### (51) 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 vulnerabilities. cyberattacks against ai systems can leverage ai specific assets , such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks) , or exploit vulnerabilities in the ai system’s digital assets or the underlying ict infrastructure. to ensure a level of cybersecurity appropriate to the risks , suitable measures should therefore be taken by the providers of high-risk ai systems , also taking into account as appropriate the underlying ict infrastructure. ### (51) 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 vulnerabilities. cyberattacks against ai systems can leverage ai specific assets , such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks) , or exploit vulnerabilities in the ai system’s digital assets or the underlying ict infrastructure. to ensure a level of cybersecurity appropriate to the risks , state-of-the-art measures should therefore be taken into account by the providers of high-risk ai systems but also by the national competent authorities , market surveillance authorities and notified bodies that are accessing the data of providers of high-risk ai systems , next to appropriate underlying ict infrastructure. it should be further taken into account that ai in the form of machine learning is a critical defence against malware representing a legitimate interest of the ai user.


### (51) 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 vulnerabilities. cyberattacks against ai systems can leverage ai specific assets , such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks) , or exploit vulnerabilities in the ai system’s digital assets or the underlying ict infrastructure. to ensure a level of cybersecurity appropriate to the risks , suitable measures should therefore be taken by the providers of high-risk ai systems , also taking into account as appropriate the underlying ict infrastructure. ### (51) 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 vulnerabilities. cyberattacks against ai systems can leverage ai specific assets , such as training data sets (e.g. data poisoning) or trained models (e.g. adversarial attacks) , or exploit vulnerabilities in the ai system’s digital assets or the underlying ict infrastructure. to ensure a level of cybersecurity appropriate to the risks , suitable measures should therefore be taken by the providers of high-risk ai systems , as well as the competent public authorities accessing the data of providers of high-risk ai systems , also taking into account as appropriate the underlying ict infrastructure.


### (54) the provider should establish a sound quality management system , ensure the accomplishment of the required conformity assessment procedure , draw up the relevant documentation and establish a robust post-market monitoring system. public authorities which put into service high-risk ai systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level , as appropriate , taking into account the specificities of the sector and the competences and organisation of the public authority in question. ### (54) unless the provider has already implemented a risk management system warranting quality and conformity , the provider should establish a sound quality management system , ensure the accomplishment of the required conformity assessment procedure , draw up the relevant documentation and establish a robust post-market monitoring system. public authorities which put into service high-risk ai systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level , as appropriate , taking into account the specificities of the sector and the competences and organisation of the public authority in question.


### (54) the provider should establish a sound quality management system , ensure the accomplishment of the required conformity assessment procedure , draw up the relevant documentation and establish a robust post-market monitoring system. public authorities which put into service high-risk ai systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level , as appropriate , taking into account the specificities of the sector and the competences and organisation of the public authority in question. ### (54) the provider should establish a sound quality management system , ensure the accomplishment of the required conformity assessment procedure , draw up the relevant documentation and establish a robust post-market monitoring system. public authorities which put into service high-risk ai systems for their own use may adopt and implement the rules for the quality management system as part of the quality management system adopted at a national or regional level , as appropriate , taking into account the specificities of the sector and the competences and organisation of the public authority in question. where this overlaps with any relevant and applicable sectoral legislation , the relevant terminology should be appropriately harmonised to avoid any unnecessary fragmentation.


### (64) given the more extensive experience of professional pre-market certifiers in the field of product safety and the different nature of risks involved , it is appropriate to limit , at least in an initial phase of application of this regulation , the scope of application of third-party conformity assessment for high-risk ai systems other than those related to products. therefore , the conformity assessment of such systems should be carried out as a general rule by the provider under its own responsibility , with the only exception of ai systems intended to be used for the remote biometric identification of persons , for which the involvement of a notified body in the conformity assessment should be foreseen , to the extent they are not prohibited. ### (64) given the more extensive experience of professional pre-market certifiers in the field of product safety and the different nature of risks involved , it is appropriate to limit , at least in an initial phase of application of this regulation , the scope of application of third-party conformity assessment for high-risk ai systems other than those related to products. therefore , the conformity assessment of such systems should be carried out as a general rule by the provider under its own responsibility , with the only exception of ai systems intended to be used for the remote biometric identification of persons , for which the involvement of a notified body in the conformity assessment should be foreseen.


