Presumption of conformity
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 Simple Version
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.
Detailed Explanation
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.
Key Characteristics
- Rebuttable by market-surveillance authorities with contrary evidence
- Applies only where the harmonised standard fully covers the relevant legal requirement
- Lowers documentation burden for providers following referenced standards
- Parallel mechanism exists via Commission common specifications when no standard is available
Why It Matters
Providers evaluating compliance strategies can use presumption of conformity to reduce audit costs and streamline market entry, particularly where harmonised standards are mature.
Real-World Analogy
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.
Common Misconceptions
- Presumption of conformity is absolute, it is rebuttable; authorities retain the right to challenge compliance with evidence.
- Any ISO standard triggers the presumption, only harmonised standards referenced in the EU Official Journal or Commission common specifications create the presumption.