Conformity assessment bodies from non-European countries, which have agreements with the EU, can become authorized to carry out conformity assessments required by the AI Act, provided they meet specific requirements set by EU law or demonstrate an equally high standard of compliance and reliability necessary for ensuring safety and trust.
These third-country conformity assessment bodies need to either fulfill all provisions described in Article 31 of the AI Act—which includes independence, impartiality, expertise, and adequate facilities—or guarantee a compliance level equivalent to the strict requirements outlined by the European Union, ensuring consistency and trustworthiness in AI-related evaluations.
No, not all third-country bodies qualify automatically; only those from countries that have a formal agreement with the European Union and also demonstrate conformity with EU standards or an equivalent level of compliance can be authorized as official notified bodies to assess compliance under the AI Act.
Allowing third-country conformity assessment bodies ensures greater global cooperation and consistency in applying AI standards, supports international trade and collaboration, fosters mutual recognition of high standards, and maintains a more practical system for global enrollment of trustworthy AI solutions, provided each ensures EU-level compliance.
