High-risk systems (whether Annex III or Annex I) bear the full obligation set under the AI Act. A complete AISDP covering all 12 modules as specified by Article 11 and Annex IV. A conformity assessment under Annex VI (internal control, the default for most Annex III systems) or Annex VII (involving a notified body, required for real-time remote biometric identification and certain Annex I products).

A CE marking affixed to the system or its documentation under Article 48, signifying conformity. Registration in the EU database under Article 49, providing public transparency regarding the system’s existence and key characteristics. A Declaration of Conformity under Article 47 and Annex V, constituting the provider’s legally binding statement of compliance.

The full obligation set also includes post-market monitoring under Article 72, serious incident reporting under Article 73, and quality management system requirements under Article 17. The risk assessment documents this obligation set and confirms that the AISDP is structured to satisfy each element.

Key outputs

• Full 12-module AISDP requirement confirmation
• Conformity assessment route determination (Annex VI or VII)
• CE marking, EU database registration, and Declaration of Conformity planning
• Module 6 AISDP documentation