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Chapters
4High-Risk AI Systems
Includes Classification of AI Systems as High-Risk, Requirements for High-Risk AI Systems, Obligations of Providers and Deployers, Notifying Authorities and Notified Bodies, Standards, Conformity Assessment, Certification and Regi…
Open Chapter III · Articles 6–49Classification of AI Systems as High-Risk
Classification of AI Systems as High-Risk within the EU AI Act legal library.
Open Chapter 3, Section 1 · Articles 6–7EU Database for High-Risk AI Systems
EU Database for High-Risk AI Systems in Regulation (EU) 2024/1689.
Open Chapter VIII · Articles 71Requirements for High-Risk AI Systems
Requirements for High-Risk AI Systems within the EU AI Act legal library.
Open Chapter 3, Section 2 · Articles 8–15Articles
52Classification Rules for High-risk AI Systems
…d 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 of a product, or the AI system is…
Open Article 6Obligations of Providers of High-Risk AI Systems
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; (b) indicate on the high-risk AI system or, where that is not possible, on its packaging…
Open Article 16Authorised Representatives of Providers of High-Risk AI Systems
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 provid…
Open Article 22Obligations of Deployers of High-Risk AI Systems
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…
Open Article 26Fundamental Rights Impact Assessment for High-risk AI Systems
1. Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems intended to be used in the area listed in point 2 of Annex III, deployers that are bodies governed by public law,…
Open Article 27Testing of High-risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
1. Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by providers or prospective providers of high-risk AI systems listed in Annex III or covered by Union harmonisation legis…
Open Article 60Testing of High-risk AI Systems Covered by Union Harmonisation Legislation Listed in Section B of Annex I in Real-world Conditions Outside AI Regulatory Sandboxes
…er States may allow, in accordance with this Article, the testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes by providers or prospective providers of AI enabled products covered by the Union h…
Open Article 60aEU Database for High-Risk AI Systems Listed in Annex III
…rmation referred to in paragraphs 2 and 3 of this Article concerning high-risk AI systems referred to in Article 6(2) which are registered in accordance with Articles 49 and 60 and AI systems that are not considered as high-risk p…
Open Article 71Post-market Monitoring by Providers and Post-market Monitoring Plan for High-risk AI Systems
…r that is proportionate to the nature of the AI technologies and the risks of the high-risk AI system. 2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data which may be…
Open Article 72Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III
…ason to consider that an AI system classified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of the AI system concerned in respect of…
Open Article 80Procedure at National Level for Dealing with AI Systems Presenting a Risk
1. AI systems presenting a risk shall be understood as a ‘product presenting a risk’ as defined in Article 3, point 19 of Regulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights…
Open Article 79Compliant AI Systems which Present a Risk
…arket surveillance authority of a Member State finds that although a high-risk AI system complies with this Regulation, it nevertheless presents a risk to the health or safety of persons, to fundamental rights, or to other aspects…
Open Article 82Risk Management System
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 thro…
Open Article 9Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox
…olely for the purpose of developing, training and testing certain AI systems in the sandbox when all of the following conditions are met: (a) AI systems shall be developed for safeguarding substantial public interest by a public a…
Open Article 59Market Surveillance and Control of AI Systems in the Union Market
1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective enforcement of this Regulation: (a) any reference to an economic operator under Regulation (EU) 2019/1020 shall b…
Open Article 74Market Surveillance and Control of AI Systems and Mutual Assistance
…he obligations under this Regulation in relation to the following AI systems: (a) AI systems based on general-purpose AI models where the model and the system are developed by the same provider, or by providers forming part of the…
Open Article 75AI Systems Already Placed on the Market or Put into Service and General-purpose AI Models Already Placed on the Marked
…ication of Article 5 as referred to in Article 113(3), point (a), AI systems which are components of the large-scale IT systems established by the legal acts listed in Annex X that have been placed on the market or put into servic…
Open Article 111Subject Matter
…ntric 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, again…
Open Article 1Scope
