Article 39: Conformity Assessment Bodies of Third Countries
Article 39 addresses how conformity assessment bodies established in third countries (outside the EU) may be accepted under the AI Act. Acceptance requires an international agreement — specifically a mutual recognition agreement or equivalent arrangement — between the Union and the third country. This ensures that third-country bodies meet equivalent levels of competence and independence before their assessments are recognised within the EU single market.
Who does this apply to?
- -Third-country conformity assessment bodies seeking recognition to perform AI Act assessments
- -The European Commission and Union institutions negotiating mutual recognition agreements with third countries
- -Providers of high-risk AI systems who may wish to use conformity assessment bodies established outside the EU
Scenarios
A US-based conformity assessment body, already accredited for ISO/IEC 17065 product certification, wants to perform AI Act conformity assessments for EU-bound AI systems developed by American companies.
The EU and a third country with a mature AI ecosystem conclude a mutual recognition agreement covering conformity assessment for AI systems. A conformity assessment body in that country meets the equivalent of Article 30 requirements.
The mutual recognition requirement
Article 39 establishes a clear prerequisite: conformity assessment bodies established in third countries may only be accepted for AI Act purposes where the Union and the third country have concluded a mutual recognition agreement or an equivalent arrangement.
This means: - There is no unilateral route for a third-country body to gain AI Act recognition - The agreement must ensure equivalent levels of competence and independence — essentially, the third-country body must meet standards comparable to Article 30 - Until such an agreement exists, providers selling into the EU must use notified bodies designated by EU Member States
Current state of mutual recognition
As of the date of this page, the EU has not concluded mutual recognition agreements specifically covering AI Act conformity assessment with any third country. Existing mutual recognition agreements (e.g., the EU-US MRA on conformity assessment) cover specific product sectors and would need to be extended or supplemented to cover AI.
Providers established outside the EU should plan on the basis that they will need to engage an EU-notified body for conformity assessment of high-risk AI systems placed on the Union market. This may change as the Commission negotiates new agreements.
How Article 39 fits the wider framework
- Article 28 — Obligations of importers and distributors, who play a key role when products from third countries enter the EU market.
- Article 30 — The competence and independence requirements that third-country bodies must equivalently meet.
- Article 43 — The conformity-assessment procedures that recognised third-country bodies would carry out.
- Article 113 — Application dates.
Compliance checklist
- If you are a provider outside the EU, identify whether a mutual recognition agreement exists between your country and the EU covering AI Act conformity assessment.
- In the absence of such an agreement, plan to engage an EU-notified body listed in the NANDO database.
- If you are an importer, verify that the conformity assessment was performed by a properly notified body — a third-country body without mutual recognition backing is insufficient.
- Monitor Commission announcements for new mutual recognition negotiations or agreements that may affect your market access strategy.
- Retain evidence of the conformity assessment body's notification status (or mutual recognition basis) in your compliance file.
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Frequently asked questions
Can a provider outside the EU use a local conformity assessment body for AI Act purposes?
Only if the EU has concluded a mutual recognition agreement or equivalent arrangement with the provider's country that covers AI Act conformity assessment. Otherwise, the provider must use an EU-notified body.
Do existing EU mutual recognition agreements cover the AI Act?
Existing agreements (e.g., with the US, Canada, or Switzerland) cover specific product sectors and do not automatically extend to AI Act conformity assessment. They would need to be amended or supplemented.
What if a third-country body has ISO/IEC 17065 accreditation?
Accreditation alone is not sufficient. Article 39 requires a formal mutual recognition agreement at the intergovernmental level. Accreditation may support the body's qualification but does not substitute for the agreement.