Conformity Assessment

Definition

Conformity assessment is the formal procedure through which an AI provider demonstrates that their high-risk AI system complies with the EU AI Act requirements before placing it on the EU market.

Article 43 of the EU AI Act governs this procedure. Upon successful completion, the provider draws up an EU declaration of conformity and affixes the CE marking to the system.

Two procedures

Internal conformity assessment (most providers)

For the majority of high-risk AI systems (those not covered by Union harmonisation legislation for safety components), providers may conduct internal conformity assessment under Annex VI. This means:

• The provider self-assesses against all Chapter III requirements
• No third party (notified body) is required
• The provider must still have a complete Annex IV technical file and a quality management system

Third-party assessment (notified body)

Certain categories — notably AI systems used as safety components of products covered by EU machinery or medical devices legislation, and some biometric identification systems — require assessment by a notified body: an independent conformity assessment body accredited by a national authority.

What conformity assessment evaluates

The procedure checks that the provider has:

1. Implemented a quality management system (Article 17)
2. Drawn up complete technical documentation per Annex IV
3. Enabled automatic logging where required (Article 12)
4. Implemented human oversight measures (Article 14)
5. Achieved the accuracy, robustness, and cybersecurity requirements of Article 15
6. Established post-market monitoring (Article 72)

The technical file as the core input

The Annex IV technical file is the primary document that demonstrating compliance. Without a complete, evidence-linked technical file, a provider cannot:

• Draw up the EU declaration of conformity
• Affix CE marking
• Register the system in the EU AI Act database
• Lawfully place the system on the EU market

→ Build your technical file with modeldocs or read the full Annex IV requirements guide.