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EC AI Act & Regulation · EU-wide · Guidance

Standardisation of the AI Act

AI-generated summary

The European Commission describes how harmonised standards will support implementation of the AI Act, which regulates high-risk AI systems affecting safety, health, and fundamental rights. The European Committee for Standardisation (CEN) and European Committee for Electrotechnical Standardisation (CENELEC) are developing standards covering risk management, dataset governance, transparency, human oversight, and other areas. On 30 October 2025, prEN 18286 on quality management systems became the first harmonised AI standard to enter public enquiry. Applying harmonised standards remains voluntary but provides legal certainty and presumed compliance with AI Act requirements.

From EC AI Act & Regulation

Harmonised standards will offer legal certainty under the AI Act, support innovation, and position the EU to set global benchmarks for trustworthy AI.

Ensuring an effective and clear implementation of the AI Act is a priority for the Commission. The AI Act regulates regulates ‘high-risk’ AI systems that impact safety, health, and fundamental rights, for example, in critical infrastructure and law enforcement, among other areas (see article 6 and annex III of the AI Act). These requirements need to be fulfilled before placement on the market, ensuring high-risk AI systems are monitored throughout their lifecycle.

Standards translate legal requirements into common technical language, simplifying compliance for companies and other stakeholders.

European harmonised standards serve several crucial functions:

- Legal certainty and reduced compliance costs: European harmonised standards provide a clear pathway to compliance for businesses of all sizes.

- Market benchmarking: European harmonised standards often become de facto global benchmarks. For example, standards currently under development focused on setting methodologies for risk management and quality management are strong candidates to become market benchmarks in the future.

- Innovation and competitiveness: European harmonised standards foster trust and market acceptance, enabling developers who adopt them to compete on a global scale while ensuring their solutions meet the highest safety standards.

How are standards developed and what are the current standards?

The European Committee for Standardisation (CEN) and European Committee for Electrotechnical Standardisation (CENELEC) are European Standardisation Organisations. Working groups in these 2 organisations are actively developing harmonised standards for high-risk AI systems. They work together in a Joint Technical Committee called JTC 21.

- risk management

- governance and quality of datasets

- record keeping

- transparency

- human oversight

- accuracy

- robustness

- cybersecurity

- quality management

- conformity assessment

Once harmonised standards are published by CEN and CENELEC, the Commission assesses whether they meet the intended objectives and legal requirements of the AI Act. After this final step, the standards are referenced in the Official Journal of the EU.

The application of standards remains voluntary. Providers can choose any other framework to demonstrate their compliance with the AI Act. However, harmonised standards referenced in the Official Journal of the EU provide legal certainty. Companies that apply harmonised standards are presumed to be compliant with the legal requirements.

Excerpt from the official page. The original is authoritative. Continue reading at EC AI Act & Regulation ↗