Certification, standards, and legal obligations intersect to define the compliance pathway for high-risk AI systems. The harmonised standards landscape covers the CEN/CENELEC JTC 21 programme, interim reference standards, the presumption of conformity under Article 40, and the re-mapping exercise required when new standards are published.

CE marking documents the affixation requirements and the relationship between the marking and the underlying conformity assessment. The declaration of conformity specifies the document content requirements, maintenance obligations, and multilingual provisions. Liability and insurance addresses the AI Liability Directive interaction, product liability under the revised PLD, insurance requirements, and deployer liability. Assessment failure pathways defines the remediation workflow when conformity assessment identifies non-conformities that cannot be resolved before the intended market placement date.

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This section corresponds to the Certification, Standards & Legal section and feeds primarily into AISDP Module 11 (Certification and Legal).