…s 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 i…
Open Article 2Definitions
…decisions that can influence physical or virtual environments; (2) ‘risk’ means the combination of the probability of an occurrence of harm and the severity of that harm; (3) ‘provider’ means a natural or legal person, public aut…
Open Article 3Processing of Special Categories of Personal Data for Bias Detection and Correction
…tly necessary to ensure bias detection and correction in relation to high-risk AI systems in accordance with Article 10(2), points (f) and (g), of this Regulation, providers of such systems may exceptionally process special catego…
Open Article 4aAmendments to Annex III
…th 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; (b…
Open Article 7Compliance with the Requirements
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 ma…
Open Article 8Data and Data Governance
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 paragra…
Open Article 10Record-Keeping
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 approp…
Open Article 12Transparency and Provision of Information to Deployers
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 a…
Open Article 13Human Oversight
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.…
Open Article 14Accuracy, Robustness and Cybersecurity
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 lifecyc…
Open Article 15Quality Management System
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,…
Open Article 17Automatically Generated Logs
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 o…
Open Article 19Corrective Actions and Duty of Information
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…
Open Article 20Cooperation with Competent Authorities
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…
Open Article 21Responsibilities Along the AI Value Chain
…loyer 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 circums…
Open Article 25Requirements Relating to Notified Bodies
…onduct. 4. Notified bodies shall be independent of the provider of a high-risk AI system in relation to which they perform conformity assessment activities. Notified bodies shall also be independent of any other operator having an…
Open Article 31Operational Obligations of Notified Bodies
1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43. 2. Notified bodies shall avoid unnecessary burdens for providers when performing…
Open Article 34Changes to Notifications
…as confirmed in writing that it will assume responsibilities for the high-risk AI systems covered by those certificates. The latter notified body shall complete a full assessment of the high-risk AI systems affected by the end of…
Open Article 36Coordination of Notified Bodies
1. The Commission shall ensure that, with regard to high-risk AI systems, appropriate coordination and cooperation between notified bodies active in the conformity assessment procedures pursuant to this Regulation are put in place…
Open Article 38Harmonised Standards and Standardisation Deliverables
1. High-risk AI systems or general-purpose AI models which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union in accordance with R…
Open Article 40Common Specifications
…ditions laid down in paragraph 1 of this Article to be fulfilled. 3. High-risk AI systems or general-purpose AI models which are in conformity with the common specifications referred to in paragraph 1, or parts of those specificat…
Open Article 41Presumption of Conformity with Certain Requirements
1. High-risk AI systems that have been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which they are intended to be used shall be presumed to comply with the r…
Open Article 42Conformity Assessment
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 A…
Open Article 43Derogation from Conformity Assessment Procedure
…se 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 protection of life and health of perso…
Open Article 46EU Declaration of Conformity
…sical 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 o…
Open Article 47CE Marking
…nciples 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 access…
Open Article 48Registration
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 r…
Open Article 49Derogations for Specific Operators
…ction or the need for compliance with the requirements in respect of high-risk AI systems. 2. Paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations…
Open Article 63Reporting of Serious Incidents
1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred. 2. The report referred to in paragraph 1 s…
Open Article 73Confidentiality
…quest only data that is strictly necessary for the assessment of the risk posed by AI systems and for the exercise of their powers in accordance with this Regulation and with Regulation (EU) 2019/1020. They shall put in place adeq…
Open Article 78Right to Explanation of Individual Decision-Making
…ion which is taken by the deployer on the basis of the output from a high-risk AI system listed in Annex III, with the exception of systems listed under point 2 thereof, and which produces legal effects or similarly significantly…
Open Article 86Codes of Conduct for Voluntary Application of Specific Requirements
