WHAT THE ARTICLE IS ABOUT
The qualification standards for AI conformity assessment bodies
Article 31 is the most detailed article in the notified bodies section. It specifies the full set of requirements — organisational, operational, and technical — that a conformity assessment body must satisfy before it can be designated as a notified body and begin issuing AI Act conformity certificates. It functions as a quality standard for the auditors of high-risk AI.
WHAT IT SAYS
Independence, competence, impartiality and financial soundness
- Notified bodies must be legally established under national law and have legal personality
- They must be third-party bodies — independent of the organisations and AI systems they assess; they must not be the developer, provider, importer, distributor or deployer of any AI system they certify
- They must be financially independent — their income must not depend on the outcome of their assessments
- They must have documented procedures for carrying out their assessment activities and for handling complaints and appeals
- They must have sufficient personnel with the necessary technical knowledge and experience — including expertise in AI, data science, cybersecurity, and relevant sectoral domains
- Their staff must be bound by professional secrecy obligations
- They must carry appropriate liability insurance
- They must participate in coordination activities with other notified bodies
- Where the notified body is part of a larger organisation, it must be structurally separated from other parts of the organisation that could create conflicts of interest
WHO IS AFFECTED
Bodies seeking or holding notified body designation
- Testing and certification organisations seeking to become notified bodies for AI Act purposes
- Existing notified bodies under other EU legislation extending their scope to cover AI systems
- National notifying authorities who assess compliance with these requirements
- Providers of high-risk AI systems who rely on the quality and independence of these bodies
WHAT IT MEANS FOR SMES
Use this article as your checklist when selecting a notified body
- When selecting a notified body for your conformity assessment, Article 31 gives you the criteria to evaluate them — ask for evidence of accreditation, staff qualifications, and conflict of interest policies
- Independence is the most important criterion: a notified body with commercial relationships with AI providers in your sector may have conflicts of interest that compromise the value of their certificate
- The liability insurance requirement matters: if a notified body issues a certificate for a non-compliant system, their insurance is the mechanism for addressing consequential harm
- Smaller or newer notified bodies may technically meet Article 31 requirements but have limited practical experience with AI systems — weigh accreditation against track record
- If a notified body cannot produce their accreditation certificate or demonstrate their separation from commercial AI interests on request, treat this as a red flag
Related Articles
- Article 29 — Application procedure (notified bodies must demonstrate these requirements when applying)
- Article 32 — Presumption of conformity (how harmonised standards help bodies demonstrate compliance with Article 31)
- Article 37 — Challenge to competence (the mechanism for questioning whether a body meets these requirements)
- Article 43 — Conformity assessment (the activities notified bodies perform once designated)
