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Article 31

Requirements relating to notified bodies

https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32024R1689#art_31 ↗
Notified Bodies Article 31(2)

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

Show source text · Article 31(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.
Notified Bodies Article 31(3)

Notified bodies must ensure confidence in their performance, and in the results of the conformity assessment activities that they conduct.

Show source text · Article 31(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.
Notified Bodies Article 31(4)

Notified bodies must be independent of the provider of a high-risk AI system in relation to which they perform conformity assessment activities.

Show source text · Article 31(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 Article 31(6)

Notified bodies must be organised and operated so as to safeguard the independence, objectivity and impartiality of their activities.

Show source text · Article 31(6)
Notified bodies shall be organised and operated so as to safeguard the independence, objectivity and impartiality of their activities.
Notified Bodies Article 31(6)

Notified bodies must 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.

Show source text · Article 31(6)
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.
Notified Bodies Article 31(7)

Notified bodies must have documented procedures in place ensuring that their personnel, committees, subsidiaries, subcontractors and any associated body or personnel of external bodies maintain the confidentiality of the information which comes into their possession during the performance of conformity assessment activities.

Show source text · Article 31(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.
Notified Bodies Article 31(7)

The staff of notified bodies must observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation.

Show source text · Article 31(7)
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

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