…nance mechanisms, intended to foster the voluntary application to AI systems, other than high-risk AI systems, of some or all of the requirements set out in Chapter III, Section 2 taking into account the available technical soluti…
Open Article 95Evaluation and Review
…ing new area headings in Annex III; (b) amendments to the list of AI systems requiring additional transparency measures in Article 50; (c) amendments enhancing the effectiveness of the supervision and governance system. 3. By 2 Au…
Open Article 112Entry into Force and Application
…of Article 6(5), shall apply from: (i) 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III; and (ii) 2 August 2028 as regards AI systems classified as high-risk pursuant to Article…
Open Article 113Recitals
73Recital 3
AI systems can be easily deployed in a large variety of sectors of the economy and many parts of society, including across borders, and can easily circulate throughout the Union. Certain Member States have already explored the ado…
Open Recital 3Recital 7
In order to ensure a consistent and high level of protection of public interests as regards health, safety and fundamental rights, common rules for high-risk AI systems should be established. Those rules should be consistent with…
Open Recital 7Recital 9
…o the placing on the market, the putting into service and the use of high-risk AI systems should be laid down consistently with Regulation (EC) No 765/2008 of the European Parliament and of the Council (7), Decision No 768/2008/EC…
Open Recital 9Recital 22
In light of their digital nature, certain AI systems should fall within the scope of this Regulation even when they are not placed on the market, put into service, or used in the Union. This is the case, for example, where an oper…
Open Recital 22Recital 26
…introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk-based approach should be followed. That approach should tailor the type and content of such rules to the intensity and scope of t…
Open Recital 26Recital 27
While the risk-based approach is the basis for a proportionate and effective set of binding rules, it is important to recall the 2019 Ethics guidelines for trustworthy AI developed by the independent AI HLEG appointed by the Commi…
Open Recital 27Recital 33
The use of those systems for the purpose of law enforcement should therefore be prohibited, except in exhaustively listed and narrowly defined situations, where the use is strictly necessary to achieve a substantial public interes…
Open Recital 33Recital 46
High-risk AI systems should only be placed on the Union market, put into service or used if they comply with certain mandatory requirements. Those requirements should ensure that high-risk AI systems available in the Union or whos…
Open Recital 46Recital 47
AI systems could have an adverse impact on the health and safety of persons, in particular when such systems operate as safety components of products. Consistent with the objectives of Union harmonisation legislation to facilitate…
Open Recital 47Recital 49
As regards high-risk AI systems that are safety components of products or systems, or which are themselves products or systems falling within the scope of Regulation (EC) No 300/2008 of the European Parliament and of the Council (…
Open Recital 49Recital 50
As regards AI systems that are safety components of products, or which are themselves products, falling within the scope of certain Union harmonisation legislation listed in an annex to this Regulation, it is appropriate to classi…
Open Recital 50Recital 52
As regards stand-alone AI systems, namely high-risk AI systems other than those that are safety components of products, or that are themselves products, it is appropriate to classify them as high-risk if, in light of their intende…
Open Recital 52Recital 53
…so important to clarify that there may be specific cases in which AI systems referred to in pre-defined areas specified in this Regulation do not lead to a significant risk of harm to the legal interests protected under those area…
Open Recital 53Recital 54
…special category of personal data, it is appropriate to classify as high-risk several critical-use cases of biometric systems, insofar as their use is permitted under relevant Union and national law. Technical inaccuracies of AI…
Open Recital 54Recital 55
…eration of critical infrastructure, it is appropriate to classify as high-risk the AI systems intended to be used as safety components in the management and operation of critical digital infrastructure as listed in point (8) of th…
Open Recital 55Recital 56
The deployment of AI systems in education is important to promote high-quality digital education and training and to allow all learners and teachers to acquire and share the necessary digital skills and competences, including medi…
Open Recital 56Recital 57
AI systems used in employment, workers management and access to self-employment, in particular for the recruitment and selection of persons, for making decisions affecting terms of the work-related relationship, promotion and term…
Open Recital 57Recital 58
