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Preamble (Recitals) | (1)
The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, the placing on the market, the putting into service and the use of artificial intelligence systems (AI systems) in the Union, in accordance with Union value... | purpose regulation improve functioning internal market laying uniform legal framework particular development placing market putting service use artificial intelligence system system union accordance union value promote uptake human centric trustworthy artificial intelligence ensuring high level protection health safety... | [
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Article 1 | 1. The purpose of this Regulation is to improve the functioning of the internal market and promote the uptake of human-centric and trustworthy artificial intelligence (AI), while ensuring a high level of protection of health, safety, fundamental rights enshrined in the Charter, including democracy, the rule of law an... | purpose regulation improve functioning internal market promote uptake human centric trustworthy artificial intelligence ensuring high level protection health safety fundamental right enshrined charter including democracy rule law environmental protection harmful effect system union supporting innovation regulation lay ... | [
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Article 2 | 1. This Regulation applies to:
(a) providers placing on the market or putting into service AI systems or placing on the market general-purpose AI models in the Union, irrespective of whether those providers are established or located within the Union or in a third country;
(a)
providers placing on the market or putti... | regulation applies provider placing market putting service system placing market general purpose model union irrespective whether provider established located within union third country provider placing market putting service system placing market general purpose model union irrespective whether provider established lo... | [
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Article 3 | For the purposes of this Regulation, the following definitions apply:
(1) ‘AI system’ means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to gen... | purpose regulation following definition apply system mean machine based system designed operate varying level autonomy may exhibit adaptiveness deployment explicit implicit objective infers input receives generate output prediction content recommendation decision influence physical virtual environment system mean machi... | [
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Article 4 | Providers and deployers of AI systems shall take measures to ensure, to their best extent, a sufficient level of AI literacy of their staff and other persons dealing with the operation and use of AI systems on their behalf, taking into account their technical knowledge, experience, education and training and the contex... | provider deployers system shall take measure ensure best extent sufficient level literacy staff person dealing operation use system behalf taking account technical knowledge experience education training context system used considering person group person system used | [
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Article 5 | 1. The following AI practices shall be prohibited:
(a) the placing on the market, the putting into service or the use of an AI system that deploys subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective, or the effect of materially distorting the ... | following practice shall prohibited placing market putting service use system deploys subliminal technique beyond person consciousness purposefully manipulative deceptive technique objective effect materially distorting behaviour person group person appreciably impairing ability make informed decision thereby causing t... | [
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Article 6 | 1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:
(a) the AI system is intended to be used as a safety component o... | irrespective whether system placed market put service independently product referred point system shall considered high risk following condition fulfilled system intended used safety component product system product covered union harmonisation legislation listed annex system intended used safety component product syste... | [
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Article 7 | 1. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:
(a) the AI systems are intended to be used in any of the areas listed in Annex III;
(a)
the AI systems ... | commission empowered adopt delegated act accordance article amend annex iii adding modifying use case high risk system following condition fulfilled system intended used area listed annex iii system intended used area listed annex iii system pose risk harm health safety adverse impact fundamental right risk equivalent ... | [
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Article 8 | 1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management system referred to in Article 9 shall be taken into account when ensuring compl... | high risk system shall comply requirement laid section taking account intended purpose well generally acknowledged state art related technology risk management system referred article shall taken account ensuring compliance requirement product contains system requirement regulation well requirement union harmonisation ... | [
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Article 9 | 1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.
2. The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic rev... | risk management system shall established implemented documented maintained relation high risk system risk management system shall understood continuous iterative process planned run throughout entire lifecycle high risk system requiring regular systematic review updating shall comprise following step identification ana... | [
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Article 10 | 1. High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5 whenever such data sets are used.
2. Training, validation and testing data ... | high risk system make use technique involving training model data shall developed basis training validation testing data set meet quality criterion referred paragraph whenever data set used training validation testing data set shall subject data governance management practice appropriate intended purpose high risk syst... | [
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Article 11 | 1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date.
The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in th... | technical documentation high risk system shall drawn system placed market put service shall kept date technical documentation shall drawn way demonstrate high risk system complies requirement set section provide national competent authority notified body necessary information clear comprehensive form assess compliance ... | [
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Article 12 | 1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system.
