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384
Article 56
1. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level in order to contribute to the proper application of this Regulation, taking into account international approaches. 2. The AI Office and the Board shall aim to ensure that the codes of practice cover at least the oblig...
office shall encourage facilitate drawing code practice union level order contribute proper application regulation taking account international approach office board shall aim ensure code practice cover least obligation provided article including following issue mean ensure information referred article point kept date ...
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all-MiniLM-L6-v2
384
Article 51
1. A general-purpose AI model shall be classified as a general-purpose AI model with systemic risk if it meets any of the following conditions: (a) it has high impact capabilities evaluated on the basis of appropriate technical tools and methodologies, including indicators and benchmarks; (a) it has high impact capab...
general purpose model shall classified general purpose model systemic risk meet following condition high impact capability evaluated basis appropriate technical tool methodology including indicator benchmark high impact capability evaluated basis appropriate technical tool methodology including indicator benchmark base...
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all-MiniLM-L6-v2
384
Article 52
1. Where a general-purpose AI model meets the condition referred to in Article 51(1), point (a), the relevant provider shall notify the Commission without delay and in any event within two weeks after that requirement is met or it becomes known that it will be met. That notification shall include the information nece...
general purpose model meet condition referred article point relevant provider shall notify commission without delay event within two week requirement met becomes known met notification shall include information necessary demonstrate relevant requirement met commission becomes aware general purpose model presenting syst...
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all-MiniLM-L6-v2
384
Article 53
1. Providers of general-purpose AI models shall: (a) draw up and keep up-to-date the technical documentation of the model, including its training and testing process and the results of its evaluation, which shall contain, at a minimum, the information set out in Annex XI for the purpose of providing it, upon request,...
provider general purpose model shall draw keep date technical documentation model including training testing process result evaluation shall contain minimum information set annex purpose providing upon request office national competent authority draw keep date technical documentation model including training testing pr...
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all-MiniLM-L6-v2
384
Article 54
1. Prior to placing a general-purpose AI model on the Union market, providers established in third countries shall, by written mandate, appoint an authorised representative which is established in the Union. 2. The provider shall enable its authorised representative to perform the tasks specified in the mandate rec...
prior placing general purpose model union market provider established third country shall written mandate appoint authorised representative established union provider shall enable authorised representative perform task specified mandate received provider authorised representative shall perform task specified mandate re...
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384
Article 55
1. In addition to the obligations listed in Articles 53 and 54, providers of general-purpose AI models with systemic risk shall: (a) perform model evaluation in accordance with standardised protocols and tools reflecting the state of the art, including conducting and documenting adversarial testing of the model with ...
addition obligation listed article provider general purpose model systemic risk shall perform model evaluation accordance standardised protocol tool reflecting state art including conducting documenting adversarial testing model view identifying mitigating systemic risk perform model evaluation accordance standardised ...
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all-MiniLM-L6-v2
384
Article 56
1. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level in order to contribute to the proper application of this Regulation, taking into account international approaches. 2. The AI Office and the Board shall aim to ensure that the codes of practice cover at least the oblig...
office shall encourage facilitate drawing code practice union level order contribute proper application regulation taking account international approach office board shall aim ensure code practice cover least obligation provided article including following issue mean ensure information referred article point kept date ...
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384
Article 57
1. Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national level, which shall be operational by 2 August 2026. That sandbox may also be established jointly with the competent authorities of other Member States. The Commission may provide technical support, ...
member state shall ensure competent authority establish least one regulatory sandbox national level shall operational august 2026 sandbox may also established jointly competent authority member state commission may provide technical support advice tool establishment operation regulatory sandbox obligation first subpara...
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all-MiniLM-L6-v2
384
Article 58
1. In order to avoid fragmentation across the Union, the Commission shall adopt implementing acts specifying the detailed arrangements for the establishment, development, implementation, operation and supervision of the AI regulatory sandboxes. The implementing acts shall include common principles on the following is...
order avoid fragmentation across union commission shall adopt implementing act specifying detailed arrangement establishment development implementation operation supervision regulatory sandbox implementing act shall include common principle following issue eligibility selection criterion participation regulatory sandbo...
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384
Article 59
1. In the AI regulatory sandbox, personal data lawfully collected for other purposes may be processed solely for the purpose of developing, training and testing certain AI systems in the sandbox when all of the following conditions are met: (a) AI systems shall be developed for safeguarding substantial public interes...
regulatory sandbox personal data lawfully collected purpose may processed solely purpose developing training testing certain system sandbox following condition met system shall developed safeguarding substantial public interest public authority another natural legal person one following area public safety public health...
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all-MiniLM-L6-v2
384
Article 60
1. Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by providers or prospective providers of high-risk AI systems listed in Annex III, in accordance with this Article and the real-world testing plan referred to in this Article, without prejudice to the prohibit...
testing high risk system real world condition outside regulatory sandbox may conducted provider prospective provider high risk system listed annex iii accordance article real world testing plan referred article without prejudice prohibition article commission shall mean implementing act specify detailed element real wo...
