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A legal mechanism under EU AI Act and other regimes whereby compliance with a harmonized standard (e.g., a published EN standard) provides a rebuttable assumption that the underlying regulation is satisfied.
Once a harmonized standard is published in the EU Official Journal, organizations that demonstrate conformance with it benefit from the presumption that they satisfy the corresponding regulatory requirements. This significantly simplifies compliance evidence: instead of arguing direct compliance with often-abstract regulatory text, organizations point to certification against the harmonized standard. Where a harmonized standard exists for an AI governance regulation, certification against it provides the simplest defensible compliance path. Where one does not, organizations must demonstrate compliance through other documented means.
Real world example:
An enterprise certified against a harmonized standard for AI risk management benefits from a presumption of conformity with the corresponding regulatory obligations - significantly reducing audit complexity compared with arguing direct compliance against the underlying regulatory text.
