laredoyin/eu-ai-act huggingface dataset:
Chapter III: HIGH-RISK AI SYSTEMS
Section 3: Obligations of providers and deployers of high-risk AI systems and other parties
Article 27: Fundamental rights impact assessment for high-risk AI systems

1. Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems  intended to be used in the area listed in point 2 of Annex III, deployers that are bodies governed by public law, or are private  entities providing public services, and deployers of high-risk AI systems referred to in points 5 (b) and (c) of Annex III, shall  perform an assessment of the impact on fundamental rights that the use of such system may produce. For that purpose,  deployers shall perform an assessment consisting of:(a) a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;(b) a description of the period of time within which, and the frequency with which, each high-risk AI system is intended to  be used;(c) the categories of natural persons and groups likely to be affected by its use in the specific context;(d) the specific risks of harm likely to have an impact on the categories of natural persons or groups of persons identified  pursuant to point (c) of this paragraph, taking into account the information given by the provider pursuant to  Article 13;(e) a description of the implementation of human oversight measures, according to the instructions for use;(f) the measures to be taken in the case of the materialisation of those risks, including the arrangements for internal  governance and complaint mechanisms. 2. The obligation laid down in paragraph 1 applies to the first use of the high-risk AI system. The deployer may, in  similar cases, rely on previously conducted fundamental rights impact assessments or existing impact assessments carried  out by provider. If, during the use of the high-risk AI system, the deployer considers that any of the elements listed in  paragraph 1 has changed or is no longer up to date, the deployer shall take the necessary steps to update the information. 3. Once the assessment referred to in paragraph 1 of this Article has been performed, the deployer shall notify the  market surveillance authority of its results, submitting the filled-out template referred to in paragraph 5 of this Article as  part of the notification. In the case referred to in Article 46(1), deployers may be exempt from that obligation to notify. 4. If any of the obligations laid down in this Article is already met through the data protection impact assessment  conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the fundamental  rights impact assessment referred to in paragraph 1 of this Article shall complement that data protection impact  assessment. 5. The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers  in complying with their obligations under this Article in a simplified manner.
Chapter III: HIGH-RISK AI SYSTEMS
Section 4: Notifying authorities and notified bodies
Article 28: Notifying authorities

1. Each Member State shall designate or establish at least one notifying 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. Those procedures shall be developed in cooperation between the notifying authorities of all Member States. 2. Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by  a national accreditation body within the meaning of, and in accordance with, Regulation (EC) No 765/2008. 3. Notifying authorities shall be established, organised and operated in such a way that no conflict of interest arises with  conformity assessment bodies, and that the objectivity and impartiality of their activities are safeguarded. 4. Notifying authorities shall be organised in such a way that decisions relating to the notification of conformity  assessment bodies are taken by competent persons different from those who carried out the assessment of those bodies. 5. Notifying authorities shall offer or provide neither any activities that conformity assessment bodies perform, nor any  consultancy services on a commercial or competitive basis. 6. Notifying authorities shall safeguard the confidentiality of the information that they obtain, in accordance with  Article 78. 7. Notifying authorities shall have an adequate number of competent personnel at their disposal for the proper  performance of their tasks. Competent personnel shall have the necessary expertise, where applicable, for their function, in  fields such as information technologies, AI and law, including the supervision of fundamental rights.
Chapter III: HIGH-RISK AI SYSTEMS
Section 4: Notifying authorities and notified bodies
Article 29: Application of a conformity assessment body for notification

1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member  State in which they are established. 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. 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. 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.
Chapter III: HIGH-RISK AI SYSTEMS
Section 4: Notifying authorities and notified bodies
Article 30: Notification procedure

