Chapter IIIHigh-Risk
Article 44
Certificates Issued by Notified Bodies
Plain-Language Summary
Notified bodies must issue EU technical documentation assessment certificates and quality management system assessment certificates where conformity has been established. Certificates must specify validity period, conditions, and be kept for at least 10 years.
Keywords
certificatesnotified bodiestechnical documentationquality managementvalidityrenewal
Legal Text
Article 44 — Certificates Issued by Notified Bodies 1. Where a notified body finds that a provider has satisfied the requirements set out in Section 2 of this Chapter, it shall issue a EU technical documentation assessment certificate and a EU quality management system certificate, as applicable. 2. The certificates shall contain the provider's name and address, the conclusions of the assessment, the conditions for the validity of the certificate and the necessary data for identification of the assessed AI system. 3. Certificates shall be valid for a maximum period of 4 years and may be renewed for further periods of up to 4 years. 4. The Commission may, by means of implementing acts, establish the format and content of the certificates and of the documentation required for the application.