Chapter IIIHigh-Risk
Article 33
Notified Bodies
Plain-Language Summary
Specifies the operations and conduct of notified bodies: they must carry out conformity assessments in a proportionate manner, set up an appeals procedure, and keep records of conformity assessment activities for at least 10 years.
Keywords
notified bodiesoperationsconductconformity assessmentcertificatesobjectivity
Legal Text
Article 33 — Notified Bodies 1. Notified bodies shall be established, organised, and operated in a way that preserves the objectivity and impartiality of their activities. 2. Notified bodies shall document their internal organisation and functioning, the distribution of functions, the responsibilities of their personnel and, where applicable, the tasks and responsibilities of their subsidiaries and subcontractors. 3. Notified bodies shall carry out conformity assessments with due regard to the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the AI system in question and the mass or serial nature of the production process. 4. Notified bodies shall comply with the requirements of the relevant harmonised standards and common specifications that are applicable to their activities. 5. Where a notified body finds that a provider has not met the requirements set out in Section 2 of this Chapter, it shall request that provider to take appropriate corrective actions and shall not issue a certificate.