### (67) 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. member states should not create unjustified obstacles to the placing on the market or putting into service of high-risk ai systems that comply with the requirements laid down in this regulation and bear the ce marking. ### (67) 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. member states should not create obstacles to the placing on the market or putting into service of high-risk ai systems that comply with the requirements laid down in this regulation and bear the ce marking.


### (71) artificial intelligence is a rapidly developing family of technologies that requires novel forms of regulatory oversight and a safe space for experimentation , while ensuring responsible innovation and integration of appropriate safeguards and risk mitigation measures. to ensure a legal framework that is innovation-friendly , future-proof and resilient to disruption , national competent authorities from one or more member states should be encouraged to establish artificial intelligence regulatory sandboxes to facilitate the development and testing of innovative ai systems under strict regulatory oversight before these systems are placed on the market or otherwise put into service. ### (71) artificial intelligence is a rapidly developing family of technologies that requires novel forms of regulatory oversight and a safe space for experimentation , while ensuring responsible innovation and integration of appropriate safeguards and risk mitigation measures. to ensure a legal framework that is innovation-friendly , future-proof and resilient to disruption , national competent authorities from one or more member states should establish artificial intelligence regulatory sandboxes and make such regulatory sandboxes widely available throughout the union , in order to facilitate the development and testing of innovative ai systems under strict regulatory oversight before these systems are placed on the market or otherwise put into service.


### specific requirements for high-risk ai systems and obligations for operators of such systems; ### specific requirements for high-risk ai systems and obligations for operators of such systems , unless these systems are already covered by sector-specific regulation;


### 2. for high-risk ai systems that are safety components of products or systems , or which are themselves products or systems , falling within the scope of the following acts , only article 84 of this regulation shall apply: ### 2. for ai systems classified as high-risk ai in accordance with article 6 related to products covered by union harmonisation legislation listed in annex ii , section b , only article 84 of this regulation shall apply:


### 2. for high-risk ai systems that are safety components of products or systems , or which are themselves products or systems , falling within the scope of the following acts , only article 84 of this regulation shall apply: ### 2. in order to ensure legal certainty , preserve the existing legislation and avoid duplication , only article 84 of this regulation shall apply for high-risk ai systems that are safety components of products or systems , or which are themselves products or systems , falling within the scope of the following acts:


### 2. for high-risk ai systems that are safety components of products or systems , or which are themselves products or systems , falling within the scope of the following acts , only article 84 of this regulation shall apply: ### 2. for high-risk ai systems that are safety components of products or systems , or which are themselves products or systems and that fall within the scope of the listed acts in annex ii - section b , only article 84 of this regulation shall apply.


### 3. this regulation shall not apply to ai systems developed or used exclusively for military purposes. ### 3. this regulation shall not apply to ai systems developed or used exclusively for military or national security purposes


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) ‘artificial intelligence system’ (ai system) means a system that:


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) ‘artificial intelligence system’ (ai system) means a system that combines these three criteria:


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) ‘artificial intelligence system’ (ai system) means a machine-based system that is developed with one or more of the techniques and approaches listed in annex i and is capable of influencing the environment by producing an output(predictions , recommendations , or decisions) for a given set of objectives. it uses machine and/or human-based data and inputs to (i) perceive real and/or virtual environments; (ii) abstract these perceptions into models through analysis in an automated manner (e.g. with machine learning) , or manually; and (iii) use model inference to formulate options for outcomes. ai systems are designed to operate with varying levels of autonomy;


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) ‘artificial intelligence system’ (ai system) means a system that


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) ‘artificial intelligence system’ (ai system) means a system that operates with varying degrees of autonomy , uses one or more of the techniques and approaches listed in annex i and can , for human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with and that cannot be fully predicted by the natural person developing the system;


