Article 43 of the EU AI Act: Conformity Assessment
Article 43 is the gate between building a high-risk system and selling it: the conformity assessment that proves it meets the Act's requirements.
What Article 43 requires
Providers follow one of two procedures: internal control (Annex VI) — a self-assessment used for most Annex III systems; or a notified-body assessment (Annex VII) — required in specific cases, notably certain biometric systems where harmonised standards were not applied. A substantial modification triggers a new assessment.
Who it binds
Providers of high-risk AI systems. After a successful assessment come the declaration of conformity (Art. 47), CE marking (Art. 48) and registration (Art. 49).
Key points
- Two routes: internal control (self-assessment) or notified body.
- Most Annex III systems use internal control.
- A substantial modification requires re-assessment.
FAQ
Do I need a notified body under Article 43?
Usually no — most Annex III systems use internal self-assessment. A notified body is required only in specific cases, such as certain biometric systems without applied harmonised standards.
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