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all-MiniLM-L6-v2
384
Article 61
1. For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding: (a) the ...
purpose testing real world condition article freely given informed consent shall obtained subject testing prior participation testing duly informed concise clear relevant understandable information regarding nature objective testing real world condition possible inconvenience may linked participation nature objective t...
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all-MiniLM-L6-v2
384
Article 62
1. Member States shall undertake the following actions: (a) provide SMEs, including start-ups, having a registered office or a branch in the Union, with priority access to the AI regulatory sandboxes, to the extent that they fulfil the eligibility conditions and selection criteria; the priority access shall not precl...
member state shall undertake following action provide smes including start ups registered office branch union priority access regulatory sandbox extent fulfil eligibility condition selection criterion priority access shall preclude smes including start ups referred paragraph access regulatory sandbox provided also fulf...
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all-MiniLM-L6-v2
384
Article 63
1. Microenterprises within the meaning of Recommendation 2003/361/EC may comply with certain elements of the quality management system required by Article 17 of this Regulation in a simplified manner, provided that they do not have partner enterprises or linked enterprises within the meaning of that Recommendation. F...
microenterprises within meaning recommendation 2003 361 may comply certain element quality management system required article regulation simplified manner provided partner enterprise linked enterprise within meaning recommendation purpose commission shall develop guideline element quality management system may complied...
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all-MiniLM-L6-v2
384
Article 64
1. The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office. 2. Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.
commission shall develop union expertise capability field office member state shall facilitate task entrusted office reflected regulation
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384
Article 65
1. A European Artificial Intelligence Board (the β€˜Board’) is hereby established. 2. The Board shall be composed of one representative per Member State. The European Data Protection Supervisor shall participate as observer. The AI Office shall also attend the Board’s meetings, without taking part in the votes. Other...
european artificial intelligence board board hereby established board shall composed one representative per member state european data protection supervisor shall participate observer office shall also attend board meeting without taking part vote national union authority body expert may invited meeting board case case...
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all-MiniLM-L6-v2
384
Article 66
The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective application of this Regulation. To that end, the Board may in particular: (a) contribute to the coordination among national competent authorities responsible for the application of this Regulation ...
board shall advise assist commission member state order facilitate consistent effective application regulation end board may particular contribute coordination among national competent authority responsible application regulation cooperation subject agreement market surveillance authority concerned support joint activi...
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all-MiniLM-L6-v2
384
Article 67
1. An advisory forum shall be established to provide technical expertise and advise the Board and the Commission, and to contribute to their tasks under this Regulation. 2. The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry, start-ups, SMEs, civil society a...
advisory forum shall established provide technical expertise advise board commission contribute task regulation membership advisory forum shall represent balanced selection stakeholder including industry start ups smes civil society academia membership advisory forum shall balanced regard commercial non commercial inte...
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all-MiniLM-L6-v2
384
Article 68
1. The Commission shall, by means of an implementing act, make provisions on the establishment of a scientific panel of independent experts (the β€˜scientific panel’) intended to support the enforcement activities under this Regulation. That implementing act shall be adopted in accordance with the examination procedure...
commission shall mean implementing act make provision establishment scientific panel independent expert scientific panel intended support enforcement activity regulation implementing act shall adopted accordance examination procedure referred article scientific panel shall consist expert selected commission basis date ...
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all-MiniLM-L6-v2
384
Article 69
1. Member States may call upon experts of the scientific panel to support their enforcement activities under this Regulation. 2. The Member States may be required to pay fees for the advice and support provided by the experts. The structure and the level of fees as well as the scale and structure of recoverable cos...
member state may call upon expert scientific panel support enforcement activity regulation member state may required pay fee advice support provided expert structure level fee well scale structure recoverable cost shall set implementing act referred article taking account objective adequate implementation regulation co...
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all-MiniLM-L6-v2
384
Article 70
1. Each Member State shall establish or designate as national competent authorities at least one notifying authority and at least one market surveillance authority for the purposes of this Regulation. Those national competent authorities shall exercise their powers independently, impartially and without bias so as to...
member state shall establish designate national competent authority least one notifying authority least one market surveillance authority purpose regulation national competent authority shall exercise power independently impartially without bias safeguard objectivity activity task ensure application implementation regu...
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all-MiniLM-L6-v2
384
Article 64
1. The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office. 2. Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.
commission shall develop union expertise capability field office member state shall facilitate task entrusted office reflected regulation
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all-MiniLM-L6-v2
384
Article 65
1. A European Artificial Intelligence Board (the β€˜Board’) is hereby established. 2. The Board shall be composed of one representative per Member State. The European Data Protection Supervisor shall participate as observer. The AI Office shall also attend the Board’s meetings, without taking part in the votes. Other...
european artificial intelligence board board hereby established board shall composed one representative per member state european data protection supervisor shall participate observer office shall also attend board meeting without taking part vote national union authority body expert may invited meeting board case case...