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , indispensably with some degree of autonomy , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with;


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives and with varying levels of autonomy , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with;


### (1) ‘artificial intelligence system’ (ai system) means software that is developed with one or more of the techniques and approaches listed in annex i and can , for a given set of human-defined objectives , generate outputs such as content , predictions , recommendations , or decisions influencing the environments they interact with; ### (1) ‘artificial intelligence system’ (ai system) means a machine-based system that can , for a given set of human-defined objectives , make predictions , recommendations , or decisions influencing real or virtual environments and is designed to operate with varying levels of autonomy;


### (2) ‘provider’ means a natural or legal person , public authority , agency or other body that develops an ai system or that has an ai system developed with a view to placing it on the market or putting it into service under its own name or trademark , whether for payment or free of charge; ### (2) ‘provider’ means a natural or legal person , public authority , agency or other body that develops an ai system or that has an ai system developed and places that system on the market or puts it into service under its own name or trademark , whether for payment or free of charge;


### (2) ‘provider’ means a natural or legal person , public authority , agency or other body that develops an ai system or that has an ai system developed with a view to placing it on the market or putting it into service under its own name or trademark , whether for payment or free of charge; ### (2) ‘provider’ means a natural or legal person , public authority , agency or other body that places an ai system on the market or puts it into service under its own name or trademark , whether for payment or free of charge or that adapts general purpose ai systems to an intended purpose;


### (4) ‘user’ means any natural or legal person , public authority , agency or other body using an ai system under its authority , except where the ai system is used in the course of a personal non-professional activity; ### (4) ‘user’ means any natural or legal person , public authority , agency or other body using an ai system under its authority;


### (4) ‘user’ means any natural or legal person , public authority , agency or other body using an ai system under its authority , except where the ai system is used in the course of a personal non-professional activity; ### (4) ‘deployer’ means any natural or legal person , public authority , agency or other body using an ai system under its authority , except where the ai system is used in the course of a personal non-professional activity;


### (12) ‘intended purpose’ means the use for which an ai system is intended by the provider , including the specific context and conditions of use , as specified in the information supplied by the provider in the instructions for use , promotional or sales materials and statements , as well as in the technical documentation; ### (12) ‘intended purpose’ means the use for which an ai system is intended by the provider , including the specific context and conditions of use , as specified in the information supplied by the provider in the instructions for use , promotional or sales materials and statements , as well as in the technical documentation. general purpose ai systems shall not be considered as having an intended purpose within the meaning of this regulation;


### (13) ‘reasonably foreseeable misuse’ means the use of an ai system in a way that is not in accordance with its intended purpose , but which may result from reasonably foreseeable human behaviour or interaction with other systems; ### deleted


### (13) ‘reasonably foreseeable misuse’ means the use of an ai system in a way that is not in accordance with its intended purpose , but which may result from reasonably foreseeable human behaviour or interaction with other systems; ### (13) ‘reasonably foreseeable misuse’ means the use of an ai system in a way that is not in accordance with its intended purpose and with the specific context and conditions of use established by the provider , but which may result from reasonably foreseeable human behaviour or interaction with other systems;


### (13) ‘reasonably foreseeable misuse’ means the use of an ai system in a way that is not in accordance with its intended purpose , but which may result from reasonably foreseeable human behaviour or interaction with other systems; ### (13) ‘reasonably foreseeable misuse’ means the use of an ai system within its intended purpose , but not in accordance with the specific context and conditions of use established by the provider and in a way which may result from reasonably foreseeable human behaviour or interaction with other systems;


### (13) ‘reasonably foreseeable misuse’ means the use of an ai system in a way that is not in accordance with its intended purpose , but which may result from reasonably foreseeable human behaviour or interaction with other systems; ### (13) ‘reasonably foreseeable misuse’ means the use of an ai system in a way that is not in accordance with its intended purpose , but which may result from known and reasonably foreseeable human behaviour;


### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property; ### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property , but which is not necessary in order for the product or system to function;


### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property; ### (14) ‘safety component of a product or system’ means , in line with the relevant union harmonisation legislation listed in annex ii , a component of a product or of a system which fulfils a direct and critical safety function for that product or system so that its malfunction endagers the health and safety of persons;


### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system or the failure or malfunctioning of which endangers the health and safety of persons or property; ### (14) ‘safety component of a product or system’ means a component of a product or of a system which fulfils a safety function for that product or system so that its malfunctioning endangers the health and safety of persons or property;


### (44) ‘serious incident’ means any incident that directly or indirectly leads , might have led or might lead to any of the following: ### (44) ’serious incident’ means any incident or malfunctioning of an ai system that directly or indirectly leads to any of the following:


### article 4 ### deleted


### the commission is empowered to adopt delegated acts in accordance with article 73 to amend the list of techniques and approaches listed in annex i , in order to update that list to market and technological developments on the basis of characteristics that are similar to the techniques and approaches listed therein. ### the commission is empowered to adopt delegated acts in accordance with article 73 to amend the list of techniques and approaches listed in annex i within the scope of the definition of an ai system as provided for in article 3(1) , in order to update that list to market and technological developments on the basis of characteristics that are similar to the techniques and approaches listed therein.


### the placing on the market , putting into service or use of an ai system that deploys subliminal techniques beyond a person’s consciousness in order to materially distort a person’s behaviour in a manner that causes or is likely to cause that person or another person physical or psychological harm; ### the placing on the market , putting into service or use of an ai system that deploys subliminal techniques beyond a person’s consciousness in order to materially distort a person’s behaviour in a manner intended to cause that person or another person physical or psychological harm;


### the placing on the market , putting into service or use of an ai system that deploys subliminal techniques beyond a person’s consciousness in order to materially distort a person’s behaviour in a manner that causes or is likely to cause that person or another person physical or psychological harm; ### the placing on the market , putting into service or use of an ai system that deploys subliminal techniques beyond a person’s consciousness in order to materially distort a person’s behaviour in a manner that causes or is likely to cause that person or another person physical or psychological harm that could be predicted with due diligence;


### detrimental or unfavourable treatment of certain natural persons or whole groups thereof in social contexts which are unrelated to the contexts in which the data was originally generated or collected; ### detrimental or unfavourable treatment of certain natural persons or groups thereof in social contexts which are unrelated to the contexts in which the data was originally generated or collected;


### (ii) detrimental or unfavourable treatment of certain natural persons or whole groups thereof that is unjustified or disproportionate to their social behaviour or its gravity; ### (ii) detrimental or unfavourable treatment of certain natural persons or groups thereof that is unjustified or disproportionate to their social behaviour or its gravity;


### the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement , unless and in as far as such use is strictly necessary for one of the following objectives: ### deleted


### the targeted search for specific potential victims of crime , including missing children; ### deleted


### (ii) the prevention of a specific , substantial and imminent threat to the life or physical safety of natural persons or of a terrorist attack; ### deleted


### (iii) the detection , localisation , identification or prosecution of a perpetrator or suspect of a criminal offence referred to in article 2(2) of council framework decision 2002/584/jha62 and punishable in the member state concerned by a custodial sentence or a detention order for a maximum period of at least three years , as determined by the law of that member state. ### deleted


### 2. the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purpose of law enforcement for any of the objectives referred to in paragraph 1 point d) shall take into account the following elements: ### deleted


### 3. as regards paragraphs 1 , point (d) and 2 , each individual use for the purpose of law enforcement of a ‘real-time’ remote biometric identification system in publicly accessible spaces shall be subject to a prior authorisation granted by a judicial authority or by an independent administrative authority of the member state in which the use is to take place , issued upon a reasoned request and in accordance with the detailed rules of national law referred to in paragraph 4. however , in a duly justified situation of urgency , the use of the system may be commenced without an authorisation and the authorisation may be requested only during or after the use. ### deleted


