
The AI Act is a European regulation on artificial intelligence (AI) – the first comprehensive regulation on AI by a major regulator anywhere.
Establish foundational understanding of the EU AI Act scope, definitions, and applicability to the organization's AI systems. Art. 1-4.
Determine whether the organization is subject to the EU AI Act as a provider, deployer, importer, distributor, or product manufacturer.
Identify and document all systems that qualify as 'AI systems' under the EU AI Act definition.
Ensure the organization does not develop, deploy, or use AI systems that are prohibited under Art. 5 of the EU AI Act.
Screen all AI systems against the prohibited practices list in Art. 5 and ensure none are in use.
Implement controls to prevent unauthorized use of biometric identification and emotion recognition AI systems.
Classify AI systems as high-risk or non-high-risk according to Annex III and Art. 6 criteria.
Systematically assess each AI system against Annex III and Art. 6 to determine if it qualifies as high-risk.
Establish and maintain a continuous risk management system for each high-risk AI system per Art. 9.
Implement data governance practices for training, validation, and testing datasets of high-risk AI systems per Art. 10.
Prepare and maintain comprehensive technical documentation for each high-risk AI system per Art. 11 and Annex IV.
Implement automatic logging capabilities for high-risk AI systems to enable post-deployment monitoring per Art. 12.
Ensure high-risk AI systems are transparent and provide adequate instructions for use to deployers per Art. 13.
Design and implement human oversight measures for high-risk AI systems per Art. 14.
Ensure high-risk AI systems achieve appropriate levels of accuracy, robustness, and cybersecurity per Art. 15.
Fulfill all obligations imposed on providers (Art. 16-23) and deployers (Art. 26) of high-risk AI systems.
Implement all provider obligations for high-risk AI systems including quality management, conformity assessment, registration, and post-market monitoring.
Establish and maintain a Quality Management System (QMS) covering the full AI system lifecycle per Art. 17.
Conduct conformity assessments for high-risk AI systems before market placement per Art. 43.
Fulfill all deployer obligations for high-risk AI systems per Art. 26.
Establish a post-market monitoring system for high-risk AI systems per Art. 72.
Establish incident reporting processes to notify competent authorities of serious incidents per Art. 73.
Comply with obligations for providers of General Purpose AI models and systems under Art. 51-56.
Determine whether the organization develops or fine-tunes models that qualify as General Purpose AI (GPAI) models.
Fulfill all GPAI model provider obligations including technical documentation, copyright policy, and downstream provider information per Art. 53.
Implement additional controls for GPAI models with systemic risk per Art. 55.
Fulfill transparency obligations for limited-risk AI systems including chatbots, deepfakes, and emotion recognition per Art. 50.
Implement disclosure mechanisms for AI-generated or AI-manipulated content and AI interaction systems per Art. 50.
Ensure users are meaningfully informed when interacting with AI systems in contexts that could affect their decisions or rights.
Understand and engage with the EU AI Act governance structure including national authorities, the EU AI Office, and the AI Board.
Identify the relevant national competent authority(ies) and understand notification and cooperation obligations.
Evaluate participation in AI regulatory sandboxes to test innovative AI systems under regulatory supervision per Art. 57-63.
Register high-risk AI systems in the EU AI public database per Art. 71 and maintain accurate registration information.
Register all applicable high-risk AI systems in the EU AI public database before market placement per Art. 71.
Understand enforcement mechanisms, penalty structures, and implement compliance monitoring to avoid infringements.
Understand the penalty structure and implement ongoing compliance monitoring to prevent and detect infringements.
Establish a formal internal AI compliance program with clear ownership, processes, and reporting.
Engage with EU AI Act codes of practice, harmonized standards, and common specifications to demonstrate compliance.
Monitor and adopt relevant harmonized standards to benefit from the presumption of conformity.
Participate in or adopt relevant codes of practice developed under Art. 95 for GPAI models and other AI domains.