Chapter IIIHigh-Risk
Article 34
Operational Obligations of Notified Bodies
Plain-Language Summary
Notified bodies must carry out conformity assessments impartially, set fees that do not depend on the outcome of assessment, protect confidential information, and participate in standardisation and coordination activities.
Keywords
notified bodiesoperational obligationsfeesconfidentialitystandardisationcoordination
Legal Text
Article 34 — Operational Obligations of Notified Bodies Notified bodies shall: (a) carry out conformity assessments in accordance with the conformity assessment procedures provided for in Articles 43 to 46; (b) keep the technical documentation and the EU declaration of conformity as referred to in Articles 11 and 47 at the disposal of national authorities for at least 10 years after the issuance of a certificate; (c) where relevant, provide the relevant information to national market surveillance authorities; (d) participate in relevant standardisation activities and in the coordination group of notified bodies for high-risk AI systems; (e) set fees that are reasonable, proportionate, and that do not depend on the outcome of the conformity assessment; (f) protect the confidentiality of the information obtained in the course of their tasks.