### the competent judicial or administrative authority shall only grant the authorisation where it is satisfied , based on objective evidence or clear indications presented to it , that the use of the ‘real-time’ remote biometric identification system at issue is necessary for and proportionate to achieving one of the objectives specified in paragraph 1 , point (d) , as identified in the request. in deciding on the request , the competent judicial or administrative authority shall take into account the elements referred to in paragraph 2. ### deleted


### 1. irrespective of whether an ai system is placed on the market or put into service independently from the products referred to in points (a) and (b) , that ai system shall be considered high-risk where both of the following conditions are fulfilled: ### 1. an ai system that is itself a product covered by the union harmonisation legislation listed in annex ii shall be considered as high risk if it is required to undergo a third-party conformity assessment with a view to the placing on the market or putting into service of that product pursuant to the above mentioned legislation.


### 1. irrespective of whether an ai system is placed on the market or put into service independently from the products referred to in points (a) and (b) , that ai system shall be considered high-risk where both of the following conditions are fulfilled: ### 1. 1. an ai system that is itself a product covered by the union harmonisation legislation listed in annex ii shall be considered as high risk if it is required to undergo a third-party conformity assessment with a view to the placing on the market or putting into service of that product pursuant to the above mentioned legislation.


### 2. in addition to the high-risk ai systems referred to in paragraph 1 , ai systems referred to in annex iii shall also be considered high-risk. ### 2. an ai system intended to be used as a safety component of a product covered by the legislation referred to in paragraph 1 shall be considered as high risk if it is required to undergo a third-party conformity assessment with a view to the placing on the market or putting into service of that product pursuant to above mentioned legislation. this provision shall apply irrespective of whether the ai system is placed on the market or put into service independently from the product.


### 2. in addition to the high-risk ai systems referred to in paragraph 1 , ai systems referred to in annex iii shall also be considered high-risk. ### 2. in addition to the high-risk ai systems referred to in paragraph 1 , and in accordance with paragraph -1 of this article , ai systems referred to in annex iii shall also be considered high-risk.


### [...] ### deleted


### 1. the commission is empowered to adopt delegated acts in accordance with article 73 to update the list in annex iii by adding high-risk ai systems where both of the following conditions are fulfilled: ### 1. the commission is empowered to adopt delegated acts in accordance with article 73 , after consulting stakeholders and carrying out an impact study , to update the list in annex iii by adding high-risk ai systems where both of the following conditions are fulfilled:


### the ai systems pose a risk of harm to the health and safety , or a risk of adverse impact on fundamental rights , that is , in respect of its severity and probability of occurrence , equivalent to or greater than the risk of harm or of adverse impact posed by the high-risk ai systems already referred to in annex iii. ### the ai systems pose a serious risk of harm to the health and safety , or a serious risk of adverse impact on fundamental rights , that is , in respect of its severity and probability of occurrence , equivalent to or greater than the risk of harm or of adverse impact posed by the high-risk ai systems already referred to in annex iii.


### 1. high-risk ai systems shall comply with the requirements established in this chapter. ### 1. high-risk ai systems shall , taking into account the generally acknowledged state of the art and industry standards , comply with the requirements established in this chapter.


### 2. the intended purpose of the high-risk ai system and the risk management system referred to in article 9 shall be taken into account when ensuring compliance with those requirements. ### 2. the intended purpose of the high-risk ai system and the risk management system referred to in article 9 shall be taken into account when ensuring compliance with the relevant requirements depending of the type of risks posed.


### 1. a risk management system shall be established , implemented , documented and maintained in relation to high-risk ai systems. ### 1. a risk management system shall be established , implemented , documented and maintained in relation to high-risk ai systems.


### 1. a risk management system shall be established , implemented , documented and maintained in relation to high-risk ai systems. ### 1. a risk management system shall be maintained in relation to high-risk ai systems.