2. In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended purpose of the system, logging capabilities shall enable the rec... | high risk system shall technically allow automatic recording event log lifetime system order ensure level traceability functioning high risk system appropriate intended purpose system logging capability shall enable recording event relevant identifying situation may result high risk system presenting risk within meanin... | [
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Article 13 | 1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of transparency shall be ensured with a view to achieving compliance with the ... | high risk system shall designed developed way ensure operation sufficiently transparent enable deployers interpret system output use appropriately appropriate type degree transparency shall ensured view achieving compliance relevant obligation provider deployer set section high risk system shall accompanied instruction... | [
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Article 14 | 1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons during the period in which they are in use.
2. Human oversight shall aim to prevent or minimise the risks to health, safety or fun... | high risk system shall designed developed way including appropriate human machine interface tool effectively overseen natural person period use human oversight shall aim prevent minimise risk health safety fundamental right may emerge high risk system used accordance intended purpose condition reasonably foreseeable mi... | [
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Article 15 | 1. High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy, robustness, and cybersecurity, and that they perform consistently in those respects throughout their lifecycle.
2. To address the technical aspects of how to measure the appropriate levels of ac... | high risk system shall designed developed way achieve appropriate level accuracy robustness cybersecurity perform consistently respect throughout lifecycle address technical aspect measure appropriate level accuracy robustness set paragraph relevant performance metric commission shall cooperation relevant stakeholder o... | [
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Article 16 | Providers of high-risk AI systems shall:
(a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
(a)
ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
(b) indicate on the high-risk AI system or, where that is not possible, on it... | provider high risk system shall ensure high risk system compliant requirement set section ensure high risk system compliant requirement set section indicate high risk system possible packaging accompanying documentation applicable name registered trade name registered trade mark address contacted indicate high risk sys... | [
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Article 17 | 1. Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at least the following aspects:
(a) a str... | provider high risk system shall put quality management system place ensures compliance regulation system shall documented systematic orderly manner form written policy procedure instruction shall include least following aspect strategy regulatory compliance including compliance conformity assessment procedure procedure... | [
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Article 18 | 1. The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities:
(a) the technical documentation referred to in Article 11;
(a)
the technical documentation referred to in Article 11;
(b) the... | provider shall period ending year high risk system placed market put service keep disposal national competent authority technical documentation referred article technical documentation referred article documentation concerning quality management system referred article documentation concerning quality management system... | [
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Article 19 | 1. Providers of high-risk AI systems shall keep the logs referred to in Article 12(1), automatically generated by their high-risk AI systems, to the extent such logs are under their control. Without prejudice to applicable Union or national law, the logs shall be kept for a period appropriate to the intended purpose ... | provider high risk system shall keep log referred article automatically generated high risk system extent log control without prejudice applicable union national law log shall kept period appropriate intended purpose high risk system least six month unless provided otherwise applicable union national law particular uni... | [
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Article 20 | 1. Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective actions to bring that system into conformity, to withdraw it, to d... | provider high risk system consider reason consider high risk system placed market put service conformity regulation shall immediately take necessary corrective action bring system conformity withdraw disable recall appropriate shall inform distributor high risk system concerned applicable deployers authorised represent... | [
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Article 21 | 1. Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all the information and documentation necessary to demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2, in a language which can be easily understood by the ... | provider high risk system shall upon reasoned request competent authority provide authority information documentation necessary demonstrate conformity high risk system requirement set section language easily understood authority one official language institution union indicated member state concerned upon reasoned requ... | [
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Article 22 | 1. Prior to making their high-risk AI systems available 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 ma... | prior making high risk system available 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 mandat... | [
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Article 23 | 1. Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that:
(a) the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk AI system;
(a)
the relevant conformity... | placing high risk system market importer shall ensure system conformity regulation verifying relevant conformity assessment procedure referred article carried provider high risk system relevant conformity assessment procedure referred article carried provider high risk system provider drawn technical documentation acco... | [
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Article 24 | 1. Before making a high-risk AI system available on the market, distributors shall verify that it bears the required CE marking, that it is accompanied by a copy of the EU declaration of conformity referred to in Article 47 and instructions for use, and that the provider and the importer of that system, as applicable... | making high risk system available market distributor shall verify bear required marking accompanied copy declaration conformity referred article instruction use provider importer system applicable complied respective obligation laid article point article distributor considers reason consider basis information possessio... | [
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Article 25 | 1. Any distributor, importer, deployer or other third-party shall be considered to be a provider of a high-risk AI system for the purposes of this Regulation and shall be subject to the obligations of the provider under Article 16, in any of the following circumstances:
(a) they put their name or trademark on a high-... | distributor importer deployer third party shall considered provider high risk system purpose regulation shall subject obligation provider article following circumstance put name trademark high risk system already placed market put service without prejudice contractual arrangement stipulating obligation otherwise alloca... | [
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Article 26 | 1. Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use such systems in accordance with the instructions for use accompanying the systems, pursuant to paragraphs 3 and 6.