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all-MiniLM-L6-v2
384
Article 66
The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective application of this Regulation. To that end, the Board may in particular: (a) contribute to the coordination among national competent authorities responsible for the application of this Regulation ...
board shall advise assist commission member state order facilitate consistent effective application regulation end board may particular contribute coordination among national competent authority responsible application regulation cooperation subject agreement market surveillance authority concerned support joint activi...
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all-MiniLM-L6-v2
384
Article 67
1. An advisory forum shall be established to provide technical expertise and advise the Board and the Commission, and to contribute to their tasks under this Regulation. 2. The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry, start-ups, SMEs, civil society a...
advisory forum shall established provide technical expertise advise board commission contribute task regulation membership advisory forum shall represent balanced selection stakeholder including industry start ups smes civil society academia membership advisory forum shall balanced regard commercial non commercial inte...
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all-MiniLM-L6-v2
384
Article 68
1. The Commission shall, by means of an implementing act, make provisions on the establishment of a scientific panel of independent experts (the β€˜scientific panel’) intended to support the enforcement activities under this Regulation. That implementing act shall be adopted in accordance with the examination procedure...
commission shall mean implementing act make provision establishment scientific panel independent expert scientific panel intended support enforcement activity regulation implementing act shall adopted accordance examination procedure referred article scientific panel shall consist expert selected commission basis date ...
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all-MiniLM-L6-v2
384
Article 69
1. Member States may call upon experts of the scientific panel to support their enforcement activities under this Regulation. 2. The Member States may be required to pay fees for the advice and support provided by the experts. The structure and the level of fees as well as the scale and structure of recoverable cos...
member state may call upon expert scientific panel support enforcement activity regulation member state may required pay fee advice support provided expert structure level fee well scale structure recoverable cost shall set implementing act referred article taking account objective adequate implementation regulation co...
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all-MiniLM-L6-v2
384
Article 70
1. Each Member State shall establish or designate as national competent authorities at least one notifying authority and at least one market surveillance authority for the purposes of this Regulation. Those national competent authorities shall exercise their powers independently, impartially and without bias so as to...
member state shall establish designate national competent authority least one notifying authority least one market surveillance authority purpose regulation national competent authority shall exercise power independently impartially without bias safeguard objectivity activity task ensure application implementation regu...
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all-MiniLM-L6-v2
384
Article 71
1. The Commission shall, in collaboration with the Member States, set up and maintain an EU database containing information referred to in paragraphs 2 and 3 of this Article concerning high-risk AI systems referred to in Article 6(2) which are registered in accordance with Articles 49 and 60 and AI systems that are n...
commission shall collaboration member state set maintain database containing information referred paragraph article concerning high risk system referred article registered accordance article system considered high risk pursuant article registered accordance article article setting functional specification database comm...
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all-MiniLM-L6-v2
384
Article 72
1. Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the AI technologies and the risks of the high-risk AI system. 2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data which may be p...
provider shall establish document post market monitoring system manner proportionate nature technology risk high risk system post market monitoring system shall actively systematically collect document analyse relevant data may provided deployers may collected source performance high risk system throughout lifetime all...
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384
Article 73
1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred. 2. The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link between the ...
provider high risk system placed union market shall report serious incident market surveillance authority member state incident occurred report referred paragraph shall made immediately provider established causal link system serious incident reasonable likelihood link event later day provider applicable deployer becom...
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384
Article 74
1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective enforcement of this Regulation: (a) any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation; (...
regulation 2019 1020 shall apply system covered regulation purpose effective enforcement regulation reference economic operator regulation 2019 1020 shall understood including operator identified article regulation reference economic operator regulation 2019 1020 shall understood including operator identified article r...
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all-MiniLM-L6-v2
384
Article 75
1. Where an AI system is based on a general-purpose AI model, and the model and the system are developed by the same provider, the AI Office shall have powers to monitor and supervise compliance of that AI system with obligations under this Regulation. To carry out its monitoring and supervision tasks, the AI Office ...
system based general purpose model model system developed provider office shall power monitor supervise compliance system obligation regulation carry monitoring supervision task office shall power market surveillance authority provided section regulation 2019 1020 relevant market surveillance authority sufficient reaso...
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all-MiniLM-L6-v2
384
Article 76
1. Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in accordance with this Regulation. 2. Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory sandbox under Article 58, the market surveilla...
market surveillance authority shall competence power ensure testing real world condition accordance regulation testing real world condition conducted system supervised within regulatory sandbox article market surveillance authority shall verify compliance article part supervisory role regulatory sandbox authority may a...
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all-MiniLM-L6-v2
384
Article 77
1. National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights, including the right to non-discrimination, in relation to the use of high-risk AI systems referred to in Annex III shall have the power to request and access any documentation ...
national public authority body supervise enforce respect obligation union law protecting fundamental right including right non discrimination relation use high risk system referred annex iii shall power request access documentation created maintained regulation accessible language format access documentation necessary ...
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all-MiniLM-L6-v2
384
Article 78
1. The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a...
commission market surveillance authority notified body natural legal person involved application regulation shall accordance union national law respect confidentiality information data obtained carrying task activity manner protect particular intellectual property right confidential business information trade secret na...