### 2. the risk management system shall consist of a continuous iterative process run throughout the entire lifecycle of a high-risk ai system , requiring regular systematic updating. it shall comprise the following steps: ### 2. the risk management system shall comprise the following steps:


### identification and analysis of the known and foreseeable risks associated with each high-risk ai system; ### identification and analysis of the known and reasonable foreseeable risks of harms most likely to occur to the health , safety or fundamental rights in view of the intended purpose of the high-risk ai system;


### identification and analysis of the known and foreseeable risks associated with each high-risk ai system; ### identification and analysis of the known and foreseeable risks to the health and safety or fundamental rights of a person associated with each high-risk ai system;


### evaluation of other possibly arising risks based on the analysis of data gathered from the post-market monitoring system referred to in article 61; ### evaluation of other possibly arising risks based on the analysis of data gathered from the post-market monitoring system;


### evaluation of other possibly arising risks based on the analysis of data gathered from the post-market monitoring system referred to in article 61; ### evaluation of new risks consistent with those described in paragraph (2a) of this article and identified based on the analysis of data gathered from the post-market monitoring system referred to in article 61;


### 3. the risk management measures referred to in paragraph 2 , point (d) shall give due consideration to the effects and possible interactions resulting from the combined application of the requirements set out in this chapter 2. they shall take into account the generally acknowledged state of the art , including as reflected in relevant harmonised standards or common specifications. ### 3. the risk management measures shall give due consideration to the effects and possible interactions resulting from the combined application of the requirements set out in this chapter 2. they shall take into account the generally acknowledged state of the art , including as reflected in relevant harmonised standards or common specifications.


### 3. the risk management measures referred to in paragraph 2 , point (d) shall give due consideration to the effects and possible interactions resulting from the combined application of the requirements set out in this chapter 2. they shall take into account the generally acknowledged state of the art , including as reflected in relevant harmonised standards or common specifications. ### 3. the risk management measures referred to in paragraph 2 , point (d) shall give due consideration to the effects and possible interactions resulting from the combined application of the requirements set out in this chapter 2 , with a view to treating risks effectively while ensuring an appropriate and proportionate implementation of the requirements. they shall take into account the generally acknowledged state of the art , including as reflected in relevant harmonised standards.


### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks shall be communicated to the user. ### 4. the risk management measures shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks shall be communicated to the user.


### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks shall be communicated to the user. ### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any significant residual risk of the high-risk ai systems is reasonably judged to be acceptable , having regards to the benefits that the high-risk ai system is reasonably expected to deliver and provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. significant residual risks shall be communicated to the user.


### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose or under conditions of reasonably foreseeable misuse. those residual risks shall be communicated to the user. ### 4. the risk management measures referred to in paragraph 2 , point (d) shall be such that any residual risk associated with each hazard as well as the overall residual risk of the high-risk ai systems is judged acceptable , provided that the high-risk ai system is used in accordance with its intended purpose. those residual risks shall be communicated to the user.


### 1. high-risk ai systems which make use of techniques involving the training of 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. ### 1. high-risk ai systems which make use of techniques involving the training of 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 , where applicable.


### 1. high-risk ai systems which make use of techniques involving the training of 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. ### 1. high-risk ai systems which make use of techniques involving the training of models with data shall be developed , to the extent technically feasible , on the basis of training , validation and testing data sets that meet the quality criteria referred to in paragraphs 2 to 5.


### 2. training , validation and testing data sets shall be subject to appropriate data governance and management practices. those practices shall concern in particular , ### 2. to the extent technically feasible , training , validation and testing data sets shall be subject to appropriate data governance and management practices. those practices shall concern in particular ,


### examination in view of possible biases; ### examination in view of possible biases , in particular deviations that could affect health and safety of people or lead to discrimination;


### examination in view of possible biases; ### examination in view of possible biases , defined as a statistical error or a top-down introduction of assumptions harmful to an individual , that are likely to affect health and safety of persons or lead to discrimination prohibited by union law;


### examination in view of possible biases; ### examination in view of possible biases that are likely to affect the physical health and safety of persons or lead to discrimination prohibited by union law; ;


### 3. training , validation and testing data sets shall be relevant , representative , free of errors and complete. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof. ### 3. training , validation and testing data sets should be sufficiently relevant , representative and free of errors and complete in view of the intended purpose of the system. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof.


