Article 39
Conformity assessment bodies of third countries
Common Questions
Frequently Asked Questions
What are conformity assessment bodies from third countries allowed to do under the AI Act?
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.
What conditions must third-country bodies meet to be considered as notified bodies?
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.
Do all third-country conformity assessment bodies qualify automatically under EU rules?
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.
Why does the EU allow third-country conformity assessment bodies instead of using exclusively European bodies?
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.