1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 31. 2. Notifying authorities shall notify the Commission and the other Member States, using the electronic notification tool developed and managed by the Commission, of each conformity assessment body referred to in paragraph 1. 3. The notification referred to in paragraph 2 of this Article shall include full details of the conformity assessment activities, the conformity assessment module or modules, the types of AI systems concerned, and the relevant attestation of competence. Where a notification is not based on an accreditation certificate as referred to in Article 29(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the competence of the conformity assessment body and to the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 31. 4. The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification by a notifying authority where it includes an accreditation certificate referred to in Article 29(2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in Article 29(3). 5. Where objections are raised, the Commission shall, without delay, enter into consultations with the relevant Member States and the conformity assessment body. In view thereof, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant conformity assessment body.
Chapter III: HIGH-RISK AI SYSTEMS
Section 4: Notifying authorities and notified bodies
Article 32: Presumption of conformity with requirements relating to notified bodies

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 31 in so far as the applicable harmonised standards cover those requirements.
Chapter III: HIGH-RISK AI SYSTEMS
Section 4: Notifying authorities and notified bodies
Article 33: Subsidiaries of notified bodies and subcontracting

1. Where a notified body subcontracts specific tasks connected with the conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements laid down in Article 31, and shall inform the notifying authority accordingly. 2. Notified bodies shall take full responsibility for the tasks performed by any subcontractors or subsidiaries. 3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. Notified bodies shall make a list of their subsidiaries publicly available. 4. The relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation shall be kept at the disposal of the notifying authority for a period of five years from the termination date of the subcontracting.
Chapter III: HIGH-RISK AI SYSTEMS
Section 4: Notifying authorities and notified bodies
Article 34: Operational obligations of notified bodies

1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43. 2. Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account of the size of the provider, the sector in which it operates, its structure and the degree of complexity of the high-risk AI system concerned, in particular in view of minimising administrative burdens and compliance costs for micro- and small enterprises within the meaning of Recommendation 2003/361/EC. The notified body shall, nevertheless, respect the degree of rigour and the level of protection required for the compliance of the high-risk AI system with the requirements of this Regulation. 3. Notified bodies shall make available and submit upon request all relevant documentation, including the provider's documentation, to the notifying authority referred to in Article 28 to allow that authority to conduct its assessment, designation, notification and monitoring activities, and to facilitate the assessment outlined in this Section.
Chapter III: HIGH-RISK AI SYSTEMS
Section 4: Notifying authorities and notified bodies
Article 35: Identification numbers and lists of notified bodies

1. The Commission shall assign a single identification number to each notified body, even where a body is notified under more than one Union act. 2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including their identification numbers and the activities for which they have been notified. The Commission shall ensure that the list is kept up to date.
Chapter III: HIGH-RISK AI SYSTEMS
Section 4: Notifying authorities and notified bodies
Article 37: Challenge to the competence of notified bodies

1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment by a notified body of the requirements laid down in Article 31 and of its applicable responsibilities. 2. The notifying authority shall provide the Commission, on request, with all relevant information relating to the notification or the maintenance of the competence of the notified body concerned. 3. The Commission shall ensure that all sensitive information obtained in the course of its investigations pursuant to this Article is treated confidentially in accordance with Article 78. 4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension or withdrawal of the notification if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
Chapter III: HIGH-RISK AI SYSTEMS
Section 4: Notifying authorities and notified bodies
Article 38: Coordination of notified bodies

1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation between notified bodies active in the conformity assessment procedures pursuant to this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies. 2. Each notifying authority shall ensure that the bodies notified by it participate in the work of a group referred to in paragraph 1, directly or through designated representatives. 3. The Commission shall provide for the exchange of knowledge and best practices between notifying authorities.
Chapter III: HIGH-RISK AI SYSTEMS
Section 5: Standards, conformity assessment, certificates, registration
Article 40: Harmonised standards and standardisation deliverables

