jeroenherczeg/eu-ai-act huggingface dataset:
Art. 26(11) AI Act

Without prejudice to Article 50 of this Regulation, deployers of high-risk AI systems referred to in Annex III that make decisions or assist in making decisions related to natural persons shall inform the natural persons that they are subject to the use of the high-risk AI system. For high-risk AI systems used for law enforcement purposes Article 13 of Directive (EU) 2016/680 shall apply.
Art. 26(12) AI Act

Deployers shall cooperate with the relevant competent authorities in any action those authorities take in relation to the high-risk AI system in order to implement this Regulation.
Art. 27 AI Act

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.
Art. 27(1) AI Act

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.
Art. 27(2) AI Act

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.
Art. 27(3) AI Act

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.
Art. 27(4) AI Act

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.
Art. 27(5) AI Act

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.
Art. 28 AI Act

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.
Art. 28(1) AI Act

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.
Art. 28(2) AI Act

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.
Art. 28(3) AI Act

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.
Art. 28(4) AI Act

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.
Art. 28(5) AI Act

Notifying authorities shall offer or provide neither any activities that conformity assessment bodies perform, nor any consultancy services on a commercial or competitive basis.
Art. 28(6) AI Act

Notifying authorities shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
Art. 28(7) AI Act

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.
Art. 29 AI Act

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.
Art. 29(1) AI Act

Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established.
Art. 29(2) AI Act

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.
Art. 29(3) AI Act

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.
Art. 29(4) AI Act

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.
Art. 30 AI Act

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.
Art. 30(1) AI Act

Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 31.
Art. 30(2) AI Act

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.
Art. 30(3) AI Act

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.
Art. 30(4) AI Act

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).
Art. 30(5) AI Act

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.
Art. 31(1) AI Act

A notified body shall be established under the national law of a Member State and shall have legal personality.
Art. 31(2) AI Act

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.
Art. 31(3) AI Act

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.
Art. 31(4) AI Act

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.
Art. 31(5) AI Act

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.
Art. 31(6) AI Act

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.
Art. 31(7) AI Act

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.
Art. 31(8) AI Act

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.
Art. 31(9) AI Act

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.
Art. 31(10) AI Act

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.
Art. 31(11) AI Act

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.
Art. 31(12) AI Act

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.
Art. 32 AI Act

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.
Art. 32 AI Act

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.
Art. 33 AI Act

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.
Art. 33(1) AI Act

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.
Art. 33(2) AI Act

Notified bodies shall take full responsibility for the tasks performed by any subcontractors or subsidiaries.
Art. 33(3) AI Act

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.
Art. 33(4) AI Act

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.