The EU AI Act introduces a risk-based regulatory framework for AI governance and mandates conformity assessments for high-risk AI systems. Providers may choose between internal or external assessment, but external assessment is mandatory under certain conditions. Conformity assessments must be combined with other obligations, such as issuance of a certificate, declaration of conformity, CE marking, and registration in the EU database. If a high-risk AI system becomes non-compliant after marketing, corrective actions must be taken. Delegated acts may be introduced by the Commission for conformity assessments. Holistic AI can help enterprises adapt and comply with AI regulation.

The EU AI Act will soon come into effect, and it is important for entities to understand whether they are within the scope of the law and how it applies to them. The first step is to determine if their AI system falls under the definitions and prohibitions given under the Act. They must also determine their role in the market, their geographical scope, and take note of the key enforcement dates. Compliance is crucial as non-compliance may result in harsh penalties. Holistic AI's expert team can support businesses in achieving compliance.

The EU AI Act has been approved and will be phased in gradually. The European Commission has launched the AI Pact to encourage industry players to comply with the forthcoming AI Act ahead of schedule. The Pact offers a framework for collaboration, early adoption of regulations, and responsible AI practices. Participants will play a central role by committing to declarations of engagement and sharing their policies and best practices. The Pact will operate during the transition period until the enforcement of the EU AI Act and may continue to operate afterward. Compliance with the Act is necessary to avoid penalties and reputational damage. Holistic AI can help organizations comply with the EU AI Act safely and confidently.

The EU AI Act introduces a governance structure to ensure coordinated and effective implementation and enforcement of AI regulations at the national and Union levels. The governance framework includes four entities: the AI Office, AI Board, Advisory Forum, and Scientific Panel, each with distinct roles and responsibilities. The AI Office leads the implementation and enforcement of the Act, while the AI Board advises and assists in its consistent application across the EU. The Advisory Forum provides technical expertise and stakeholder input, and the Scientific Panel supports the Act's implementation with scientific insights and guidance. Experts selected for these entities must possess relevant competencies, independence, and scientific or technical expertise in the field of AI. Compliance with the EU AI Act is crucial, and early adoption of its principles can enable smoother compliance.

The EU AI Act introduces standardization instruments such as harmonized standards to facilitate compliance with the Act's requirements and obligations. Providers of high-risk AI systems and general-purpose AI models can enjoy a presumption of compliance if they follow these standardization tools. However, standardization is not mandatory, and providers who do not follow them may face additional workload and penalties for non-compliance. Harmonized standards are expected to cover the requirements for high-risk AI systems and the obligations of providers of GPAI models and GPAI models with systemic risk. Compliance with these standards can help bypass third-party conformity assessments for certain high-risk AI systems, but providers must still ensure compliance for requirements and obligations outside the scope of harmonized standards. The EU AI Act does not become fully operational until mid-2026, but market operators must prepare in advance to comply with the evolving regulatory framework around AI.