Another area in which the use of AI systems deserves special consideration is the access to and enjoyment of certain essential private and public services and benefits necessary for people to fully participate in society or to imp…
Open Recital 58Recital 59
…actions by law enforcement authorities involving certain uses of AI systems are characterised by a significant degree of power imbalance and may lead to surveillance, arrest or deprivation of a natural person’s liberty as well as…
Open Recital 59Recital 60
AI systems used in migration, asylum and border control management affect persons who are often in particularly vulnerable position and who are dependent on the outcome of the actions of the competent public authorities. The accur…
Open Recital 60Recital 61
Certain AI systems intended for the administration of justice and democratic processes should be classified as high-risk, considering their potentially significant impact on democracy, the rule of law, individual freedoms as well…
Open Recital 61Recital 62
…pean Parliament and of the Council (34), and in order to address the risks of undue external interference with the right to vote enshrined in Article 39 of the Charter, and of adverse effects on democracy and the rule of law, AI s…
Open Recital 62Recital 63
The fact that an AI system is classified as a high-risk AI system under this Regulation should not be interpreted as indicating that the use of the system is lawful under other acts of Union law or under national law compatible wi…
Open Recital 63Recital 64
To mitigate the risks from high-risk AI systems placed on the market or put into service and to ensure a high level of trustworthiness, certain mandatory requirements should apply to high-risk AI systems, taking into account the i…
Open Recital 64Recital 65
The risk-management system should consist of a continuous, iterative process that is planned and run throughout the entire lifecycle of a high-risk AI system. That process should be aimed at identifying and mitigating the relevant…
Open Recital 65Recital 66
Requirements should apply to high-risk AI systems as regards risk management, the quality and relevance of data sets used, technical documentation and record-keeping, transparency and the provision of information to deployers, hum…
Open Recital 66Recital 67
High-quality data and access to high-quality data plays a vital role in providing structure and in ensuring the performance of many AI systems, especially when techniques involving the training of models are used, with a view to e…
Open Recital 67Recital 68
For the development and assessment of high-risk AI systems, certain actors, such as providers, notified bodies and other relevant entities, such as European Digital Innovation Hubs, testing experimentation facilities and researche…
Open Recital 68Recital 70
…others from the discrimination that might result from the bias in AI systems, the providers should, exceptionally, to the extent that it is strictly necessary for the purpose of ensuring bias detection and correction in relation t…
Open Recital 70Recital 71
Having comprehensible information on how high-risk AI systems have been developed and how they perform throughout their lifetime is essential to enable traceability of those systems, verify compliance with the requirements under t…
Open Recital 71Recital 72
To address concerns related to opacity and complexity of certain AI systems and help deployers to fulfil their obligations under this Regulation, transparency should be required for high-risk AI systems before they are placed on t…
Open Recital 72Recital 73
High-risk AI systems should be designed and developed in such a way that natural persons can oversee their functioning, ensure that they are used as intended and that their impacts are addressed over the system’s lifecycle. To tha…
Open Recital 73Recital 74
High-risk AI systems should perform consistently throughout their lifecycle and meet an appropriate level of accuracy, robustness and cybersecurity, in light of their intended purpose and in accordance with the generally acknowled…
Open Recital 74Recital 75
Technical robustness is a key requirement for high-risk AI systems. They should be resilient in relation to harmful or otherwise undesirable behaviour that may result from limitations within the systems or the environment in which…
Open Recital 75Recital 76
Cybersecurity plays a crucial role in ensuring that AI systems are resilient against attempts to alter their use, behaviour, performance or compromise their security properties by malicious third parties exploiting the system’s vu…
Open Recital 76Recital 77
…ments related to robustness and accuracy set out in this Regulation, high-risk AI systems which fall within the scope of a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for produ…
Open Recital 77Recital 78
…requirements for products with digital elements and classified as a high-risk AI system under this Regulation. However, this rule should not result in reducing the necessary level of assurance for critical products with digital e…
Open Recital 78Recital 80
