EU AI Act Article 43 — Conformity Assessment + CE Marking

Conformity assessment is the procedure providers of high-risk AI systems use to demonstrate compliance with Articles 9-15 + 17-22 (the high-risk requirements) before placing the system on the EU market. Two procedures: (a) internal control / self-assessment per Annex VI for most Annex III high-risk systems, OR (b) third-party Notified Body audit per Annex VII for Annex I high-risk + biometric ID systems.

Annex I high-risk systems (those tied to existing EU product safety legislation — medical devices, machinery, vehicles, toys, etc.) generally need Notified Body assessment. Annex III high-risk (employment, education, law enforcement, migration, etc.) generally use internal/self-assessment, with limited exceptions for biometric identification systems.

After successful conformity assessment, the provider draws up an EU declaration of conformity (Article 47), affixes the CE marking (Article 48), and registers the system in the EU public database (Article 49 + 71). The CE marking is the visible signal that the system has gone through conformity assessment.

Annex III high-risk obligations were delayed by the Digital Omnibus (March 2026) to 2 December 2027. Annex I high-risk delayed to 2 August 2028. So most providers have until late 2027 to ship conformity-assessed Annex III systems.

meok-cra-annex-iv-classifier-mcp generates the Annex IV technical documentation that conformity assessment requires. meok-governance-engine-mcp produces the EU declaration of conformity template per Annex V. /audit-prep-bundle £4,950 wraps Article 43 + Annex IV + Articles 9-15 in a 14-day signed evidence pack ready for self-assessment or Notified Body submission.