ce-marking-generator

CE marking for AI systems requires conformity declarations and technical documentation per Article 48 of the EU AI Act. This Skill assists by generating those documents and tracking marking requirements through assessment, implementation, and monitoring phases.

Article 48 of the EU AI Act establishes documentation requirements for CE marking AI systems. It mandates generating conformity declarations, compiling technical documentation, and tracking marking requirements through assessment, implementation, documentation, and monitoring phases.

Yes, AI-powered medical devices require CE marking documentation before market entry. You must generate conformity declarations and compile technical documentation to satisfy Article 48 requirements and ensure regulatory compliance.

Assess AI system compliance by evaluating your system against Article 48 requirements. This involves implementing risk mitigation controls, generating conformity declarations, and tracking marking requirements through assessment, implementation, documentation, and monitoring phases.

Yes, CE marking requirement tracking is supported through the monitoring phase. The Skill addresses regulatory context across assessment, implementation, documentation, and monitoring phases to help maintain ongoing AI compliance per Article 48.