…asis with others, to information and communications technologies and systems, and to ensure respect for privacy for persons with disabilities. Given the growing importance and use of AI systems, the application of universal design…
Open Recital 80Recital 81
…n and establish a robust post-market monitoring system. Providers of high-risk AI systems that are subject to obligations regarding quality management systems under relevant sectoral Union law should have the possibility to includ…
Open Recital 81Recital 82
…the compliance of an AI system. Therefore, prior to making their AI systems available in the Union, providers established in third countries should, by written mandate, appoint an authorised representative established in the Unio…
Open Recital 82Recital 84
…oyer or other third-party should be considered to be a provider of a high-risk AI system and therefore assume all the relevant obligations. This would be the case if that party puts its name or trademark on a high-risk AI system a…
Open Recital 84Recital 85
General-purpose AI systems may be used as high-risk AI systems by themselves or be components of other high-risk AI systems. Therefore, due to their particular nature and in order to ensure a fair sharing of responsibilities along…
Open Recital 85Recital 86
…ovider has not expressly excluded the change of the AI system into a high-risk AI system, the former provider should nonetheless closely cooperate and make available the necessary information and provide the reasonably expected te…
Open Recital 86Recital 88
Along the AI value chain multiple parties often supply AI systems, tools and services but also components or processes that are incorporated by the provider into the AI system with various objectives, including the model training,…
Open Recital 88Recital 90
…and recommend voluntary model contractual terms between providers of high-risk AI systems and third parties that supply tools, services, components or processes that are used or integrated in high-risk AI systems, to facilitate th…
Open Recital 90Recital 91
Given the nature of AI systems and the risks to safety and fundamental rights possibly associated with their use, including as regards the need to ensure proper monitoring of the performance of an AI system in a real-life setting,…
Open Recital 91Recital 92
…and of the Council (39), on decisions to put into service or use AI systems. It remains necessary to ensure information of workers and their representatives on the planned deployment of high-risk AI systems at the workplace where…
Open Recital 92Recital 93
Whilst risks related to AI systems can result from the way such systems are designed, risks can as well stem from how such AI systems are used. Deployers of high-risk AI system therefore play a critical role in ensuring that funda…
Open Recital 93Recital 96
…ficiently ensure that fundamental rights are protected, deployers of high-risk AI systems that are bodies governed by public law, or private entities providing public services and deployers of certain high-risk AI systems listed i…
Open Recital 96Recital 122
…se of harmonised standards and common specifications, providers of a high-risk AI system that has been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which the…
Open Recital 122Recital 123
In order to ensure a high level of trustworthiness of high-risk AI systems, those systems should be subject to a conformity assessment prior to their placing on the market or putting into service.
Open Recital 123Recital 124
…mise the burden on operators and avoid any possible duplication, for high-risk AI systems related to products which are covered by existing Union harmonisation legislation based on the New Legislative Framework, the compliance of…
Open Recital 124Recital 125
Given the complexity of high-risk AI systems and the risks that are associated with them, it is important to develop an adequate conformity assessment procedure for high-risk AI systems involving notified bodies, so-called third p…
Open Recital 125Recital 128
…e that whenever a change occurs which may affect the compliance of a high-risk AI system with this Regulation (e.g. change of operating system or software architecture), or when the intended purpose of the system changes, that AI…
Open Recital 128Recital 129
High-risk AI systems should bear the CE marking to indicate their conformity with this Regulation so that they can move freely within the internal market. For high-risk AI systems embedded in a product, a physical CE marking shoul…
Open Recital 129Recital 130
…uthorise the placing on the market or the putting into service of AI systems which have not undergone a conformity assessment. In duly justified situations, as provided for in this Regulation, law enforcement authorities or civil…
Open Recital 130Recital 131
…ell as to increase the transparency towards the public, providers of high-risk AI systems other than those related to products falling within the scope of relevant existing Union harmonisation legislation, as well as providers who…
Open Recital 131Recital 132
Certain AI systems intended to interact with natural persons or to generate content may pose specific risks of impersonation or deception irrespective of whether they qualify as high-risk or not. In certain circumstances, the use…