[ -0.03794500231742859, 0.06875584274530411, -0.08093656599521637, -0.04967844486236572, 0.08054838329553604, 0.07939744740724564, 0.06249719113111496, -0.012641672044992447, 0.008348612114787102, -0.007313739042729139, 0.02645943872630596, -0.002153867855668068, -0.013364190235733986, -0.04...
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384
Article 79
1. AI systems presenting a risk shall be understood as a β€˜product presenting a risk’ as defined in Article 3, point 19 of Regulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights, of persons. 2. Where the market surveillance authority of a Member State has suffici...
system presenting risk shall understood product presenting risk defined article point regulation 2019 1020 far present risk health safety fundamental right person market surveillance authority member state sufficient reason consider system present risk referred paragraph article shall carry evaluation system concerned ...
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all-MiniLM-L6-v2
384
Article 80
1. Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of the AI system concerned in respect of its classification as a high-r...
market surveillance authority sufficient reason consider system classified provider non high risk pursuant article indeed high risk market surveillance authority shall carry evaluation system concerned respect classification high risk system based condition set article commission guideline course evaluation market surv...
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384
Article 81
1. Where, within three months of receipt of the notification referred to in Article 79(5), or within 30 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, objections are raised by the market surveillance authority of a Member State to a measure taken by another marke...
within three month receipt notification referred article within day case non compliance prohibition practice referred article objection raised market surveillance authority member state measure taken another market surveillance authority commission considers measure contrary union law commission shall without undue del...
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all-MiniLM-L6-v2
384
Article 82
1. Where, having performed an evaluation under Article 79, after consulting the relevant national public authority referred to in Article 77(1), the market surveillance authority of a Member State finds that although a high-risk AI system complies with this Regulation, it nevertheless presents a risk to the health or...
performed evaluation article consulting relevant national public authority referred article market surveillance authority member state find although high risk system complies regulation nevertheless present risk health safety person fundamental right aspect public interest protection shall require relevant operator tak...
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384
Article 83
1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned, within a period it may prescribe: (a) the CE marking has been affixed in violation of Article 48; (a) the CE marking has been affixed ...
market surveillance authority member state make one following finding shall require relevant provider put end non compliance concerned within period may prescribe marking affixed violation article marking affixed violation article marking affixed marking affixed declaration conformity referred article drawn declaration...
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384
Article 84
1. The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under Article 21(6) of Regulation (EU) 2019/1020 in the area of AI. 2. Without prejudice to the tasks referred to in paragraph 1, Union AI testing support structures shall also provide independent technical...
commission shall designate one union testing support structure perform task listed article regulation 2019 1020 area without prejudice task referred paragraph union testing support structure shall also provide independent technical scientific advice request board commission market surveillance authority
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all-MiniLM-L6-v2
384
Article 85
Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that there has been an infringement of the provisions of this Regulation may submit complaints to the relevant market surveillance authority. In accordance with Regulation (EU) 2019/1020, such complain...
without prejudice administrative judicial remedy natural legal person ground consider infringement provision regulation may submit complaint relevant market surveillance authority accordance regulation 2019 1020 complaint shall taken account purpose conducting market surveillance activity shall handled line dedicated p...
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384
Article 86
1. Any affected person subject to a decision which is taken by the deployer on the basis of the output from a high-risk AI system listed in Annex III, with the exception of systems listed under point 2 thereof, and which produces legal effects or similarly significantly affects that person in a way that they consider...
affected person subject decision taken deployer basis output high risk system listed annex iii exception system listed point thereof produce legal effect similarly significantly affect person way consider adverse impact health safety fundamental right shall right obtain deployer clear meaningful explanation role system...
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all-MiniLM-L6-v2
384
Article 87
Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.
directive 2019 1937 shall apply reporting infringement regulation protection person reporting infringement
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all-MiniLM-L6-v2
384
Article 88
1. The Commission shall have exclusive powers to supervise and enforce Chapter V, taking into account the procedural guarantees under Article 94. The Commission shall entrust the implementation of these tasks to the AI Office, without prejudice to the powers of organisation of the Commission and the division of compe...
commission shall exclusive power supervise enforce chapter taking account procedural guarantee article commission shall entrust implementation task office without prejudice power organisation commission division competence member state union based treaty without prejudice article market surveillance authority may reque...
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all-MiniLM-L6-v2
384
Article 89
1. For the purpose of carrying out the tasks assigned to it under this Section, the AI Office may take the necessary actions to monitor the effective implementation and compliance with this Regulation by providers of general-purpose AI models, including their adherence to approved codes of practice. 2. Downstream p...
purpose carrying task assigned section office may take necessary action monitor effective implementation compliance regulation provider general purpose model including adherence approved code practice downstream provider shall right lodge complaint alleging infringement regulation complaint shall duly reasoned indicate...
