Harmonized standard
An official European technical standard that, if followed, is accepted as proof that an AI product meets the relevant EU law.
The Simple Version
An official European technical standard that, if followed, is accepted as proof that an AI product meets the relevant EU law.
Detailed Explanation
Harmonised standards are a cornerstone of the EU's New Approach legislation. When the Commission issues a standardisation request to CEN/CENELEC or ETSI, the resulting standard is published in the Official Journal with references to the regulation it supports. Providers applying harmonised standards benefit from the presumption of conformity, regulators accept compliance with the standard as satisfaction of the corresponding legal requirements, without needing to prove compliance independently. For the EU AI Act, harmonised standards covering risk management, data governance, and transparency are expected to reference ISO/IEC 42001 and related standards.
Key Characteristics
- Developed by CEN, CENELEC, or ETSI under Commission standardisation mandate
- Referenced in the Official Journal to trigger the presumption of conformity
- Voluntary to use, but creates a 'safe harbour' from conformity challenges
- Common specifications issued by Commission can substitute if no harmonised standard exists
Why It Matters
Compliance teams should monitor Official Journal publications for harmonised AI standards; aligning product development with draft standards early reduces future rework.
Real-World Analogy
Following a government-endorsed building code gives builders a presumption that their structure meets safety regulations, using a harmonised standard plays the same role for AI product compliance.
Common Misconceptions
- Using a harmonised standard is mandatory for market access, it is voluntary; providers can demonstrate compliance by other means, but must then provide fuller evidence.
- ISO/IEC standards automatically qualify as harmonised. ISO standards become harmonised only after being adopted into CEN/CENELEC with an EU Commission reference in the Official Journal.