European Harmonised Standards

The European Artificial Intelligence Regulation (AI Act), stipulates that compliance with AI system requirements, particularly for systems categorised as high-risk, must be demonstrated by reference to harmonised technical standards developed by recognised European standardisation bodies. These bodies include CEN (the European Committee for Standardisation) and CENELEC (the European Committee for Electrotechnical Standardisation).

These standards serve as technical benchmarks to help economic operators — including providers, deployers, and users — align their processes and products with the Regulation's requirements.

The standards are expected to cover the following areas:

• Data quality and representativeness in model training;
• Risk assessment and mitigation methods;
• System robustness and cybersecurity;
• Algorithmic transparency and explainability;
• Human oversight and controllability;
• Record-keeping and technical documentation requirements.

Although adoption of the standards is voluntary, compliance creates a presumption of conformity with the Regulation's legal requirements. This allows companies to reduce administrative burdens and streamline conformity assessment and market placement procedures for their AI systems.