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all-MiniLM-L6-v2
384
Article 90
1. The scientific panel may provide a qualified alert to the AI Office where it has reason to suspect that: (a) a general-purpose AI model poses concrete identifiable risk at Union level; or (a) a general-purpose AI model poses concrete identifiable risk at Union level; or (b) a general-purpose AI model meets the con...
scientific panel may provide qualified alert office reason suspect general purpose model pose concrete identifiable risk union level general purpose model pose concrete identifiable risk union level general purpose model meet condition referred article general purpose model meet condition referred article upon qualifie...
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384
Article 91
1. The Commission may request the provider of the general-purpose AI model concerned to provide the documentation drawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the purpose of assessing compliance of the provider with this Regulation. 2. Before se...
commission may request provider general purpose model concerned provide documentation drawn provider accordance article additional information necessary purpose assessing compliance provider regulation sending request information office may initiate structured dialogue provider general purpose model upon duly substanti...
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384
Article 92
1. The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned: (a) to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant to Article 91 is insufficient; or (a) to assess compliance of the provider with obli...
office consulting board may conduct evaluation general purpose model concerned assess compliance provider obligation regulation information gathered pursuant article insufficient assess compliance provider obligation regulation information gathered pursuant article insufficient investigate systemic risk union level gen...
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all-MiniLM-L6-v2
384
Article 93
1. Where necessary and appropriate, the Commission may request providers to: (a) take appropriate measures to comply with the obligations set out in Articles 53 and 54; (a) take appropriate measures to comply with the obligations set out in Articles 53 and 54; (b) implement mitigation measures, where the evaluation c...
necessary appropriate commission may request provider take appropriate measure comply obligation set article take appropriate measure comply obligation set article implement mitigation measure evaluation carried accordance article given rise serious substantiated concern systemic risk union level implement mitigation m...
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all-MiniLM-L6-v2
384
Article 94
Article 18 of Regulation (EU) 2019/1020 shall applymutatis mutandisto the providers of the general-purpose AI model, without prejudice to more specific procedural rights provided for in this Regulation.
article regulation 2019 1020 shall applymutatis mutandisto provider general purpose model without prejudice specific procedural right provided regulation
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all-MiniLM-L6-v2
384
Article 72
1. Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the nature of the AI technologies and the risks of the high-risk AI system. 2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data which may be p...
provider shall establish document post market monitoring system manner proportionate nature technology risk high risk system post market monitoring system shall actively systematically collect document analyse relevant data may provided deployers may collected source performance high risk system throughout lifetime all...
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all-MiniLM-L6-v2
384
Article 73
1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred. 2. The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link between the ...
provider high risk system placed union market shall report serious incident market surveillance authority member state incident occurred report referred paragraph shall made immediately provider established causal link system serious incident reasonable likelihood link event later day provider applicable deployer becom...
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all-MiniLM-L6-v2
384
Article 74
1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective enforcement of this Regulation: (a) any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation; (...
regulation 2019 1020 shall apply system covered regulation purpose effective enforcement regulation reference economic operator regulation 2019 1020 shall understood including operator identified article regulation reference economic operator regulation 2019 1020 shall understood including operator identified article r...
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all-MiniLM-L6-v2
384
Article 75
1. Where an AI system is based on a general-purpose AI model, and the model and the system are developed by the same provider, the AI Office shall have powers to monitor and supervise compliance of that AI system with obligations under this Regulation. To carry out its monitoring and supervision tasks, the AI Office ...
system based general purpose model model system developed provider office shall power monitor supervise compliance system obligation regulation carry monitoring supervision task office shall power market surveillance authority provided section regulation 2019 1020 relevant market surveillance authority sufficient reaso...
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all-MiniLM-L6-v2
384
Article 76
1. Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in accordance with this Regulation. 2. Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory sandbox under Article 58, the market surveilla...
market surveillance authority shall competence power ensure testing real world condition accordance regulation testing real world condition conducted system supervised within regulatory sandbox article market surveillance authority shall verify compliance article part supervisory role regulatory sandbox authority may a...
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all-MiniLM-L6-v2
384
Article 77
1. National public authorities or bodies which supervise or enforce the respect of obligations under Union law protecting fundamental rights, including the right to non-discrimination, in relation to the use of high-risk AI systems referred to in Annex III shall have the power to request and access any documentation ...
national public authority body supervise enforce respect obligation union law protecting fundamental right including right non discrimination relation use high risk system referred annex iii shall power request access documentation created maintained regulation accessible language format access documentation necessary ...
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all-MiniLM-L6-v2
384
Article 78
1. The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a...
commission market surveillance authority notified body natural legal person involved application regulation shall accordance union national law respect confidentiality information data obtained carrying task activity manner protect particular intellectual property right confidential business information trade secret na...
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Article 79
1. AI systems presenting a risk shall be understood as a β€˜product presenting a risk’ as defined in Article 3, point 19 of Regulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights, of persons. 2. Where the market surveillance authority of a Member State has suffici...
system presenting risk shall understood product presenting risk defined article point regulation 2019 1020 far present risk health safety fundamental right person market surveillance authority member state sufficient reason consider system present risk referred paragraph article shall carry evaluation system concerned ...
