hoololi/AI_Act_with_embeddings huggingface dataset:
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 and environmental protection, against the harmful effects of AI systems in the Union and supporting innovation.
2.   This Regulation lays down:
(a) harmonised rules for the placing on the market, the putting into service, and the use of AI systems in the Union;
(a)
harmonised rules for the placing on the market, the putting into service, and the use of AI systems in the Union;
(b) prohibitions of certain AI practices;
(b)
prohibitions of certain AI practices;
(c) specific requirements for high-risk AI systems and obligations for operators of such systems;
(c)
specific requirements for high-risk AI systems and obligations for operators of such systems;
(d) harmonised transparency rules for certain AI systems;
(d)
harmonised transparency rules for certain AI systems;
(e) harmonised rules for the placing on the market of general-purpose AI models;
(e)
harmonised rules for the placing on the market of general-purpose AI models;
(f) rules on market monitoring, market surveillance, governance and enforcement;
(f)
rules on market monitoring, market surveillance, governance and enforcement;
(g) measures to support innovation, with a particular focus on SMEs, including start-ups.
(g)
measures to support innovation, with a particular focus on SMEs, including start-ups.
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 context the AI systems are to be used in, and considering the persons or groups of persons on whom the AI systems are to be used.
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 compliance with those requirements.
2.   Where a product contains an AI system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Section A of Annex I apply, providers shall be responsible for ensuring that their product is fully compliant with all applicable requirements under applicable Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order to ensure consistency, avoid duplication and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist and are required under the Union harmonisation legislation listed in Section A of Annex I.
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 this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups, may provide the elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall establish a simplified technical documentation form targeted at the needs of small and microenterprises. Where an SME, including a start-up, opts to provide the information required in Annex IV in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.
2.   Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section A of Annex I is placed on the market or put into service, a single set of technical documentation shall be drawn up containing all the information set out in paragraph 1, as well as the information required under those legal acts.
3.   The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this Section.
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 recording of events relevant for:
(a) identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or in a substantial modification;
(a)
identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or in a substantial modification;
(b) facilitating the post-market monitoring referred to in Article 72; and
(b)
facilitating the post-market monitoring referred to in Article 72; and
(c) monitoring the operation of high-risk AI systems referred to in Article 26(5).
(c)
monitoring the operation of high-risk AI systems referred to in Article 26(5).
3.   For high-risk AI systems referred to in point 1 (a), of Annex III, the logging capabilities shall provide, at a minimum:
(a) recording of the period of each use of the system (start date and time and end date and time of each use);
(a)
recording of the period of each use of the system (start date and time and end date and time of each use);
(b) the reference database against which input data has been checked by the system;
(b)
the reference database against which input data has been checked by the system;
(c) the input data for which the search has led to a match;
(c)
the input data for which the search has led to a match;
(d) the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).
(d)
the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).
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 accuracy and robustness set out in paragraph 1 and any other relevant performance metrics, the Commission shall, in cooperation with relevant stakeholders and organisations such as metrology and benchmarking authorities, encourage, as appropriate, the development of benchmarks and measurement methodologies.
3.   The levels of accuracy and the relevant accuracy metrics of high-risk AI systems shall be declared in the accompanying instructions of use.
4.   High-risk AI systems shall be as resilient as possible regarding errors, faults or inconsistencies that may occur within the system or the environment in which the system operates, in particular due to their interaction with natural persons or other systems. Technical and organisational measures shall be taken in this regard.
The robustness of high-risk AI systems may be achieved through technical redundancy solutions, which may include backup or fail-safe plans.
High-risk AI systems that continue to learn after being placed on the market or put into service shall be developed in such a way as to eliminate or reduce as far as possible the risk of possibly biased outputs influencing input for future operations (feedback loops), and as to ensure that any such feedback loops are duly addressed with appropriate mitigation measures.
5.   High-risk AI systems shall be resilient against attempts by unauthorised third parties to alter their use, outputs or performance by exploiting system vulnerabilities.
The technical solutions aiming to ensure the cybersecurity of high-risk AI systems shall be appropriate to the relevant circumstances and the risks.
The technical solutions to address AI specific vulnerabilities shall include, where appropriate, measures to prevent, detect, respond to, resolve and control for attacks trying to manipulate the training data set (data poisoning), or pre-trained components used in training (model poisoning), inputs designed to cause the AI model to make a mistake (adversarial examples or model evasion), confidentiality attacks or model flaws.
