Certification and Conformity Assessment

High-risk AI systems are subject to formal conformity assessment procedures before being placed on the market or put into service. This assessment can take two main forms:

• Supplier self-assessment, in cases where the AI system is not incorporated into a product subject to sectoral regulation (e.g., standalone software);
• Third-party assessment by notified bodies, when the system is integrated into products covered by existing European legislation, such as medical devices, toys, motor vehicles, among others.

These notified bodies will be independent entities, nationally accredited to conduct technical audits, inspect documentation, test systems, and verify that development processes comply with the AI Act requirements.

A compliant system obtains a CE conformity declaration, confirming that it meets the regulation’s obligations. This certification will be mandatory for the legal marketing of high-risk AI systems within the European Union.