A legal shortcut: if you follow the approved technical standard, regulators assume your AI product meets the law without you needing to prove each requirement individually.
A legal shortcut: if you follow the approved technical standard, regulators assume your AI product meets the law without you needing to prove each requirement individually.
The presumption of conformity is a rebuttable presumption — authorities can challenge it if they have evidence of non-compliance, but the burden of proof shifts to the challenger. This mechanism incentivises adoption of harmonised standards and reduces compliance friction. It applies in full only when the standard covers the relevant requirement completely; partial coverage of a harmonised standard creates a partial presumption for the covered areas only.
Providers evaluating compliance strategies can use presumption of conformity to reduce audit costs and streamline market entry, particularly where harmonised standards are mature.
A food manufacturer using an approved Hazard Analysis and Critical Control Points (HACCP) plan is presumed to comply with food safety law — inspectors may still audit, but they must first produce evidence of non-compliance.
A legal shortcut: if you follow the approved technical standard, regulators assume your AI product meets the law without you needing to prove each requirement individually.
The presumption of conformity is a rebuttable presumption — authorities can challenge it if they have evidence of non-compliance, but the burden of proof shifts to the challenger. This mechanism incentivises adoption of harmonised standards and reduces compliance friction. It applies in full only when the standard covers the relevant requirement completely; partial coverage of a harmonised standard creates a partial presumption for the covered areas only.
Providers evaluating compliance strategies can use presumption of conformity to reduce audit costs and streamline market entry, particularly where harmonised standards are mature.