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Article 80
1. Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of the AI system concerned in respect of its classification as a high-r...
market surveillance authority sufficient reason consider system classified provider non high risk pursuant article indeed high risk market surveillance authority shall carry evaluation system concerned respect classification high risk system based condition set article commission guideline course evaluation market surv...
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Article 81
1. Where, within three months of receipt of the notification referred to in Article 79(5), or within 30 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, objections are raised by the market surveillance authority of a Member State to a measure taken by another marke...
within three month receipt notification referred article within day case non compliance prohibition practice referred article objection raised market surveillance authority member state measure taken another market surveillance authority commission considers measure contrary union law commission shall without undue del...
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Article 82
1. Where, having performed an evaluation under Article 79, after consulting the relevant national public authority referred to in Article 77(1), the market surveillance authority of a Member State finds that although a high-risk AI system complies with this Regulation, it nevertheless presents a risk to the health or...
performed evaluation article consulting relevant national public authority referred article market surveillance authority member state find although high risk system complies regulation nevertheless present risk health safety person fundamental right aspect public interest protection shall require relevant operator tak...
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Article 83
1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant provider to put an end to the non-compliance concerned, within a period it may prescribe: (a) the CE marking has been affixed in violation of Article 48; (a) the CE marking has been affixed ...
market surveillance authority member state make one following finding shall require relevant provider put end non compliance concerned within period may prescribe marking affixed violation article marking affixed violation article marking affixed marking affixed declaration conformity referred article drawn declaration...
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Article 84
1. The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under Article 21(6) of Regulation (EU) 2019/1020 in the area of AI. 2. Without prejudice to the tasks referred to in paragraph 1, Union AI testing support structures shall also provide independent technical...
commission shall designate one union testing support structure perform task listed article regulation 2019 1020 area without prejudice task referred paragraph union testing support structure shall also provide independent technical scientific advice request board commission market surveillance authority
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384
Article 85
Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that there has been an infringement of the provisions of this Regulation may submit complaints to the relevant market surveillance authority. In accordance with Regulation (EU) 2019/1020, such complain...
without prejudice administrative judicial remedy natural legal person ground consider infringement provision regulation may submit complaint relevant market surveillance authority accordance regulation 2019 1020 complaint shall taken account purpose conducting market surveillance activity shall handled line dedicated p...
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Article 86
1. Any affected person subject to a decision which is taken by the deployer on the basis of the output from a high-risk AI system listed in Annex III, with the exception of systems listed under point 2 thereof, and which produces legal effects or similarly significantly affects that person in a way that they consider...
affected person subject decision taken deployer basis output high risk system listed annex iii exception system listed point thereof produce legal effect similarly significantly affect person way consider adverse impact health safety fundamental right shall right obtain deployer clear meaningful explanation role system...
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384
Article 87
Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements.
directive 2019 1937 shall apply reporting infringement regulation protection person reporting infringement
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384
Article 88
1. The Commission shall have exclusive powers to supervise and enforce Chapter V, taking into account the procedural guarantees under Article 94. The Commission shall entrust the implementation of these tasks to the AI Office, without prejudice to the powers of organisation of the Commission and the division of compe...
commission shall exclusive power supervise enforce chapter taking account procedural guarantee article commission shall entrust implementation task office without prejudice power organisation commission division competence member state union based treaty without prejudice article market surveillance authority may reque...
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384
Article 89
1. For the purpose of carrying out the tasks assigned to it under this Section, the AI Office may take the necessary actions to monitor the effective implementation and compliance with this Regulation by providers of general-purpose AI models, including their adherence to approved codes of practice. 2. Downstream p...
purpose carrying task assigned section office may take necessary action monitor effective implementation compliance regulation provider general purpose model including adherence approved code practice downstream provider shall right lodge complaint alleging infringement regulation complaint shall duly reasoned indicate...
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384
Article 90
1. The scientific panel may provide a qualified alert to the AI Office where it has reason to suspect that: (a) a general-purpose AI model poses concrete identifiable risk at Union level; or (a) a general-purpose AI model poses concrete identifiable risk at Union level; or (b) a general-purpose AI model meets the con...
scientific panel may provide qualified alert office reason suspect general purpose model pose concrete identifiable risk union level general purpose model pose concrete identifiable risk union level general purpose model meet condition referred article general purpose model meet condition referred article upon qualifie...
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384
Article 91
1. The Commission may request the provider of the general-purpose AI model concerned to provide the documentation drawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the purpose of assessing compliance of the provider with this Regulation. 2. Before se...
commission may request provider general purpose model concerned provide documentation drawn provider accordance article additional information necessary purpose assessing compliance provider regulation sending request information office may initiate structured dialogue provider general purpose model upon duly substanti...
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384
Article 92
1. The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned: (a) to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant to Article 91 is insufficient; or (a) to assess compliance of the provider with obli...
office consulting board may conduct evaluation general purpose model concerned assess compliance provider obligation regulation information gathered pursuant article insufficient assess compliance provider obligation regulation information gathered pursuant article insufficient investigate systemic risk union level gen...