2. Deployers shall assign human oversight to natural persons who have the necessary ... | deployers high risk system shall take appropriate technical organisational measure ensure use system accordance instruction use accompanying system pursuant paragraph deployers shall assign human oversight natural person necessary competence training authority well necessary support obligation set paragraph without pre... | [
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Article 27 | 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... | prior deploying high risk system referred article exception high risk system intended used area listed point annex iii deployers body governed public law private entity providing public service deployers high risk system referred point annex iii shall perform assessment impact fundamental right use system may produce p... | [
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Article 28 | 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 ... | member state shall designate establish least one notifying authority responsible setting carrying necessary procedure assessment designation notification conformity assessment body monitoring procedure shall developed cooperation notifying authority member state member state may decide assessment monitoring referred pa... | [
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Article 29 | 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 an... | conformity assessment body shall submit application notification notifying authority member state established application notification shall accompanied description conformity assessment activity conformity assessment module module type system conformity assessment body claim competent well accreditation certificate on... | [
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Article 30 | 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 as... | notifying authority may notify conformity assessment body satisfied requirement laid article notifying authority shall notify commission member state using electronic notification tool developed managed commission conformity assessment body referred paragraph notification referred paragraph article shall include full d... | [
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Article 31 | 1. A notified body shall be established under the national law of a Member State and shall have legal personality.
2. Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks, as well as suitable cybersecurity requirements.
3. ... | notified body shall established national law member state shall legal personality notified body shall satisfy organisational quality management resource process requirement necessary fulfil task well suitable cybersecurity requirement organisational structure allocation responsibility reporting line operation notified ... | [
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Article 32 | 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 theOfficial Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 31 in so far... | conformity assessment body demonstrates conformity criterion laid relevant harmonised standard part thereof reference published theofficial journal european union shall presumed comply requirement set article far applicable harmonised standard cover requirement | [
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Article 33 | 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 ... | notified body subcontract specific task connected conformity assessment recourse subsidiary shall ensure subcontractor subsidiary meet requirement laid article shall inform notifying authority accordingly notified body shall take full responsibility task performed subcontractor subsidiary activity may subcontracted car... | [
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Article 34 | 1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43.
2. Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account of the size of the provider, the sector in whi... | notified body shall verify conformity high risk system accordance conformity assessment procedure set article notified body shall avoid unnecessary burden provider performing activity take due account size provider sector operates structure degree complexity high risk system concerned particular view minimising adminis... | [
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Article 35 | 1. The Commission shall assign a single identification number to each notified body, even where a body is notified under more than one Union act.
2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including their identification numbers and the activities for which... | commission shall assign single identification number notified body even body notified one union act commission shall make publicly available list body notified regulation including identification number activity notified commission shall ensure list kept date | [
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Article 36 | 1. The notifying authority shall notify the Commission and the other Member States of any relevant changes to the notification of a notified body via the electronic notification tool referred to in Article 30(2).
