EU AI Act Conformity Assessment and Notified Bodies

Article 43 uses different routes for different high-risk AI systems. For high-risk systems listed in point 1 of Annex III, the provider may use Annex VI internal control only when it demonstrates compliance by applying harmonised standards under Article 40 or, where applicable, common specifications under Article 41.

For that same Annex III point 1 category, Annex VII notified-body assessment is required when harmonised standards and common specifications are not available, when the provider has not applied the relevant harmonised standard or has applied only part of it, when available common specifications have not been applied, or when a harmonised standard has been published with a restriction for the restricted part.

For high-risk AI systems in points 2 to 8 of Annex III, Article 43 says providers follow Annex VI internal control, with no notified-body involvement. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider follows the conformity assessment required by that product law, and the AI Act Section 2 requirements become part of that assessment.

Annex VI internal control is still a formal conformity assessment. The provider verifies that its quality management system complies with Article 17, examines the technical documentation to assess compliance with Chapter III Section 2 requirements, and verifies that design, development, and post-market monitoring are consistent with the technical documentation.

The evidence should therefore be more than a checklist. Article 11 requires technical documentation to be drawn up before placing the high-risk AI system on the market or putting it into service, kept up to date, and written so competent authorities and notified bodies can assess compliance. Annex IV lists expected content, including intended purpose, system versions, development methods, data requirements, human oversight, validation and testing, cybersecurity, risk management, standards used, the EU declaration of conformity, and post-market monitoring.

Annex VII adds notified-body review of both the provider's quality management system and the technical documentation for the AI system. The provider's application includes provider identity, the AI systems covered by the same quality management system, technical documentation for each system, quality-management documentation covering Article 17, procedures to keep the system adequate and effective, and a declaration that the same application was not lodged with another notified body.

The notified body examines whether the quality management system satisfies Article 17 and examines the technical documentation. Where needed, it may require further evidence or tests, carry out tests itself, and, after other reasonable means are insufficient, request access to training and trained models subject to applicable protection for intellectual property and trade secrets. If the system conforms, the notified body issues a Union technical documentation assessment certificate; if not, it refuses and gives reasons.

After approval, Annex VII creates an ongoing change and surveillance track. Intended changes to the approved quality management system, the covered system list, or an AI system change that could affect compliance or intended purpose must be brought to the notified body. The notified body carries out surveillance of the approved quality management system, including periodic audits.

The conformity assessment route should close into release evidence. Article 47 requires the provider to draw up a written, machine-readable, physical, or electronically signed EU declaration of conformity for each high-risk AI system, keep it available to national competent authorities for 10 years, identify the system, state conformity with the Section 2 requirements, include Annex V information, translate it for relevant national competent authorities, and keep it up to date.

Article 48 requires CE marking for high-risk AI systems. For digital high-risk AI systems, a digital CE marking can be used only when it is easily accessible through the system interface or through an accessible machine-readable code or other electronic means. Where a notified body was responsible for the Article 43 conformity assessment, its identification number follows the CE marking and is also indicated in promotional material that mentions CE conformity.

Article 49 registration is separate from CE marking and must be checked before release. Providers or authorised representatives register themselves and Annex III high-risk AI systems in the EU database before placing them on the market or putting them into service, except for point 2 of Annex III. Providers also register systems they concluded are not high risk under Article 6(3). Public authorities, Union institutions, bodies, offices, agencies, and persons acting on their behalf have deployer registration duties for covered Annex III systems before use.