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384
Article 93
1. Where necessary and appropriate, the Commission may request providers to: (a) take appropriate measures to comply with the obligations set out in Articles 53 and 54; (a) take appropriate measures to comply with the obligations set out in Articles 53 and 54; (b) implement mitigation measures, where the evaluation c...
necessary appropriate commission may request provider take appropriate measure comply obligation set article take appropriate measure comply obligation set article implement mitigation measure evaluation carried accordance article given rise serious substantiated concern systemic risk union level implement mitigation m...
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384
Article 94
Article 18 of Regulation (EU) 2019/1020 shall applymutatis mutandisto the providers of the general-purpose AI model, without prejudice to more specific procedural rights provided for in this Regulation.
article regulation 2019 1020 shall applymutatis mutandisto provider general purpose model without prejudice specific procedural right provided regulation
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384
Article 95
1. The AI Office and the Member States shall encourage and facilitate the drawing up of codes of conduct, including related governance mechanisms, intended to foster the voluntary application to AI systems, other than high-risk AI systems, of some or all of the requirements set out in Chapter III, Section 2 taking in...
office member state shall encourage facilitate drawing code conduct including related governance mechanism intended foster voluntary application system high risk system requirement set chapter iii section taking account available technical solution industry best practice allowing application requirement office member s...
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384
Article 96
1. The Commission shall develop guidelines on the practical implementation of this Regulation, and in particular on: (a) the application of the requirements and obligations referred to in Articles 8 to 15 and in Article 25; (a) the application of the requirements and obligations referred to in Articles 8 to 15 and in...
commission shall develop guideline practical implementation regulation particular application requirement obligation referred article article application requirement obligation referred article article prohibited practice referred article prohibited practice referred article practical implementation provision related s...
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384
Article 97
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 6(6) and (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article 52(4) and Article 53(5)...
power adopt delegated act conferred commission subject condition laid article power adopt delegated act referred article article article article article article article article shall conferred commission period five year august 2024 commission shall draw report respect delegation power later nine month end five year pe...
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384
Article 98
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
commission shall assisted committee committee shall committee within meaning regulation 182 2011 reference made paragraph article regulation 182 2011 shall apply
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384
Article 99
1. In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties and other enforcement measures, which may also include warnings and non-monetary measures, applicable to infringements of this Regulation by operators, and shall take all measures necessary...
accordance term condition laid regulation member state shall lay rule penalty enforcement measure may also include warning non monetary measure applicable infringement regulation operator shall take measure necessary ensure properly effectively implemented thereby taking account guideline issued commission pursuant art...
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384
Article 100
1. The European Data Protection Supervisor may impose administrative fines on Union institutions, bodies, offices and agencies falling within the scope of this Regulation. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all rel...
european data protection supervisor may impose administrative fine union institution body office agency falling within scope regulation deciding whether impose administrative fine deciding amount administrative fine individual case relevant circumstance specific situation shall taken account due regard shall given foll...
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384
Article 101
1. The Commission may impose on providers of general-purpose AI models fines not exceeding 3 % of their annual total worldwide turnover in the preceding financial year or EUR 15 000 000, whichever is higher., when the Commission finds that the provider intentionally or negligently: (a) infringed the relevant provisio...
commission may impose provider general purpose model fine exceeding annual total worldwide turnover preceding financial year eur 000 000 whichever higher commission find provider intentionally negligently infringed relevant provision regulation infringed relevant provision regulation failed comply request document info...
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384
Article 102
In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added: β€˜When adopting detailed measures related to technical specifications and procedures for approval and use of security equipment concerning Artificial Intelligence systems within the meaning of Regulation (EU) 2024/1689 of the European P...
article regulation 300 2008 following subparagraph added adopting detailed measure related technical specification procedure approval use security equipment concerning artificial intelligence system within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall take...
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all-MiniLM-L6-v2
384
Article 103
In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added: β€˜When adopting delegated acts pursuant to the first subparagraph concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), t...
article regulation 167 2013 following subparagraph added adopting delegated act pursuant first subparagraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account
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all-MiniLM-L6-v2
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Article 104
In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added: β€˜When adopting delegated acts pursuant to the first subparagraph concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), t...
article regulation 168 2013 following subparagraph added adopting delegated act pursuant first subparagraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account
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384
Article 105
In Article 8 of Directive 2014/90/EU, the following paragraph is added: β€˜5. For Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), when carrying out its activities pursuant to paragraph 1 and when adopting techni...
article directive 2014 following paragraph added artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council carrying activity pursuant paragraph adopting technical specification testing standard accordance paragraph commission shall take account requirement set chapt...