Open Recital 132Recital 141
…rate the process of development and the placing on the market of the high-risk AI systems listed in an annex to this Regulation, it is important that providers or prospective providers of such systems may also benefit from a speci…
Open Recital 141Recital 146
…of protection and the need for compliance with the requirements for high-risk AI systems. The Commission should develop guidelines to specify the elements of the quality management system to be fulfilled in this simplified manner…
Open Recital 146Recital 155
In order to ensure that providers of high-risk AI systems can take into account the experience on the use of high-risk AI systems for improving their systems and the design and development process or can take any possible correcti…
Open Recital 155Recital 157
…hould be set for ensuring adequate and timely enforcement against AI systems presenting a risk to health, safety and fundamental rights. The procedure for such AI systems presenting a risk should be applied to high-risk AI systems…
Open Recital 157Recital 158
Union financial services law includes internal governance and risk-management rules and requirements which are applicable to regulated financial institutions in the course of provision of those services, including when they make u…
Open Recital 158Recital 159
Each market surveillance authority for high-risk AI systems in the area of biometrics, as listed in an annex to this Regulation insofar as those systems are used for the purposes of law enforcement, migration, asylum and border co…
Open Recital 159Recital 160
…n relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present a serious risk across two or more Member States. Joint activities to promote compliance should be carried out in a…
Open Recital 160Recital 161
…sibilities and competences at Union and national level as regards AI systems that are built on general-purpose AI models. To avoid overlapping competences, where an AI system is based on a general-purpose AI model and the model an…
Open Recital 161Recital 165
The development of AI systems other than high-risk AI systems in accordance with the requirements of this Regulation may lead to a larger uptake of ethical and trustworthy AI in the Union. Providers of AI systems that are not high…
Open Recital 165Recital 166
It is important that AI systems related to products that are not high-risk in accordance with this Regulation and thus are not required to comply with the requirements set out for high-risk AI systems are nevertheless safe when pl…
Open Recital 166Recital 171
…e a deployer’s decision is based mainly upon the output from certain high-risk AI systems that fall within the scope of this Regulation and where that decision produces legal effects or similarly significantly affects those person…
Open Recital 171Recital 173
…he conditions under which an AI system is not to be considered to be high-risk, the list of high-risk AI systems, the provisions regarding technical documentation, the content of the EU declaration of conformity the provisions reg…
Open Recital 173Recital 174
…sion should carry out an assessment of the need to amend the list of high-risk AI systems and the list of prohibited practices once a year. Moreover, by 2 August 2028 and every four years there after, the Commission should evaluat…
Open Recital 174Recital 177
…ion to the market, including by ensuring continuity of the use of AI systems, it is appropriate that this Regulation applies to the high-risk AI systems that have been placed on the market or put into service before the general da…
Open Recital 177Recital 178
Providers of high-risk AI systems are encouraged to start to comply, on a voluntary basis, with the relevant obligations of this Regulation already during the transitional period.
Open Recital 178Annexes
5Annex III
High-risk AI systems referred to in Article 6(2) High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas: 1. Biometrics, in so far as their use is permitted under relevant Union or nat…
Open Annex IIIAnnex VII
…lity management system for the design, development and testing of AI systems pursuant to Article 17 shall be examined in accordance with point 3 and shall be subject to surveillance as specified in point 5. The technical documenta…
Open Annex VIIAnnex VIII
Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49 Section A — Information to be submitted by providers of high-risk AI systems in accordance with Article 49(1) The following in…
Open Annex VIIIAnnex IX
Information to be submitted upon the registration of high-risk AI systems listed in Annex III in relation to testing in real world conditions in accordance with Article 60 The following information shall be provided and thereafter…
Open Annex IXAnnex XIV: List of Codes for the Notification Procedure
The list of codes, categories and corresponding types of AI systems for the purpose of the notification procedure referred to in Article 30 specifying the scope of the designation as notified bodies 1. Introduction Conformity asse…
Open Annex XIV