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 its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;
(b)
indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;
(c) have a quality management system in place which complies with Article 17;
(c)
have a quality management system in place which complies with Article 17;
(d) keep the documentation referred to in Article 18;
(d)
keep the documentation referred to in Article 18;
(e) when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
(e)
when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
(f) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;
(f)
ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;
(g) draw up an EU declaration of conformity in accordance with Article 47;
(g)
draw up an EU declaration of conformity in accordance with Article 47;
(h) affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;
(h)
affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;
(i) comply with the registration obligations referred to in Article 49(1);
(i)
comply with the registration obligations referred to in Article 49(1);
(j) take the necessary corrective actions and provide information as required in Article 20;
(j)
take the necessary corrective actions and provide information as required in Article 20;
(k) upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;
(k)
upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;
(l) ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.
(l)
ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.
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 documentation concerning the quality management system referred to in Article 17;
(b)
the documentation concerning the quality management system referred to in Article 17;
(c) the documentation concerning the changes approved by notified bodies, where applicable;
(c)
the documentation concerning the changes approved by notified bodies, where applicable;
(d) the decisions and other documents issued by the notified bodies, where applicable;
(d)
the decisions and other documents issued by the notified bodies, where applicable;
(e) the EU declaration of conformity referred to in Article 47.
(e)
the EU declaration of conformity referred to in Article 47.
2.   Each Member State shall determine conditions under which the documentation referred to in paragraph 1 remains at the disposal of the national competent authorities for the period indicated in that paragraph for the cases when a provider or its authorised representative established on its territory goes bankrupt or ceases its activity prior to the end of that period.
3.   Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the technical documentation as part of the documentation kept under the relevant Union financial services law.
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 of the high-risk AI system, of at least six months, unless provided otherwise in the applicable Union or national law, in particular in Union law on the protection of personal data.
2.   Providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the logs automatically generated by their high-risk AI systems as part of the documentation kept under the relevant financial services law.
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 disable it, or to recall it, as appropriate. They shall inform the distributors of the high-risk AI system concerned and, where applicable, the deployers, the authorised representative and importers accordingly.
2.   Where the high-risk AI system presents a risk within the meaning of Article 79(1) and the provider becomes aware of that risk, it shall immediately investigate the causes, in collaboration with the reporting deployer, where applicable, and inform the market surveillance authorities competent for the high-risk AI system concerned and, where applicable, the notified body that issued a certificate for that high-risk AI system in accordance with Article 44, in particular, of the nature of the non-compliance and of any relevant corrective action taken.
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 authority in one of the official languages of the institutions of the Union as indicated by the Member State concerned.
2.   Upon a reasoned request by a competent authority, providers shall also give the requesting competent authority, as applicable, access to the automatically generated logs of the high-risk AI system referred to in Article 12(1), to the extent such logs are under their control.
3.   Any information obtained by a competent authority pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.
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 assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk AI system;
(b) the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;
(b)
the provider has drawn up the technical documentation in accordance with Article 11 and Annex IV;
(c) the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in Article 47 and instructions for use;
(c)
the system bears the required CE marking and is accompanied by the EU declaration of conformity referred to in Article 47 and instructions for use;
(d) the provider has appointed an authorised representative in accordance with Article 22(1).
(d)
the provider has appointed an authorised representative in accordance with Article 22(1).
2.   Where an importer has sufficient reason to consider that a high-risk AI system is not in conformity with this Regulation, or is falsified, or accompanied by falsified documentation, it shall not place the system on the market until it has been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the importer shall inform the provider of the system, the authorised representative and the market surveillance authorities to that effect.
3.   Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can be contacted on the high-risk AI system and on its packaging or its accompanying documentation, where applicable.
4.   Importers shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise its compliance with the requirements set out in Section 2.
5.   Importers shall keep, for a period of 10 years after the high-risk AI system has been placed on the market or put into service, a copy of the certificate issued by the notified body, where applicable, of the instructions for use, and of the EU declaration of conformity referred to in Article 47.
6.   Importers shall provide the relevant competent authorities, upon a reasoned request, with all the necessary information and documentation, including that referred to in paragraph 5, to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2 in a language which can be easily understood by them. For this purpose, they shall also ensure that the technical documentation can be made available to those authorities.
7.   Importers shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system placed on the market by the importers, in particular to reduce and mitigate the risks posed by it.
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, have complied with their respective obligations as laid down in Article 16, points (b) and (c) and Article 23(3).
