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.
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-
Notified bodies must ensure confidence in their performance, and in the results of the conformity assessment activities that they conduct.
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-
Notified bodies must be independent of the provider of a high-risk AI system in relation to which they perform conformity assessment activities.
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-
Notified bodies must be organised and operated so as to safeguard the independence, objectivity and impartiality of their activities.
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-
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.
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-
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.
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-
The staff of notified bodies must observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation.
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-
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