2. The procedures laid down in Articles 29 and 30 shall apply to extensions of the scope of the notific... | notifying authority shall notify commission member state relevant change notification notified body via electronic notification tool referred article procedure laid article shall apply extension scope notification change notification extension scope procedure laid paragraph shall apply notified body decides cease confo... | [
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Article 37 | 1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment by a notified body of the requirements laid down in Article 31 and of its applicable responsibilities.
2. The notifying authority shall provide the Commissio... | commission shall necessary investigate case reason doubt competence notified body continued fulfilment notified body requirement laid article applicable responsibility notifying authority shall provide commission request relevant information relating notification maintenance competence notified body concerned commissio... | [
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Article 38 | 1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation between notified bodies active in the conformity assessment procedures pursuant to this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies.
2. Each not... | commission shall ensure regard high risk system appropriate coordination cooperation notified body active conformity assessment procedure pursuant regulation put place properly operated form sectoral group notified body notifying authority shall ensure body notified participate work group referred paragraph directly de... | [
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Article 39 | Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified bodies under this Regulation, provided that they meet the requirements laid down in Article 31 or they ensure an equivalent level of complia... | conformity assessment body established law third country union concluded agreement may authorised carry activity notified body regulation provided meet requirement laid article ensure equivalent level compliance | [
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Article 40 | 1. High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts thereof the references of which have been published in theOfficial Journal of the European Unionin accordance with Regulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements se... | high risk system general purpose model conformity harmonised standard part thereof reference published theofficial journal european unionin accordance regulation 1025 2012 shall presumed conformity requirement set section chapter applicable obligation set chapter section regulation extent standard cover requirement obl... | [
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Article 41 | 1. The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V where the following conditions have been fulfilled:
(a) the Commission has requested, pursuant to ... | commission may adopt implementing act establishing common specification requirement set section chapter applicable obligation set section chapter following condition fulfilled commission requested pursuant article regulation 1025 2012 one european standardisation organisation draft harmonised standard requirement set s... | [
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Article 42 | 1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which they are intended to be used shall be presumed to comply with the relevant requirements laid down in Article 10(4).
2. High-risk AI systems that have bee... | high risk system trained tested data reflecting specific geographical behavioural contextual functional setting within intended used shall presumed comply relevant requirement laid article high risk system certified statement conformity issued cybersecurity scheme pursuant regulation 2019 881 reference published theoff... | [
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Article 43 | 1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the pr... | high risk system listed point annex iii demonstrating compliance high risk system requirement set section provider applied harmonised standard referred article applicable common specification referred article provider shall opt one following conformity assessment procedure based internal control referred annex internal... | [
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Article 44 | 1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a language which can be easily understood by the relevant authorities in the Member State in which the notified body is established.
2. Certificates shall be valid for the period they indicate, which shall not exceed five ye... | certificate issued notified body accordance annex vii shall drawn language easily understood relevant authority member state notified body established certificate shall valid period indicate shall exceed five year system covered annex four year system covered annex iii request provider validity certificate may extended... | [
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Article 45 | 1. Notified bodies shall inform the notifying authority of the following:
(a) any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;
(a)
any Union technical documentation ass... | notified body shall inform notifying authority following union technical documentation assessment certificate supplement certificate quality management system approval issued accordance requirement annex vii union technical documentation assessment certificate supplement certificate quality management system approval i... | [
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Article 46 | 1. By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security or the protec... | way derogation article upon duly justified request market surveillance authority may authorise placing market putting service specific high risk system within territory member state concerned exceptional reason public security protection life health person environmental protection protection key industrial infrastructu... | [
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Article 47 | 1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI system, and keep it at the disposal of the national competent authorities for 10 years after the high-risk AI system has been placed on the market or put into service. The EU ... | provider shall draw written machine readable physical electronically signed declaration conformity high risk system keep disposal national competent authority year high risk system placed market put service declaration conformity shall identify high risk system drawn copy declaration conformity shall submitted relevant... | [