2.   Where a distributor considers or has reason to consider, on the basis of the information in its possession, that a high-risk AI system is not in conformity with the requirements set out in Section 2, it shall not make the high-risk AI system available on the market until the system has been brought into conformity with those requirements. Furthermore, where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall inform the provider or the importer of the system, as applicable, to that effect.
3.   Distributors shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise the compliance of the system with the requirements set out in Section 2.
4.   A distributor that considers or has reason to consider, on the basis of the information in its possession, a high-risk AI system which it has made available on the market not to be in conformity with the requirements set out in Section 2, shall take the corrective actions necessary to bring that system into conformity with those requirements, to withdraw it or recall it, or shall ensure that the provider, the importer or any relevant operator, as appropriate, takes those corrective actions. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the distributor shall immediately inform the provider or importer of the system and the authorities competent for the high-risk AI system concerned, giving details, in particular, of the non-compliance and of any corrective actions taken.
5.   Upon a reasoned request from a relevant competent authority, distributors of a high-risk AI system shall provide that authority with all the information and documentation regarding their actions pursuant to paragraphs 1 to 4 necessary to demonstrate the conformity of that system with the requirements set out in Section 2.
6.   Distributors shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system made available on the market by the distributors, in particular to reduce or mitigate the risk posed by it.
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 the notifying authorities of all Member States.
2.   Member States may decide that the assessment and monitoring referred to in paragraph 1 is to be carried out by a national accreditation body within the meaning of, and in accordance with, Regulation (EC) No 765/2008.
3.   Notifying authorities shall be established, organised and operated in such a way that no conflict of interest arises with conformity assessment bodies, and that the objectivity and impartiality of their activities are safeguarded.
4.   Notifying authorities shall be organised in such a way that decisions relating to the notification of conformity assessment bodies are taken by competent persons different from those who carried out the assessment of those bodies.
5.   Notifying authorities shall offer or provide neither any activities that conformity assessment bodies perform, nor any consultancy services on a commercial or competitive basis.
6.   Notifying authorities shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
7.   Notifying authorities shall have an adequate number of competent personnel at their disposal for the proper performance of their tasks. Competent personnel shall have the necessary expertise, where applicable, for their function, in fields such as information technologies, AI and law, including the supervision of fundamental rights.
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 and the types of AI systems for which the conformity assessment body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 31.
Any valid document related to existing designations of the applicant notified body under any other Union harmonisation legislation shall be added.
3.   Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 31.
4.   For notified bodies which are designated under any other Union harmonisation legislation, all documents and certificates linked to those designations may be used to support their designation procedure under this Regulation, as appropriate. The notified body shall update the documentation referred to in paragraphs 2 and 3 of this Article whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements laid down in Article 31.
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 assessment body referred to in paragraph 1.
3.   The notification referred to in paragraph 2 of this Article shall include full details of the conformity assessment activities, the conformity assessment module or modules, the types of AI systems concerned, and the relevant attestation of competence. Where a notification is not based on an accreditation certificate as referred to in Article 29(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the competence of the conformity assessment body and to the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 31.
4.   The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification by a notifying authority where it includes an accreditation certificate referred to in Article 29(2), or within two months of a notification by the notifying authority where it includes documentary evidence referred to in Article 29(3).
5.   Where objections are raised, the Commission shall, without delay, enter into consultations with the relevant Member States and the conformity assessment body. In view thereof, the Commission shall decide whether the authorisation is justified. The Commission shall address its decision to the Member State concerned and to the relevant conformity assessment body.
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 as the applicable harmonised standards cover those requirements.
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 full responsibility for the tasks performed by any subcontractors or subsidiaries.
3.   Activities may be subcontracted or carried out by a subsidiary only with the agreement of the provider. Notified bodies shall make a list of their subsidiaries publicly available.
4.   The relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation shall be kept at the disposal of the notifying authority for a period of five years from the termination date of the subcontracting.
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 which it operates, its structure and the degree of complexity of the high-risk AI system concerned, in particular in view of minimising administrative burdens and compliance costs for micro- and small enterprises within the meaning of Recommendation 2003/361/EC. The notified body shall, nevertheless, respect the degree of rigour and the level of protection required for the compliance of the high-risk AI system with the requirements of this Regulation.
