AI Act, Article 31, SE

1. A notified body shall be established under the national law of a Member State and shall have legal personality.

2. Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks, as well as suitable cybersecurity requirements.

3. The organisational structure, allocation of responsibilities, reporting lines and operation of notified bodies shall ensure confidence in their performance, and in the results of the conformity assessment activities that the notified bodies conduct.

4. Notified bodies shall be independent of the provider of a high-risk AI system in relation to which they perform conformity assessment activities. Notified bodies shall also be independent of any other operator having an economic interest in high-risk AI systems assessed, as well as of any competitors of the provider. This shall not preclude the use of assessed high-risk AI systems that are necessary for the operations of the conformity assessment body, or the use of such high-risk AI systems for personal purposes.

5. Neither a conformity assessment body, its top-level management nor the personnel responsible for carrying out its conformity assessment tasks shall be directly involved in the design, development, marketing or use of high-risk AI systems, nor shall they represent the parties engaged in those activities. They shall not engage in any activity that might conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall, in particular, apply to consultancy services.

6. Notified bodies shall be organised and operated so as to safeguard the independence, objectivity and impartiality of their activities. Notified bodies shall document and implement a structure and procedures to safeguard impartiality and to promote and apply the principles of impartiality throughout their organisation, personnel and assessment activities.

7. Notified bodies shall have documented procedures in place ensuring that their personnel, committees, subsidiaries, subcontractors and any associated body or personnel of external bodies maintain, in accordance with Article 78, the confidentiality of the information which comes into their possession during the performance of conformity assessment activities, except when its disclosure is required by law. The staff of notified bodies shall be bound to observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the notifying authorities of the Member State in which their activities are carried out.

8. Notified bodies shall have procedures for the performance of activities which take due account of the size of a provider, the sector in which it operates, its structure, and the degree of complexity of the AI system concerned.

9. Notified bodies shall take out appropriate liability insurance for their conformity assessment activities, unless liability is assumed by the Member State in which they are established in accordance with national law or that Member State is itself directly responsible for the conformity assessment.

10. Notified bodies shall be capable of carrying out all their tasks under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by notified bodies themselves or on their behalf and under their responsibility.

11. Notified bodies shall have sufficient internal competences to be able effectively to evaluate the tasks conducted by external parties on their behalf. The notified body shall have permanent availability of sufficient administrative, technical, legal and scientific personnel who possess experience and knowledge relating to the relevant types of AI systems, data and data computing, and relating to the requirements set out in Section 2.

12. Notified bodies shall participate in coordination activities as referred to in Article 38. They shall also take part directly, or be represented in, European standardisation organisations, or ensure that they are aware and up to date in respect of relevant standards.

Official source

Version: bba826b483642c92

SHA-256: sha256:bba826b483642c92eef09638556e32abab9f8db1601484979139289c31e6f370

• Article 1
• Article 2
• Article 3
• Article 4
• Article 5
• Article 6
• Article 7
• Article 8
• Article 9
• Article 10
• Article 11
• Article 12
• Article 13
• Article 14
• Article 15
• Article 16
• Article 17
• Article 18
• Article 19
• Article 20
• Article 21
• Article 22
• Article 23
• Article 24
• Article 25
• Article 26
• Article 27
• Article 28
• Article 29
• Article 30
• Article 32
• Article 33
• Article 34
• Article 35
• Article 36
• Article 37
• Article 38
• Article 39
• Article 40
• Article 41
• Article 42
• Article 43
• Article 44
• Article 45
• Article 46
• Article 47
• Article 48
• Article 49
• Article 50
• Article 51
• Article 52
• Article 53
• Article 54
• Article 55
• Article 56
• Article 57
• Article 58
• Article 59
• Article 60
• Article 61
• Article 62
• Article 63
• Article 64
• Article 65
• Article 66
• Article 67
• Article 68
• Article 69
• Article 70
• Article 71
• Article 72
• Article 73
• Article 74
• Article 75
• Article 76
• Article 77
• Article 78
• Article 79
• Article 80
• Article 81
• Article 82
• Article 83
• Article 84
• Article 85
• Article 86
• Article 87
• Article 88
• Article 89
• Article 90
• Article 91
• Article 92
• Article 93
• Article 94
• Article 95
• Article 96
• Article 97
• Article 98
• Article 99
• Article 100
• Article 101
• Article 102
• Article 103
• Article 104
• Article 105
• Article 106
• Article 107
• Article 108
• Article 109
• Article 110
• Article 111
• Article 112
• Article 113

Geographical article agents

Source: NovaCopilot