AI Act Conformity Assessment
A conformity assessment under the EU AI Act is the procedure by which a high-risk AI system is verified to meet the regulation's requirements (Articles 8-15) before being placed on the EU market or put into service.
Full definition
Two paths exist: (1) internal conformity assessment (Annex VI) — the provider self-assesses against the regulation, used for most Annex III high-risk systems; (2) third-party assessment by a notified body (Annex VII) — required for biometric systems and certain product-safety-integrated AI. Successful conformity yields a CE marking and EU declaration of conformity, plus registration in the EU AI database. Substantial modifications trigger reassessment.
Why it matters
Conformity assessment is the gate between developing a high-risk AI system and lawfully selling it in the EU. Cycle time and cost (typically 3-9 months and EUR 100k-1M for first systems) must be in every product timeline and budget.
Example
A medical-device manufacturer integrates AI triage into its product; because the device falls under MDR, it requires third-party notified-body assessment combining MDR and AI Act Annex VII before CE marking.
Related terms
- EU AI ActThe EU AI Act (Regulation (EU) 2024/1689) is the European Union's comprehensive, risk-tiered regulation of AI systems, the world's first horizontal AI law, with obligations phasing in from February 2025 and full general-purpose AI rules applying from August 2025.
- EU AI Act Risk TierEU AI Act risk tiers are the four-level classification — unacceptable, high, limited, and minimal/no risk — that determines which obligations apply to an AI system placed on the EU market under Regulation (EU) 2024/1689.
- Fundamental Rights Impact Assessment (FRIA)A Fundamental Rights Impact Assessment (FRIA) is the structured analysis required by Article 27 of the EU AI Act for certain deployers of high-risk AI systems — bodies governed by public law, private operators of public services, and deployers of credit-scoring or insurance-pricing AI.
- AI GovernanceAI governance is the framework of policies, roles, controls, and processes an organization uses to ensure its AI systems are lawful, safe, fair, accountable, and aligned with business intent — across the full lifecycle from problem framing to retirement.
Source & further reading
Primary source: European Union — Regulation (EU) 2024/1689 on Artificial Intelligence (Articles 43, Annex VI-VII) (2024).
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