### 3. training , validation and testing data sets shall be relevant , representative , free of errors and complete. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof. ### 3. training , validation and testing data sets shall be relevant and representative. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof.


### 3. training , validation and testing data sets shall be relevant , representative , free of errors and complete. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof. ### 3. training , validation and testing data sets should be relevant , representative , free of errors , complete and consistent with the generally acknowledged state of the art. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof.


### 3. training , validation and testing data sets shall be relevant , representative , free of errors and complete. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof. ### 3. providers and users shall , when technically feasible and necessary to avoid harm , ensure that training , validation and testing datasets shall be relevant , representative , and establish reasonable procedures to mitigate errors and incomplete data sets , in view of the intended purpose of the high-risk ai system and the context of its use free of errors and complete. they shall have the appropriate statistical properties , including , where applicable , as regards the persons or groups of persons on which the high-risk ai system is intended to be used. these characteristics of the data sets may be met at the level of individual data sets or a combination thereof.


### 4. training , validation and testing data sets shall take into account , to the extent required by the intended purpose , the characteristics or elements that are particular to the specific geographical , behavioural or functional setting within which the high-risk ai system is intended to be used. ### 4. training , validation and testing data sets shall take into account , to the extent technically feasible and required by the intended purpose , the characteristics or elements that are particular to the specific geographical , behavioural or functional setting within which the high-risk ai system is intended to be used.


### 2. high-risk ai systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that include concise , complete , correct and clear information that is relevant , accessible and comprehensible to users. ### 2. high-risk ai systems shall be accompanied by instructions for use in an appropriate digital format or otherwise that include concise , correct and clear information that is relevant and accessible to users.


### 4. the measures referred to in paragraph 3 shall enable the individuals to whom human oversight is assigned to do the following , as appropriate to the circumstances: ### 4. the measures referred to in paragraph 3 shall enable the individuals to whom human oversight is assigned to do the following , where necessary and as appropriate to the circumstances:


### fully understand the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible; ### have an appropriate understanding of the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible;


### fully understand the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible; ### understand the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible;


### fully understand the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible; ### sufficiently understand the capacities and limitations of the high-risk ai system and be able to duly monitor its operation , so that signs of anomalies , dysfunctions and unexpected performance can be detected and addressed as soon as possible;


### be able to decide , in any particular situation , not to use the high-risk ai system or otherwise disregard , override or reverse the output of the high-risk ai system; ### be able to decide , in any particular situation , not to use the high-risk ai system or otherwise disregard , override or reverse the output of the high-risk ai system unless the ai system is considered state-of-the-art and such human intervention is deemed to increase risks or otherwise negatively impact the system’s performance.


### be able to decide , in any particular situation , not to use the high-risk ai system or otherwise disregard , override or reverse the output of the high-risk ai system; ### be able to decide , in any particular situation , not to use the high-risk ai system or otherwise disregard , override or reverse the output of the high-risk ai system unless the ai system is considered state-of-the-art and such human intervention is deemed to increase risks or otherwise negatively impact the system’s performance;


### be able to intervene on the operation of the high-risk ai system or interrupt the system through a “stop” button or a similar procedure. ### be able to intervene on the operation of the high-risk ai system or interrupt the system through a “stop” button or a similar procedure unless the ai system is considered state-of-the-art and such human intervention is deemed to increase risks or otherwise negatively impact the system’s performance.


### be able to intervene on the operation of the high-risk ai system or interrupt the system through a “stop” button or a similar procedure. ### be able to intervene on the operation of the high-risk ai system , put the system into fail-safe mode , put the system into manual control mode or stop the system through a “stop” button or a similar procedure.


