Summary of Article 29
- Application for Notification: Conformity assessment bodies must submit an application to the notifying authority, including details of their activities, modules, AI systems, and accreditation certificates or relevant documents from other Union legislation.
- Alternative Evidence for Compliance: Conformity assessment bodies without accreditation certificates must provide sufficient documentary evidence to demonstrate compliance with the requirements of Article 31.
- Ongoing Documentation and Updates: Notified bodies must use existing documents from other Union legislation, if applicable, and update their documentation to ensure continuous compliance with Article 31 requirements.
Application for Notification
1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established.
2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the types of AI systems for which the conformity assessment body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment 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.
Alternative Evidence for Compliance
3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 31.
Ongoing Documentation and Updates
4. For notified bodies which are designated under any other Union harmonisation legislation, all documents and certificates linked to those designations may be used to support their designation procedure under this Regulation, as appropriate. The notified body shall update the documentation referred 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.
