Conformity assessment
Also known as: EU AI Act conformity assessment, Article 43 assessment
Under EU AI Act Article 43, the procedure providers of high-risk AI systems must complete to demonstrate compliance with Articles 9-15 before placing the system on the EU market. For most Annex III systems the assessment is internal (Annex VI procedure); for biometric identification and certain other categories it requires a notified body (Annex VII procedure). The assessment produces the EU declaration of conformity and the CE marking.
Conformity assessment is the load-bearing artefact most 2025-era enterprise pilot budgets do not account for. Internal assessment is doable in 6-12 weeks once the technical documentation, risk-management system, quality-management system, and Article 12 logging are in place. Externally-assessed systems (notified-body Annex VII) take materially longer. The August 2026 enforcement deadline means most Annex III deployments need the assessment package complete by Q3 2026 — many programmes are still building the substrate the assessment will evaluate.
Related frameworks
Articles that analyse this term
Primary sources
- European Union. EU AI Act — Article 43
- European Commission. Notified bodies under the AI Act