Presumption of conformity with requirements relating to notified bodies

A notified body is an organization approved to check that certain artificial intelligence systems comply with essential safety, transparency, and accountability standards set by the AI Act, helping to ensure products are safe and trustworthy before they can be marketed or used within the European Union.

'Presumption of conformity' means that if an assessment organization shows it meets approved EU standards published in the Official Journal, it is automatically assumed to meet specific official requirements outlined in the regulation, making certification quicker and easier without requiring additional proof or documentation.

Harmonized standards that give presumption of conformity are officially listed in the Official Journal of the European Union; checking this published list helps conformity assessment bodies identify the exact standards they must follow to satisfy certain legal requirements in line with the AI Act.

While conformity assessment bodies aren't strictly required to use harmonized standards, if they choose to do so and fully meet those published standards, they'll automatically benefit from presumption of conformity, thereby simplifying the official assessment process under provisions outlined by the AI Act.