and-model-cards","ai-quality-management-system","accuracy-robustness-security-testing","model-release-and-change-management-gate"],"review_status":"verified","confidence_level":"medium","last_verified_at":"2026-09-26","reviewed_by":"Bhaskar Bhatt","updated_at":"2026-10-15T06:46:22+00:00","url":"https://aipolicytracker.org/controls/conformity-assessment-and-registration","context_url":"https://aipolicytracker.org/controls/conformity-assessment-and-registration.md"}