Your mandated EU point of contact under Article 22 of the AI Act

Conformity assessment, CE marking and EU database registration

Before a high-risk AI system is placed on the market, the provider completes a conformity assessment, draws up an EU declaration of conformity, affixes the CE marking and, for Annex III systems, registers the system in the EU database.

Free eligibility check All guides

Article 43 AI Act Annex VI internal control Annex VII notified body Article 49 EU database

Which procedure applies

System	Procedure
Most Annex III high-risk systems (points 2 to 8)	Internal control, Annex VI - no notified body
Biometrics (Annex III point 1)	Internal control where harmonised standards or common specifications are applied in full; otherwise a notified body under Annex VII
Annex I, Section A product-related systems (for example medical devices, IVDs, toys, radio equipment)	The conformity assessment of the relevant product legislation, which also covers the AI Act requirements

After the assessment

Declaration

Draw up a written EU declaration of conformity (Article 47, Annex V) and keep it for 10 years.

CE marking

Affix the CE marking visibly, legibly and indelibly - digitally for systems provided digitally (Article 48).

Registration

Substantial modification

A substantial modification requires a new conformity assessment.

The authorised representative's part

For a provider outside the EU, the authorised representative verifies that the declaration of conformity and technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out, and, where the provider registers the system itself, verifies that the registration information is correct.

Frequently asked questions

Do most high-risk AI systems need a notified body?

No. Most Annex III systems follow internal control under Annex VI. Biometric systems need a notified body where harmonised standards or common specifications are not applied in full.

Is CE marking required for AI systems?

Yes, for high-risk AI systems. Systems provided only digitally use a digital CE marking.

Which systems must be registered in the EU database?

High-risk AI systems listed in Annex III, before they are placed on the market or put into service; critical infrastructure systems are registered at national level.