Article 31 Requirements relating to notified bodies


    1. A notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall be established under the national law of a Member State and shall have legal personality.

    1. Notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks, as well as suitable cybersecurity means cybersecurity as defined in Article 2, point (1), of Regulation (EU) 2019/881; requirements.

    1. The organisational structure, allocation of responsibilities, reporting lines and operation of notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall ensure confidence in their performance, and in the results of the conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; activities that the notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; conduct.

    1. Notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall be independent of the provider of a high-risk AI system in relation to which they perform conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; activities. Notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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 means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008;, or the use of such high-risk AI systems for personal purposes.

    1. Neither a conformity assessment body means a conformity assessment body as defined in Article 2, point (13), of Regulation (EC) No 765/2008;, its top-level management nor the personnel responsible for carrying out its conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; 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 means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; activities for which they are notified. This shall, in particular, apply to consultancy services.

    1. Notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall be organised and operated so as to safeguard the independence, objectivity and impartiality of their activities. Notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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.

    1. Notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall have documented procedures in place ensuring that their personnel, committees, subsidiaries means a subsidiary undertaking within the meaning of Article 2, point (10), and Article 22 of Directive 2013/34/EU;, 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 means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; activities, except when its disclosure is required by law. The staff of notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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 means the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoring; of the Member State in which their activities are carried out.

    1. Notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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.

    1. Notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall take out appropriate liability insurance for their conformity assessment means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled; 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 means the process of verifying whether the essential cybersecurity requirements set out in Annex I have been fulfilled;.

    1. Notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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 means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; themselves or on their behalf and under their responsibility.

    1. Notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; shall have sufficient internal competences to be able effectively to evaluate the tasks conducted by external parties on their behalf. The notified body means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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.

    1. Notified bodies means a conformity assessment body designated in accordance with Article 43 and other relevant Union harmonisation legislation; 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 means a standard as defined in Article 2, point (1), of Regulation (EU) No 1025/2012 of the European Parliament and of the Council (^29^); Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12)..

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We offer professional services concerning information security governance, risk and compliance.

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