1. High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements set out in Section 2 of this Chapter or, as applicable, with the obligations set out in of Chapter V, Sections 2 and 3, of this Regulation, to the extent that those standards cover those requirements or obligations. 2. In accordance with Article 10 of Regulation (EU) No 1025/2012, the Commission shall issue, without undue delay, standardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, standardisation requests covering obligations set out in Chapter V, Sections 2 and 3, of this Regulation. The standardisation request shall also ask for deliverables on reporting and documentation processes to improve AI systems' resource performance, such as reducing the high-risk AI system's consumption of energy and of other resources during its lifecycle, and on the energy-efficient development of general-purpose AI models. When preparing a standardisation request, the Commission shall consult the Board and relevant stakeholders, including the advisory forum. When issuing a standardisation request to European standardisation organisations, the Commission shall specify that standards have to be clear, consistent, including with the standards developed in the various sectors for products covered by the existing Union harmonisation legislation listed in Annex I, and aiming to ensure that high-risk AI systems or general-purpose AI models placed on the market or put into service in the Union meet the relevant requirements or obligations laid down in this Regulation. The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil the objectives referred to in the first and the second subparagraph of this paragraph in accordance with Article 24 of Regulation (EU) No 1025/2012. 3. The participants in the standardisation process shall seek to promote investment and innovation in AI, including through increasing legal certainty, as well as the competitiveness and growth of the Union market, to contribute to strengthening global cooperation on standardisation and taking into account existing international standards in the field of AI that are consistent with Union values, fundamental rights and interests, and to enhance multi-stakeholder governance ensuring a balanced representation of interests and the effective participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of Regulation (EU) No 1025/2012.
Chapter III: HIGH-RISK AI SYSTEMS
Section 5: Standards, conformity assessment, certificates, registration
Article 42: Presumption of conformity with certain requirements

1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which they are intended to be used shall be presumed to comply with the relevant requirements laid down in Article 10(4). 2. High-risk AI systems that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 and the references of which have been published in the Official Journal of the European Union shall be presumed to comply with the cybersecurity requirements set out in Article 15 of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those requirements.
Chapter III: HIGH-RISK AI SYSTEMS
Section 5: Standards, conformity assessment, certificates, registration
Article 44: Certificates

1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a language which can be easily understood by the relevant authorities in the Member State in which the notified body is established. 2. Certificates shall be valid for the period they indicate, which shall not exceed five years for AI systems covered by Annex I, and four years for AI systems covered by Annex III. At the request of the provider, the validity of a certificate may be extended for further periods, each not exceeding five years for AI systems covered by Annex I, and four years for AI systems covered by Annex III, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid, provided that the certificate which it supplements is valid. 3. Where a notified body finds that an AI system no longer meets the requirements set out in Section 2, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose restrictions on it, unless compliance with those requirements is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The notified body shall give reasons for its decision. An appeal procedure against decisions of the notified bodies, including on conformity certificates issued, shall be available.
Chapter III: HIGH-RISK AI SYSTEMS
Section 5: Standards, conformity assessment, certificates, registration
Article 45: Information obligations of notified bodies

1. Notified bodies shall inform the notifying authority of the following:(a)any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;(b)any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality management system approval issued in accordance with the requirements of Annex VII;(c)any circumstances affecting the scope of or conditions for notification;(d)any request for information which they have received from market surveillance authorities regarding conformity assessment activities;(e)on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting. 2. Each notified body shall inform the other notified bodies of:(a)quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;(b)Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued. 3. Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities  covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive  conformity assessment results. 4. Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
Chapter III: HIGH-RISK AI SYSTEMS
Section 5: Standards, conformity assessment, certificates, registration
Article 47: EU declaration of conformity

1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity  for each high-risk AI system, and keep it at the disposal of the national competent authorities for 10 years after the  high-risk AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the  high-risk AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be submitted to the  relevant national competent authorities upon request. 2. The EU declaration of conformity shall state that the high-risk AI system concerned meets the requirements set out in  Section 2. The EU declaration of conformity shall contain the information set out in Annex V, and shall be translated into  a language that can be easily understood by the national competent authorities of the Member States in which the high-risk  AI system is placed on the market or made available. 3. Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU  declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union law applicable to  the high-risk AI system. The declaration shall contain all the information required to identify the Union harmonisation  legislation to which the declaration relates. 4. By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the  requirements set out in Section 2. The provider shall keep the EU declaration of conformity up-to-date as appropriate. 5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex V by  updating the content of the EU declaration of conformity set out in that Annex, in order to introduce elements that become  necessary in light of technical progress.