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Article 48 | 1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
2. For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it can easily be accessed via the interface from which that system is accessed or via an easily accessible ma... | marking shall subject general principle set article regulation 765 2008 high risk system provided digitally digital marking shall used easily accessed via interface system accessed via easily accessible machine readable code electronic mean marking shall affixed visibly legibly indelibly high risk system possible warra... | [
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Article 49 | 1. Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of high-risk AI systems referred to in point 2 of Annex III, the provider or, where applicable, the authorised representative shall register themselves and their system in the EU database referred to ... | placing market putting service high risk system listed annex iii exception high risk system referred point annex iii provider applicable authorised representative shall register system database referred article placing market putting service system provider concluded high risk according article provider applicable auth... | [
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Article 6 | 1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:
(a) the AI system is intended to be used as a safety component o... | irrespective whether system placed market put service independently product referred point system shall considered high risk following condition fulfilled system intended used safety component product system product covered union harmonisation legislation listed annex system intended used safety component product syste... | [
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Article 7 | 1. The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:
(a) the AI systems are intended to be used in any of the areas listed in Annex III;
(a)
the AI systems ... | commission empowered adopt delegated act accordance article amend annex iii adding modifying use case high risk system following condition fulfilled system intended used area listed annex iii system intended used area listed annex iii system pose risk harm health safety adverse impact fundamental right risk equivalent ... | [
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Article 8 | 1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management system referred to in Article 9 shall be taken into account when ensuring compl... | high risk system shall comply requirement laid section taking account intended purpose well generally acknowledged state art related technology risk management system referred article shall taken account ensuring compliance requirement product contains system requirement regulation well requirement union harmonisation ... | [
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Article 9 | 1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.
2. The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic rev... | risk management system shall established implemented documented maintained relation high risk system risk management system shall understood continuous iterative process planned run throughout entire lifecycle high risk system requiring regular systematic review updating shall comprise following step identification ana... | [
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Article 10 | 1. High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5 whenever such data sets are used.
2. Training, validation and testing data ... | high risk system make use technique involving training model data shall developed basis training validation testing data set meet quality criterion referred paragraph whenever data set used training validation testing data set shall subject data governance management practice appropriate intended purpose high risk syst... | [
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Article 11 | 1. The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date.
The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in th... | technical documentation high risk system shall drawn system placed market put service shall kept date technical documentation shall drawn way demonstrate high risk system complies requirement set section provide national competent authority notified body necessary information clear comprehensive form assess compliance ... | [
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Article 12 | 1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system.
2. In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended purpose of the system, logging capabilities shall enable the rec... | high risk system shall technically allow automatic recording event log lifetime system order ensure level traceability functioning high risk system appropriate intended purpose system logging capability shall enable recording event relevant identifying situation may result high risk system presenting risk within meanin... | [
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Article 13 | 1. High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of transparency shall be ensured with a view to achieving compliance with the ... | high risk system shall designed developed way ensure operation sufficiently transparent enable deployers interpret system output use appropriately appropriate type degree transparency shall ensured view achieving compliance relevant obligation provider deployer set section high risk system shall accompanied instruction... | [
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Article 14 | 1. High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons during the period in which they are in use.
2. Human oversight shall aim to prevent or minimise the risks to health, safety or fun... | high risk system shall designed developed way including appropriate human machine interface tool effectively overseen natural person period use human oversight shall aim prevent minimise risk health safety fundamental right may emerge high risk system used accordance intended purpose condition reasonably foreseeable mi... | [
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Article 15 | 1. High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy, robustness, and cybersecurity, and that they perform consistently in those respects throughout their lifecycle.