3.   Notified bodies shall make available and submit upon request all relevant documentation, including the providers’ documentation, to the notifying authority referred to in Article 28 to allow that authority to conduct its assessment, designation, notification and monitoring activities, and to facilitate the assessment outlined in this Section.
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 they have been notified. The Commission shall ensure that the list is kept up to date.
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 Commission, on request, with all relevant information relating to the notification or the maintenance of the competence of the notified body concerned.
3.   The Commission shall ensure that all sensitive information obtained in the course of its investigations pursuant to this Article is treated confidentially in accordance with Article 78.
4.   Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension or withdrawal of the notification if necessary. Where the Member State fails to take the necessary corrective measures, the Commission may, by means of an implementing act, suspend, restrict or withdraw the designation. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
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 notifying authority shall ensure that the bodies notified by it participate in the work of a group referred to in paragraph 1, directly or through designated representatives.
3.   The Commission shall provide for the exchange of knowledge and best practices between notifying authorities.
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 compliance.
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 set out in Section 2 of this Chapter or, as applicable, with the obligations set out in of Chapter V, Sections 2 and 3, of this Regulation, to the extent that those standards cover those requirements or obligations.
2.   In accordance with Article 10 of Regulation (EU) No 1025/2012, the Commission shall issue, without undue delay, standardisation requests covering all requirements set out in Section 2 of this Chapter and, as applicable, standardisation requests covering obligations set out in Chapter V, Sections 2 and 3, of this Regulation. The standardisation request shall also ask for deliverables on reporting and documentation processes to improve AI systems’ resource performance, such as reducing the high-risk AI system’s consumption of energy and of other resources during its lifecycle, and on the energy-efficient development of general-purpose AI models. When preparing a standardisation request, the Commission shall consult the Board and relevant stakeholders, including the advisory forum.
When issuing a standardisation request to European standardisation organisations, the Commission shall specify that standards have to be clear, consistent, including with the standards developed in the various sectors for products covered by the existing Union harmonisation legislation listed in Annex I, and aiming to ensure that high-risk AI systems or general-purpose AI models placed on the market or put into service in the Union meet the relevant requirements or obligations laid down in this Regulation.
The Commission shall request the European standardisation organisations to provide evidence of their best efforts to fulfil the objectives referred to in the first and the second subparagraph of this paragraph in accordance with Article 24 of Regulation (EU) No 1025/2012.
3.   The participants in the standardisation process shall seek to promote investment and innovation in AI, including through increasing legal certainty, as well as the competitiveness and growth of the Union market, to contribute to strengthening global cooperation on standardisation and taking into account existing international standards in the field of AI that are consistent with Union values, fundamental rights and interests, and to enhance multi-stakeholder governance ensuring a balanced representation of interests and the effective participation of all relevant stakeholders in accordance with Articles 5, 6, and 7 of Regulation (EU) No 1025/2012.
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 been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to Regulation (EU) 2019/881 and the references of which have been published in theOfficial Journal of the European Unionshall be presumed to comply with the cybersecurity requirements set out in Article 15 of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover those requirements.
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 years for AI systems covered by Annex I, and four years for AI systems covered by Annex III. At the request of the provider, the validity of a certificate may be extended for further periods, each not exceeding five years for AI systems covered by Annex I, and four years for AI systems covered by Annex III, based on a re-assessment in accordance with the applicable conformity assessment procedures. Any supplement to a certificate shall remain valid, provided that the certificate which it supplements is valid.
3.   Where a notified body finds that an AI system no longer meets the requirements set out in Section 2, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose restrictions on it, unless compliance with those requirements is ensured by appropriate corrective action taken by the provider of the system within an appropriate deadline set by the notified body. The notified body shall give reasons for its decision.
An appeal procedure against decisions of the notified bodies, including on conformity certificates issued, shall be available.
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 assessment certificates, any supplements to those certificates, and any quality management system approvals issued in accordance with the requirements of Annex VII;
(b) any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality management system approval issued in accordance with the requirements of Annex VII;
(b)
any refusal, restriction, suspension or withdrawal of a Union technical documentation assessment certificate or a quality management system approval issued in accordance with the requirements of Annex VII;
(c) any circumstances affecting the scope of or conditions for notification;
(c)
any circumstances affecting the scope of or conditions for notification;
(d) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
(d)
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
(e) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
(e)
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
2.   Each notified body shall inform the other notified bodies of:
(a) quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
(a)
quality management system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued;
(b) Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
(b)
Union technical documentation assessment certificates or any supplements thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or supplements thereto which it has issued.
