Article 29; Article 28(8); Annex XIV(4)
CurrentFrom 2 Aug 2025Submit and Maintain the Application for Notification as an AI Conformity Assessment Body
Applies to Conformity Assessment Body / Notified Body.
- Actors
- Conformity Assessment BodyNotified Body
- Themes
- Risk & AssuranceMonitoring, Reporting & Improvement
Tracker Guidance
Submit the notification application to the notifying authority of the Member State where the conformity assessment body is established. Include the required description of conformity-assessment activities, modules and AI-system competence, together with an accreditation certificate where available or equivalent documentary evidence. Use the Annex XIV codes, categories and corresponding AI-system types to specify the requested scope of designation. Add valid documents from existing designations under other Union harmonisation legislation. Where the Article 28(8) unified-assessment route applies for Annex I Section A legislation, submit the single application to the notifying authority designated under that sectoral legislation. Update the supporting documentation whenever relevant changes occur.
Official text
1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established. 2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the types of AI systems for which the conformity assessment body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 31. Any valid document related to existing designations of the applicant notified body under any other Union harmonisation legislation shall be added. 3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 31. [Excerpt - see official source for complete provision]
Excerpt stored at a complete legal-unit boundary. See the official source for the full provision.
8. Notifying authorities designated pursuant to this Regulation that are responsible for AI systems covered by the Union harmonisation legislation listed in Section A of Annex I shall ensure that the conformity assessment body that applies for designation both pursuant to this Regulation and the Union harmonisation legislation listed in Section A of Annex I is provided with the possibility to submit a single application and undergoes a unified assessment procedure to be designated pursuant to this Regulation and Union harmonisation legislation listed in Section A of Annex I, where the relevant Union harmonisation legislation provides for such single application and unified assessment procedure. To that end, notifying authorities designated pursuant to this Regulation and those designated pursuant to the Union harmonisation legislation listed in Section A of Annex I shall cooperate in their assessments. The single application and the unified assessment procedure referred to in this paragraph shall also be made available to notified bodies already designated pursuant to the Union harmonisation legislation listed in Section A of Annex I, when those notified bodies apply for designation pursuant to this Regulation, provided that the relevant Union harmonisation legislation provides for such a procedure. A conformity assessment body that is designated pursuant to more than one piece of Union harmonisation legislation listed in Section A of Annex I shall have to apply only once to be designated pursuant to this Regulation. A designation pursuant to this Regulation shall be applicable for all Union harmonisation legislation listed in Section A of Annex I for which the conformity assessment body is designated. [Excerpt - see official source for complete provision]
Excerpt stored at a complete legal-unit boundary. See the official source for the full provision.
4. Application for designation Conformity assessment bodies shall use the lists of codes, categories and corresponding types of AI systems set out in this Annex when specifying the types of AI systems in the application for designation referred to in Article 29.