in force 2026-07-27 MODIFIED+366 −5§
Amended by Digital Omnibus on AI 32026R1744
applies from: unchanged
In paragraph 4, the phrase describing designation under other Union harmonisation legislation changed from "under" to "pursuant to", and the purpose of reusing existing documents and certificates was expanded to also include expediting the designation procedure, not only supporting it.
A new paragraph was inserted requiring notified bodies designated pursuant to Union harmonisation legislation listed in Section A of Annex I, which undergo the unified assessment procedure referred to in Article 28(8), to submit a single application for assessment to the notifying authority designated pursuant to that legislation.
The remaining sentence on updating documentation under paragraphs 2 and 3 whenever relevant changes occur is retained, now positioned after the newly added text.
Cited: Art. 29, v1 · Art. 29, v2
text before / after
32024R1689 → 02024R1689-20260727
Article 29
Application of a conformity assessment body 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.
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.
4. For notified bodies which are designated under pursuant to any other Union harmonisation legislation, all documents and certificates linked to those designations may be used to support and expedite their designation procedure under this Regulation, as appropriate. Notified bodies, which are designated pursuant to any of the Union harmonisation legislation listed in Section A of Annex I and which undergo the unified assessment procedure referred to in Article 28(8), shall submit the single application for assessment to the notifying authority designated pursuant to that Union harmonisation legislation.
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.