Sourceoftruth
#EU-ACT-ART-29|HIGH RISK
stableregulation

Article 29: Application for Notification by a Conformity Assessment Body

Official Statutory Text

Article 29 Application of a conformityassessment body for notification 1. Conformityassessment bodies shall submit an application for notification to the notifying authority of the Member State in which theyare established. 2. The application for notification shall be accompanied bya description of the conformityassessment activities, the conformityassessment module or modules and the types of AI systems for which the conformityassessment body claims to be compet ent, as well as byan accreditation certificate, where one exists, issued bya national accreditation bodyattesting that the conformityassessment 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 conformityassessment body concerned cannot provide an accreditation certif icate, it shall provide the notifying authority with all the documentary evidence necessary for the ver ifi cation, recognition and regular monitoring of its compliance with the requirements laid down in Article 31. 4. For notified bodies which are designatedunder any other Union harmonisation legislation, all documents and certif icat es linked to those designations maybe used to support their designation procedure under this Regulation, as appropr iate. The notified body shall update the documentation refer red to in paragraphs 2 and 3 of this Article whenever relevant changes occur , in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements laid down in Article 31.

Legal Authority

European Parliament & Council (Regulation 2024/1689)

View Official EUR-Lex Publication
Mandatory Statutory Checklist & Fix
  • For conformity assessment bodies: Submit an application for notification to the notifying authority of the Member State in which you are established.
  • Your application must be accompanied by:
    • A description of the conformity assessment activities, modules, and types of AI systems for which you claim competence.
    • An accreditation certificate (if available) issued by a national accreditation body, attesting to your fulfillmentof Article 31 requirements.
    • Any valid documents related to existing designations under other Union harmonisation legislation.
  • If an accreditation certificate is not available, provide the notifying authority with all necessary documentary evidence for verification, recognition, and regular monitoring of your compliance with Article 31 requirements.
  • For notified bodies designated under other Union harmonisation legislation, update your documentation (from paragraphs 2 and 3) whenever relevant changes occur, to enable continuous monitoring of Article 31 compliance.
Statutory Classification
HIGH RISK

Applies directly across all 27 EU Member States with phased entry into force from 2025 to 2026.