Art. 29 Application of a conformity assessment body for notification | AI act regulation | AI act

This article sets out the application procedure that conformity assessment bodies must follow in order to be officially notified under the regulation.

It feeds directly into the broader framework established by Articles 28 and 31, where Article 28 establishes the role of notifying authorities and Article 31 defines the requirements a conformity assessment body must meet.

Article 29 sits in between, detailing what a body must submit to the relevant national notifying authority to begin that process.

Notably, the article provides some flexibility for bodies already designated under other EU harmonisation legislation, allowing existing documents and certificates to support their application here.

Important points:

Conformity assessment bodies must submit a detailed application to the national notifying authority in the Member State where they are established, including a description of their activities and the types of AI systems they are competent to assess.
Where an accreditation certificate exists, it must accompany the application; where it does not, the body must supply alternative documentary evidence sufficient to verify compliance with Article 31.
Conformity assessment bodies already designated under other Union harmonisation legislation can reuse those existing documents and certificates, but must keep all documentation up to date whenever relevant changes occur.

1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established.
1. 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.
2. Any valid document related to existing designations of the applicant notified body under any other Union harmonisation legislation shall be added.
1. 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.
1. 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.