Article 29 Application of a conformity assessment body for notification
1.
1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established.
2.
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. Articles2
3.
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. Articles1
4.
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.
Drafting History 2 ▾
AI Omnibus 1 ▾
Case Law 0 ▾
Guidance 1 ▾
2021-04-21
Commission Proposal — COM(2021) 206 final
Article 29 — Obligations of users of high-risk AI systems
1. Users of high-risk AI systems shall use such systems in accordance with the instructions of use accompanying the systems, pursuant to paragraphs 2 and 5. 2. The obligations in paragraph 1 are without prejudice to other user obligations under Union or national law and to the user’s discretion in organising its own resources and activities for the purpose of implementing the human oversight measures indicated by the provider. 3. Without prejudice to paragraph 1, to the extent the user exercises control over the input data, that user shall ensure that input data is relevant in view of the intended purpose of the high-risk AI system. 4. Users shall monitor the operation of the high-risk AI system on the basis of the instructions of use. When they have reasons to consider that the use in accordance with the instructions of use may result in the AI system presenting a risk within the meaning of Article 65(1) they shall inform the provider or distributor and suspend the use of the system. They shall also inform the provider or distributor when they have identified any serious incident or any malfunctioning within the meaning of Article 62 and interrupt the use of the AI system. In case the user is not able to reach the provider, Article 62 shall apply mutatis mutandis. For users that are credit institutions regulated by Directive 2013/36/EU, the monitoring obligation set out in the first subparagraph shall be deemed to be fulfilled by complying with the rules on internal governance arrangements, processes and mechanisms pursuant to Article 74 of that Directive. 5. Users of high-risk AI systems shall keep the logs automatically generated by that high-risk AI system, to the extent such logs are under their control. The logs shall be kept for a period that is appropriate in the light of the intended purpose of the high-risk AI system and applicable legal obligations under Union or national law. Users that are credit institutions regulated by Directive 2013/36/EU shall maintain the logs as part of the documentation concerning internal governance arrangements, processes and mechanisms pursuant to Article 74 of that Directive. 6. Users of high-risk AI systems shall use the information provided under Article 13 to comply with their obligation to carry out a data protection impact assessment under Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, where applicable.
July 2024
Final Adopted Text — Regulation (EU) 2024/1689
Article 29 — Application of a conformity assessment body for notification
4 paragraph(s) · Current text shown above
Notified bodies designated under other harmonisation legislation may use documents/certificates to support AI Act designation; single assessment procedure for Annex I Section A bodies
COM(2025) 836 final — AI Omnibus Regulation
⚖
No case law referencing Article 29 yet.
As courts and enforcement authorities produce decisions interpreting this provision, they will appear here.