2. To address the technical aspects of how to measure the appropriate levels of ac... | high risk system shall designed developed way achieve appropriate level accuracy robustness cybersecurity perform consistently respect throughout lifecycle address technical aspect measure appropriate level accuracy robustness set paragraph relevant performance metric commission shall cooperation relevant stakeholder o... | [
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Article 16 | Providers of high-risk AI systems shall:
(a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
(a)
ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
(b) indicate on the high-risk AI system or, where that is not possible, on it... | provider high risk system shall ensure high risk system compliant requirement set section ensure high risk system compliant requirement set section indicate high risk system possible packaging accompanying documentation applicable name registered trade name registered trade mark address contacted indicate high risk sys... | [
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Article 17 | 1. Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at least the following aspects:
(a) a str... | provider high risk system shall put quality management system place ensures compliance regulation system shall documented systematic orderly manner form written policy procedure instruction shall include least following aspect strategy regulatory compliance including compliance conformity assessment procedure procedure... | [
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Article 18 | 1. The provider shall, for a period ending 10 years after the high-risk AI system has been placed on the market or put into service, keep at the disposal of the national competent authorities:
(a) the technical documentation referred to in Article 11;
(a)
the technical documentation referred to in Article 11;
(b) the... | provider shall period ending year high risk system placed market put service keep disposal national competent authority technical documentation referred article technical documentation referred article documentation concerning quality management system referred article documentation concerning quality management system... | [
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Article 19 | 1. Providers of high-risk AI systems shall keep the logs referred to in Article 12(1), automatically generated by their high-risk AI systems, to the extent such logs are under their control. Without prejudice to applicable Union or national law, the logs shall be kept for a period appropriate to the intended purpose ... | provider high risk system shall keep log referred article automatically generated high risk system extent log control without prejudice applicable union national law log shall kept period appropriate intended purpose high risk system least six month unless provided otherwise applicable union national law particular uni... | [
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Article 20 | 1. Providers of high-risk AI systems which consider or have reason to consider that a high-risk AI system that they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective actions to bring that system into conformity, to withdraw it, to d... | provider high risk system consider reason consider high risk system placed market put service conformity regulation shall immediately take necessary corrective action bring system conformity withdraw disable recall appropriate shall inform distributor high risk system concerned applicable deployers authorised represent... | [
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Article 21 | 1. Providers of high-risk AI systems shall, upon a reasoned request by a competent authority, provide that authority all the information and documentation necessary to demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2, in a language which can be easily understood by the ... | provider high risk system shall upon reasoned request competent authority provide authority information documentation necessary demonstrate conformity high risk system requirement set section language easily understood authority one official language institution union indicated member state concerned upon reasoned requ... | [
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Article 22 | 1. Prior to making their high-risk AI systems available 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 ma... | prior making high risk system available 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 mandat... | [
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Article 23 | 1. Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that:
(a) the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk AI system;
(a)
the relevant conformity... | placing high risk system market importer shall ensure system conformity regulation verifying relevant conformity assessment procedure referred article carried provider high risk system relevant conformity assessment procedure referred article carried provider high risk system provider drawn technical documentation acco... | [
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Article 24 | 1. Before making a high-risk AI system available on the market, distributors shall verify that it bears the required CE marking, that it is accompanied by a copy of the EU declaration of conformity referred to in Article 47 and instructions for use, and that the provider and the importer of that system, as applicable... | making high risk system available market distributor shall verify bear required marking accompanied copy declaration conformity referred article instruction use provider importer system applicable complied respective obligation laid article point article distributor considers reason consider basis information possessio... | [
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Article 25 | 1. Any distributor, importer, deployer or other third-party shall be considered to be a provider of a high-risk AI system for the purposes of this Regulation and shall be subject to the obligations of the provider under Article 16, in any of the following circumstances:
(a) they put their name or trademark on a high-... | distributor importer deployer third party shall considered provider high risk system purpose regulation shall subject obligation provider article following circumstance put name trademark high risk system already placed market put service without prejudice contractual arrangement stipulating obligation otherwise alloca... | [
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Article 26 | 1. Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use such systems in accordance with the instructions for use accompanying the systems, pursuant to paragraphs 3 and 6.
2. Deployers shall assign human oversight to natural persons who have the necessary ... | deployers high risk system shall take appropriate technical organisational measure ensure use system accordance instruction use accompanying system pursuant paragraph deployers shall assign human oversight natural person necessary competence training authority well necessary support obligation set paragraph without pre... | [
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Article 27 | 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... | prior deploying high risk system referred article exception high risk system intended used area listed point annex iii deployers body governed public law private entity providing public service deployers high risk system referred point annex iii shall perform assessment impact fundamental right use system may produce p... | [
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Article 28 | 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 ... | member state shall designate establish least one notifying authority responsible setting carrying necessary procedure assessment designation notification conformity assessment body monitoring procedure shall developed cooperation notifying authority member state member state may decide assessment monitoring referred pa... | [
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Article 29 | 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 an... | conformity assessment body shall submit application notification notifying authority member state established application notification shall accompanied description conformity assessment activity conformity assessment module module type system conformity assessment body claim competent well accreditation certificate on... | [
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Article 30 | 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 as... | notifying authority may notify conformity assessment body satisfied requirement laid article notifying authority shall notify commission member state using electronic notification tool developed managed commission conformity assessment body referred paragraph notification referred paragraph article shall include full d... | [
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Article 31 | 1. A notified body shall be established under the national law of a Member State and shall have legal personality.
2. Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks, as well as suitable cybersecurity requirements.
3. ... | notified body shall established national law member state shall legal personality notified body shall satisfy organisational quality management resource process requirement necessary fulfil task well suitable cybersecurity requirement organisational structure allocation responsibility reporting line operation notified ... | [
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Article 32 | 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 theOfficial Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 31 in so far... | conformity assessment body demonstrates conformity criterion laid relevant harmonised standard part thereof reference published theofficial journal european union shall presumed comply requirement set article far applicable harmonised standard cover requirement | [
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Article 33 | 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 ... | notified body subcontract specific task connected conformity assessment recourse subsidiary shall ensure subcontractor subsidiary meet requirement laid article shall inform notifying authority accordingly notified body shall take full responsibility task performed subcontractor subsidiary activity may subcontracted car... | [
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Article 34 | 1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43.
2. Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account of the size of the provider, the sector in whi... | notified body shall verify conformity high risk system accordance conformity assessment procedure set article notified body shall avoid unnecessary burden provider performing activity take due account size provider sector operates structure degree complexity high risk system concerned particular view minimising adminis... | [
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Article 35 | 1. The Commission shall assign a single identification number to each notified body, even where a body is notified under more than one Union act.
2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including their identification numbers and the activities for which... | commission shall assign single identification number notified body even body notified one union act commission shall make publicly available list body notified regulation including identification number activity notified commission shall ensure list kept date | [
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Article 36 | 1. The notifying authority shall notify the Commission and the other Member States of any relevant changes to the notification of a notified body via the electronic notification tool referred to in Article 30(2).
2. The procedures laid down in Articles 29 and 30 shall apply to extensions of the scope of the notific... | notifying authority shall notify commission member state relevant change notification notified body via electronic notification tool referred article procedure laid article shall apply extension scope notification change notification extension scope procedure laid paragraph shall apply notified body decides cease confo... | [
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0... | all-MiniLM-L6-v2 | 384 |
Article 37 | 1. The Commission shall, where necessary, investigate all cases where there are reasons to doubt the competence of a notified body or the continued fulfilment by a notified body of the requirements laid down in Article 31 and of its applicable responsibilities.
2. The notifying authority shall provide the Commissio... | commission shall necessary investigate case reason doubt competence notified body continued fulfilment notified body requirement laid article applicable responsibility notifying authority shall provide commission request relevant information relating notification maintenance competence notified body concerned commissio... | [
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Article 38 | 1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation between notified bodies active in the conformity assessment procedures pursuant to this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies.
2. Each not... | commission shall ensure regard high risk system appropriate coordination cooperation notified body active conformity assessment procedure pursuant regulation put place properly operated form sectoral group notified body notifying authority shall ensure body notified participate work group referred paragraph directly de... | [
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Article 39 | Conformity assessment bodies established under the law of a third country with which the Union has concluded an agreement may be authorised to carry out the activities of notified bodies under this Regulation, provided that they meet the requirements laid down in Article 31 or they ensure an equivalent level of complia... | conformity assessment body established law third country union concluded agreement may authorised carry activity notified body regulation provided meet requirement laid article ensure equivalent level compliance | [
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Article 40 | 1. High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts thereof the references of which have been published in theOfficial Journal of the European Unionin accordance with Regulation (EU) No 1025/2012 shall be presumed to be in conformity with the requirements se... | high risk system general purpose model conformity harmonised standard part thereof reference published theofficial journal european unionin accordance regulation 1025 2012 shall presumed conformity requirement set section chapter applicable obligation set chapter section regulation extent standard cover requirement obl... | [
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Article 41 | 1. The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V where the following conditions have been fulfilled:
(a) the Commission has requested, pursuant to ... | commission may adopt implementing act establishing common specification requirement set section chapter applicable obligation set section chapter following condition fulfilled commission requested pursuant article regulation 1025 2012 one european standardisation organisation draft harmonised standard requirement set s... | [
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Article 42 | 1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which they are intended to be used shall be presumed to comply with the relevant requirements laid down in Article 10(4).
