Art.39

Article 39 — Conformity Assessment Bodies of Third Countries

Governance SME Relevant ~2 min read · 453 words

Article 39 opens the EU’s conformity assessment system to bodies established outside the EU — but only where international agreements permit it. It ensures that third-country assessment bodies operate on equivalent terms to EU notified bodies, and that the mutual recognition framework supports global trade in AI systems without compromising standards.

✓ Low compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

Extending the notified body framework to non-EU assessment organisations

Article 39 deals with conformity assessment bodies established in third countries — non-EU nations. It establishes the conditions under which such bodies can be accepted as equivalent to EU notified bodies, enabling AI systems assessed by third-country bodies to rely on those assessments when entering the EU market. This is primarily relevant in the context of bilateral trade agreements and mutual recognition arrangements.

WHAT IT SAYS

International agreements, equivalent standards, and reciprocal access

Third-country conformity assessment bodies may be accepted as equivalent to EU notified bodies only where an international agreement between the EU and the relevant third country provides for this
Such agreements must ensure that third-country bodies meet requirements equivalent to those in Article 31
The Commission may negotiate and conclude such agreements — they are not automatic or bilateral by default
Third-country bodies accepted under such agreements must be listed and identifiable in a manner equivalent to the NANDO register
Where no international agreement exists, a third-country body cannot issue certificates that carry EU legal standing under the AI Act
Providers seeking to use a third-country assessment body should verify whether an applicable agreement is in force before engaging that body

WHO IS AFFECTED

Non-EU providers and third-country assessment bodies

Non-EU AI system providers who may wish to use assessment bodies in their home country
Third-country conformity assessment bodies seeking to serve EU-bound AI providers
The European Commission negotiating international agreements
EU importers of AI systems assessed by third-country bodies
Member states and notifying authorities implementing any resulting mutual recognition arrangements

WHAT IT MEANS FOR SMES

Currently limited practical impact — but watch trade agreement developments

As of the AI Act’s entry into force, no mutual recognition agreements for AI conformity assessment bodies are yet in place — this article is forward-looking infrastructure
For EU-based SMEs: no practical impact currently — your notified body must be EU-designated
For non-EU SMEs exporting to the EU: you currently cannot use a home-country assessment body unless an applicable agreement exists — verify the current state of any relevant EU trade agreements before assuming third-country assessment will be accepted
Watch for EU-UK, EU-US, and EU-Japan trade agreement developments — these are the most likely first candidates for AI mutual recognition arrangements
The UK’s position is particularly relevant for many businesses — post-Brexit, UK conformity assessment bodies are third-country bodies under this article and cannot currently issue EU-valid AI Act certificates

Article 31 — Requirements for notified bodies (the equivalent standard third-country bodies must meet)
Article 35 — NANDO register (where third-country bodies accepted under agreements would be listed)
Article 22 — Authorised representatives (non-EU providers must still appoint one regardless of where assessment occurs)
Article 43 — Conformity assessment (the procedure third-country bodies would be conducting)

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