WHAT THE ARTICLE IS ABOUT
How conformity assessment bodies become notified bodies
Article 29 establishes the application and notification procedure for conformity assessment bodies seeking official designation as notified bodies under the AI Act. Notified bodies are the organisations authorised to conduct third-party conformity assessments of high-risk AI systems. This article defines the front door of that designation process.
WHAT IT SAYS
Application, accreditation, and Commission notification
- Conformity assessment bodies must submit an application for notification to the notifying authority of the member state in which they are established
- The application must include: a description of the conformity assessment activities they intend to carry out, the assessment modules they will use, the types of AI systems they claim competence to assess, and an accreditation certificate from a national accreditation body where one exists
- Where no accreditation certificate is available, the applicant must provide documentary evidence sufficient for the notifying authority to verify its competence
- The notifying authority assesses the application and, if satisfied, formally notifies the Commission and other member states of the designation
- The notification is made through the Commission’s NANDO electronic notification tool
- Existing designations under other EU harmonisation legislation are taken into account — bodies already notified under the Medical Devices Regulation or Machinery Directive, for example, may build on those designations
WHO IS AFFECTED
Testing and certification bodies seeking AI audit designation
- Testing laboratories, certification bodies, and inspection organisations that wish to conduct third-party AI conformity assessments commercially
- Bodies already notified under other EU product safety legislation who wish to extend their designation to cover AI systems
- National accreditation bodies that assess the competence of applicant conformity assessment bodies
- National notifying authorities that process and evaluate the applications
WHAT IT MEANS FOR SMES
Context for choosing a notified body — not a direct obligation
- This article does not impose any obligation on SMEs — it governs the process by which assessment bodies become authorised, not the process by which providers use them
- Understanding this article helps when selecting a notified body: a body that has gone through this rigorous designation process and appears in the NANDO register has been verified as competent by national authorities
- Beware of unregistered bodies claiming to offer AI Act conformity assessments — only officially designated notified bodies appearing in NANDO have legal standing to issue certificates under the Act
- The accreditation requirement is meaningful: bodies accredited under ISO 17021 or ISO 17065 for relevant scopes have demonstrated baseline competence that the notifying authority has independently verified
Related Articles
- Article 28 — Notifying authorities (the bodies that receive and process these applications)
- Article 31 — Requirements for notified bodies (the standards applicants must demonstrate)
- Article 30 — Notification procedure (what happens after the application is approved)
- Article 35 — Identification numbers and lists (where approved notified bodies are publicly listed)