2. High-risk AI systems that have bee... | high risk system trained tested data reflecting specific geographical behavioural contextual functional setting within intended used shall presumed comply relevant requirement laid article high risk system certified statement conformity issued cybersecurity scheme pursuant regulation 2019 881 reference published theoff... | [
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Article 43 | 1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the pr... | high risk system listed point annex iii demonstrating compliance high risk system requirement set section provider applied harmonised standard referred article applicable common specification referred article provider shall opt one following conformity assessment procedure based internal control referred annex internal... | [
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Article 44 | 1. Certificates issued by notified bodies in accordance with Annex VII shall be drawn-up in a language which can be easily understood by the relevant authorities in the Member State in which the notified body is established.
2. Certificates shall be valid for the period they indicate, which shall not exceed five ye... | certificate issued notified body accordance annex vii shall drawn language easily understood relevant authority member state notified body established certificate shall valid period indicate shall exceed five year system covered annex four year system covered annex iii request provider validity certificate may extended... | [
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... | all-MiniLM-L6-v2 | 384 |
Article 45 | 1. Notified bodies shall inform the notifying authority of the following:
(a) any Union technical documentation assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;
(a)
any Union technical documentation ass... | notified body shall inform notifying authority following union technical documentation assessment certificate supplement certificate quality management system approval issued accordance requirement annex vii union technical documentation assessment certificate supplement certificate quality management system approval i... | [
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Article 46 | 1. By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security or the protec... | way derogation article upon duly justified request market surveillance authority may authorise placing market putting service specific high risk system within territory member state concerned exceptional reason public security protection life health person environmental protection protection key industrial infrastructu... | [
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Article 47 | 1. The provider shall draw up a written machine readable, physical or electronically signed EU declaration of conformity for each high-risk AI system, and keep it at the disposal of the national competent authorities for 10 years after the high-risk AI system has been placed on the market or put into service. The EU ... | provider shall draw written machine readable physical electronically signed declaration conformity high risk system keep disposal national competent authority year high risk system placed market put service declaration conformity shall identify high risk system drawn copy declaration conformity shall submitted relevant... | [
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Article 48 | 1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
2. For high-risk AI systems provided digitally, a digital CE marking shall be used, only if it can easily be accessed via the interface from which that system is accessed or via an easily accessible ma... | marking shall subject general principle set article regulation 765 2008 high risk system provided digitally digital marking shall used easily accessed via interface system accessed via easily accessible machine readable code electronic mean marking shall affixed visibly legibly indelibly high risk system possible warra... | [
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0.0... | all-MiniLM-L6-v2 | 384 |
Article 49 | 1. Before placing on the market or putting into service a high-risk AI system listed in Annex III, with the exception of high-risk AI systems referred to in point 2 of Annex III, the provider or, where applicable, the authorised representative shall register themselves and their system in the EU database referred to ... | placing market putting service high risk system listed annex iii exception high risk system referred point annex iii provider applicable authorised representative shall register system database referred article placing market putting service system provider concluded high risk according article provider applicable auth... | [
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Article 50 | 1. Providers shall ensure that AI systems intended to interact directly with natural persons are designed and developed in such a way that the natural persons concerned are informed that they are interacting with an AI system, unless this is obvious from the point of view of a natural person who is reasonably well-in... | provider shall ensure system intended interact directly natural person designed developed way natural person concerned informed interacting system unless obvious point view natural person reasonably well informed observant circumspect taking account circumstance context use obligation shall apply system authorised law ... | [
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0.01167... | 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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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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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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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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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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0.026... | all-MiniLM-L6-v2 | 384 |
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