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Chapter IIIHigh-Risk

Article 29

Requirements Relating to Notified Bodies

Plain-Language Summary

Specifies the requirements that notified bodies must meet: independence, technical competence, financial standing, staff qualifications, confidentiality obligations, and liability insurance. Bodies must not engage in activities that could compromise their independence.

Keywords

notified bodiesrequirementsindependenceimpartialitytechnical competenceconfidentialityaccreditation

Legal Text

Article 29 — Requirements Relating to Notified Bodies

1. A notified body shall satisfy the following requirements:
(a) it shall be established under national law and have legal personality;
(b) it shall be independent of the organisation or the AI system it assesses;
(c) it shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities;
(d) it shall have the financial stability required to perform its activities and meet its contractual obligations;
(e) its personnel shall be bound by professional secrecy with regard to all information obtained during the performance of their tasks.

2. Notified bodies shall have available the necessary internal competences to effectively perform the technical and administrative tasks in relation to the conformity assessment. This includes competence in the field of information technologies, cybersecurity, and the relevant AI techniques.

3. Notified bodies shall maintain documented policies and procedures for the confidential handling of information.