AI Act Conformity Assessment: Preparing Your Infrastructure for Certification

Before deploying a high-risk AI system, you must complete a conformity assessment demonstrating compliance with all applicable requirements. For most high-risk systems (except biometrics), this is a self-assessment based on internal controls. But "self-assessment" doesn't mean "no evidence" — it means you are the assessor, and you need comprehensive documentation.

Conformity Assessment Process

1. Quality management system — Documented QMS covering AI development lifecycle
2. Technical documentation — Complete documentation per Annex IV
3. Record-keeping — Automatic logging system operational
4. Risk management — Continuous risk management system in place
5. Post-market monitoring — Monitoring plan established
6. Declaration of conformity — Formal declaration signed
7. CE marking — Applied to the AI system
8. EU database registration — System registered before deployment

Infrastructure to Support Conformity

Automated Technical Documentation (Annex IV)

Annex IV specifies what the technical documentation must contain. Automate what you can:

• General system description → Generated from architecture-as-code and API specifications
• Development process description → Extracted from CI/CD pipeline configuration and MLOps metadata
• Monitoring and control → Generated from monitoring configuration and alerting rules
• Risk management → Exported from risk management platform with current risk status
• Data governance → Lineage reports, quality metrics, bias assessments from data pipelines
• Testing and validation → Automated test result aggregation with benchmark comparisons

Continuous Conformity

Conformity isn't a one-time event. Any "substantial modification" to a high-risk AI system requires re-assessment. Your infrastructure must: detect substantial modifications (model retraining, architecture changes, data source changes), trigger re-assessment workflows, and maintain conformity documentation as a living artifact.

EU Database Registration

Article 71 requires registration of high-risk AI systems in an EU database before deployment. Your infrastructure should automate: pre-deployment registration check, registration data preparation, and ongoing updates when system characteristics change.