B9. Substantial Modification Assessment Formal assessment of whether a system change crosses quantitative thresholds, potentially triggering a new conformity assessment cycle. Three possible outcomes: substantial modification (re-assessment required), within acceptable bounds (documented with evidence), or cumulative baseline trigger (full assessment despite sub-threshold individual change). Retained for ten years regardless of outcome. Responsible party: AI System Assessor assesses. AI Governance Lead approves. Legal and Regulatory Advisor provides input for borderline cases. Regulations addressed: Article 3(23) (substantial modification); Articles 43–47 (conformity assessment); Article 12 (record-keeping of changes). Key outputs

• Per-change threshold evaluation with determination
• Cumulative baseline trigger assessment