3.   Each notified body shall provide the other notified bodies carrying out similar conformity assessment activities covering the same types of AI systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.
4.   Notified bodies shall safeguard the confidentiality of the information that they obtain, in accordance with Article 78.
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 declaration of conformity shall identify the high-risk AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be submitted to the relevant national competent authorities upon request.
2.   The EU declaration of conformity shall state that the high-risk AI system concerned meets the requirements set out in Section 2. The EU declaration of conformity shall contain the information set out in Annex V, and shall be translated into a language that can be easily understood by the national competent authorities of the Member States in which the high-risk AI system is placed on the market or made available.
3.   Where high-risk AI systems are subject to other Union harmonisation legislation which also requires an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all Union law applicable to the high-risk AI system. The declaration shall contain all the information required to identify the Union harmonisation legislation to which the declaration relates.
4.   By drawing up the EU declaration of conformity, the provider shall assume responsibility for compliance with the requirements set out in Section 2. The provider shall keep the EU declaration of conformity up-to-date as appropriate.
5.   The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex V by updating the content of the EU declaration of conformity set out in that Annex, in order to introduce elements that become necessary in light of technical progress.
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 machine-readable code or other electronic means.
3.   The CE marking shall be affixed visibly, legibly and indelibly for high-risk AI systems. Where that is not possible or not warranted on account of the nature of the high-risk AI system, it shall be affixed to the packaging or to the accompanying documentation, as appropriate.
4.   Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 43. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the provider or by the provider’s authorised representative. The identification number shall also be indicated in any promotional material which mentions that the high-risk AI system fulfils the requirements for CE marking.
5.   Where high-risk AI systems are subject to other Union law which also provides for the affixing of the CE marking, the CE marking shall indicate that the high-risk AI system also fulfil the requirements of that other law.
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 in Article 71.
2.   Before placing on the market or putting into service an AI system for which the provider has concluded that it is not high-risk according to Article 6(3), that provider or, where applicable, the authorised representative shall register themselves and that system in the EU database referred to in Article 71.
3.   Before putting into service or using a high-risk AI system listed in Annex III, with the exception of high-risk AI systems listed in point 2 of Annex III, deployers that are public authorities, Union institutions, bodies, offices or agencies or persons acting on their behalf shall register themselves, select the system and register its use in the EU database referred to in Article 71.
4.   For high-risk AI systems referred to in points 1, 6 and 7 of Annex III, in the areas of law enforcement, migration, asylum and border control management, the registration referred to in paragraphs 1, 2 and 3 of this Article shall be in a secure non-public section of the EU database referred to in Article 71 and shall include only the following information, as applicable, referred to in:
(a) Section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;
(a)
Section A, points 1 to 10, of Annex VIII, with the exception of points 6, 8 and 9;
(b) Section B, points 1 to 5, and points 8 and 9 of Annex VIII;
(b)
Section B, points 1 to 5, and points 8 and 9 of Annex VIII;
(c) Section C, points 1 to 3, of Annex VIII;
(c)
Section C, points 1 to 3, of Annex VIII;
(d) points 1, 2, 3 and 5, of Annex IX.
(d)
points 1, 2, 3 and 5, of Annex IX.
Only the Commission and national authorities referred to in Article 74(8) shall have access to the respective restricted sections of the EU database listed in the first subparagraph of this paragraph.
5.   High-risk AI systems referred to in point 2 of Annex III shall be registered at national level.
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 capabilities evaluated on the basis of appropriate technical tools and methodologies, including indicators and benchmarks;
(b) based on a decision of the Commission,ex officioor following a qualified alert from the scientific panel, it has capabilities or an impact equivalent to those set out in point (a) having regard to the criteria set out in Annex XIII.
(b)
based on a decision of the Commission,ex officioor following a qualified alert from the scientific panel, it has capabilities or an impact equivalent to those set out in point (a) having regard to the criteria set out in Annex XIII.
2.   A general-purpose AI model shall be presumed to have high impact capabilities pursuant to paragraph 1, point (a), when the cumulative amount of computation used for its training measured in floating point operations is greater than 10.
3.   The Commission shall adopt delegated acts in accordance with Article 97 to amend the thresholds listed in paragraphs 1 and 2 of this Article, as well as to supplement benchmarks and indicators in light of evolving technological developments, such as algorithmic improvements or increased hardware efficiency, when necessary, for these thresholds to reflect the state of the art.