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all-MiniLM-L6-v2
384
Article 106
In Article 5 of Directive (EU) 2016/797, the following paragraph is added: β€˜12. When adopting delegated acts pursuant to paragraph 1 and implementing acts pursuant to paragraph 11 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Par...
article directive 2016 797 following paragraph added adopting delegated act pursuant paragraph implementing act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account
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all-MiniLM-L6-v2
384
Article 107
In Article 5 of Regulation (EU) 2018/858 the following paragraph is added: β€˜4. When adopting delegated acts pursuant to paragraph 3 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), the requirements s...
article regulation 2018 858 following paragraph added adopting delegated act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account
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384
Article 108
Regulation (EU) 2018/1139 is amended as follows: (1) in Article 17, the following paragraph is added: β€˜3. Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of ...
regulation 2018 1139 amended follows article following paragraph added without prejudice paragraph adopting implementing act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall ...
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Article 109
In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added: β€˜3. When adopting the implementing acts pursuant to paragraph 2, concerning artificial intelligence systems which are safety components within the meaning of Regulation (EU) 2024/1689 of the European Parliament and of the Council(), the req...
article regulation 2019 2144 following paragraph added adopting implementing act pursuant paragraph concerning artificial intelligence system safety component within meaning regulation 2024 1689 european parliament council requirement set chapter iii section regulation shall taken account
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Article 110
In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council(), the following point is added: β€˜(68) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 1...
annex directive 2020 1828 european parliament council following point added regulation 2024 1689 european parliament council june 2024 laying harmonised rule artificial intelligence amending regulation 300 2008 167 2013 168 2013 2018 858 2018 1139 2019 2144 directive 2014 2016 797 2020 1828 artificial intelligence act ...
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Article 111
1. Without prejudice to the application of Article 5 as referred to in Article 113(3), point (a), AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex X that have been placed on the market or put into service before 2 August 2027 shall be brought into compliance ...
without prejudice application article referred article 113 point system component large scale system established legal act listed annex placed market put service august 2027 shall brought compliance regulation december 2030 requirement laid regulation shall taken account evaluation large scale system established legal ...
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Article 112
1. The Commission shall assess the need for amendment of the list set out in Annex III and of the list of prohibited AI practices laid down in Article 5, once a year following the entry into force of this Regulation, and until the end of the period of the delegation of power laid down in Article 97. The Commission sh...
commission shall assess need amendment list set annex iii list prohibited practice laid article year following entry force regulation end period delegation power laid article commission shall submit finding assessment european parliament council august 2028 every four year thereafter commission shall evaluate report eu...
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Article 113
This Regulation shall enter into force on the twentieth day following that of its publication in theOfficial Journal of the European Union. It shall apply from 2 August 2026. However: (a) Chapters I and II shall apply from 2 February 2025; (a) Chapters I and II shall apply from 2 February 2025; (b) Chapter III Section ...
regulation shall enter force twentieth day following publication theofficial journal european union shall apply august 2026 however chapter shall apply february 2025 chapter shall apply february 2025 chapter iii section chapter chapter vii chapter xii article shall apply august 2025 exception article 101 chapter iii se...
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Annex I
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.
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Annex II
Criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii): β€” terrorism, β€” trafficking in human beings, β€” sexual exploitation of children, and child pornography, β€” illicit trafficking in narcotic drugs or psychotropic substances, β€” illicit trafficking in weapons, munitions or explosives, β€” murder...
criminal offence referred article first subparagraph point iii terrorism trafficking human being sexual exploitation child child pornography illicit trafficking narcotic drug psychotropic substance illicit trafficking weapon munition explosive murder grievous bodily injury illicit trade human organ tissue illicit traff...
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Annex III
High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas: 1. Biometrics, in so far as their use is permitted under relevant Union or national law: (a) remote biometric identification systems. This shall not include AI systems intended to be used for biometric verification th...
high risk system pursuant article system listed following area biometrics far use permitted relevant union national law remote biometric identification system shall include system intended used biometric verification sole purpose confirm specific natural person person claim system intended used biometric categorisation...
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Annex IV
The technical documentation referred to in Article 11(1) shall contain at least the following information, as applicable to the relevant AI system: 1. A general description of the AI system including: (a) its intended purpose, the name of the provider and the version of the system reflecting its relation to previous ve...
technical documentation referred article shall contain least following information applicable relevant system general description system including intended purpose name provider version system reflecting relation previous version system interacts used interact hardware software including system part system applicable v...
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Annex V
The EU declaration of conformity referred to in Article 47, shall contain all of the following information: 1. AI system name and type and any additional unambiguous reference allowing the identification and traceability of the AI system; 2. The name and address of the provider or, where applicable, of their authorised...
declaration conformity referred article shall contain following information system name type additional unambiguous reference allowing identification traceability system name address provider applicable authorised representative statement declaration conformity referred article issued sole responsibility provider state...
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Annex VII
Conformity based on an assessment of the quality management system and an assessment of the technical documentation is the conformity assessment procedure based on points 2 to 5. The approved quality management system for the design, development and testing of AI systems pursuant to Article 17 shall be examined in acco...
conformity based assessment quality management system assessment technical documentation conformity assessment procedure based point approved quality management system design development testing system pursuant article shall examined accordance point shall subject surveillance specified point technical documentation sy...
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