### be able to intervene on the operation of the high-risk ai system or interrupt the system through a “stop” button or a similar procedure. ### be able to intervene on the operation of the high-risk ai system or interrupt the system through a “stop” button or a similar procedure provided that this does not result in the intended function of the ai system being affected in a way that risks health , safety or fundamental rights.


### 3. high-risk ai systems shall be resilient as regards 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. ### 3. sufficient and technically feasible measures shall be taken to ensure that high-risk ai systems shall be resilient as regards 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.


### 1. users of high-risk ai systems shall use such systems in accordance with the instructions of use accompanying the systems , pursuant to paragraphs 2 and 5. ### 1. users of high-risk ai systems shall use such systems and implement human oversight in accordance with the instructions of use accompanying the systems , pursuant to paragraphs 2 and 5 of this article. users shall bear sole responsibility in case of any use of the ai system that is not in accordance with the instructions of use accompanying the systems.


### 1. each member state shall designate or establish a 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. ### 1. each member state shall designate or establish a 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. these procedures shall be developed in cooperation between the notifying authorities of all member states and shall result in standard procedures implemented equally in all member states , with a view to removing administrative barriers and ensuring a seamless single market.


### 8. notifying authorities shall make sure that conformity assessments are carried out in a proportionate manner , avoiding unnecessary burdens for providers and that notified bodies perform their activities taking due account of the size of an undertaking , the sector in which it operates , its structure and the degree of complexity of the ai system in question. ### 8. notifying authorities shall make sure that conformity assessments are carried out in a proportionate manner , avoiding unnecessary burdens for providers and that notified bodies perform their activities taking due account of the size of an undertaking , the sector in which it operates , its structure and the degree of complexity of the ai system in question. particular attention shall be paid to minimising administrative burdens and compliance costs for micro , small and medium-sized enterprises as defined in commission recommendation 2003/361/ec.


### 1. where harmonised standards referred to in article 40 do not exist or where the commission considers that the relevant harmonised standards are insufficient or that there is a need to address specific safety or fundamental right concerns , the commission may , by means of implementing acts , adopt common specifications in respect of the requirements set out in chapter 2 of this title. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 74(2). ### 1. where harmonised standards referred to in article 40 do not exist or where the commission considers that the relevant harmonised standards are significantly insufficient or that there is a need to address specific and pressing safety or fundamental right concern that cannot be sufficiently settled by development of harmonised standards , the commission may , by means of implementing acts , adopt common specifications in respect of the requirements set out in chapter 2 of this title. those implementing acts shall be adopted in accordance with the examination procedure referred to in article 74(2).


### 2. the commission , when preparing the common specifications referred to in paragraph 1 , shall gather the views of relevant bodies or expert groups established under relevant sectorial union law. ### 2. the commission , when preparing the common specifications referred to in paragraph 1 , shall gather the views of the developers and providers of high-risk ai systems and relevant bodies or expert groups established under relevant sectorial union law.


### 2. the commission , when preparing the common specifications referred to in paragraph 1 , shall gather the views of relevant bodies or expert groups established under relevant sectorial union law. ### 2. the commission , when preparing the common specifications referred to in paragraph 1 , shall gather the views of applicable stakeholders , including industry representatives , smes as well as other relevant bodies or expert groups established under relevant sectorial union law.


### 2. the commission , when preparing the common specifications referred to in paragraph 1 , shall gather the views of relevant bodies or expert groups established under relevant sectorial union law. ### 2. the commission , when preparing the common specifications referred to in paragraph1 , shall gather the views of the developers and providers of high-risk ai systems and relevant bodies or expert groups established under relevant sectorial union law.


### 1. providers shall ensure that ai systems intended to interact with natural persons are designed and developed in such a way that natural persons are informed that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. this obligation shall not apply to ai systems authorised by law to detect , prevent , investigate and prosecute criminal offences , unless those systems are available for the public to report a criminal offence. ### 1. providers shall ensure that ai systems to whose primary function is to interact with natural persons are designed and developed in such a way that natural persons are informed that they are interacting with an ai system , unless this is obvious from the circumstances and the context of use. this obligation shall not apply to ai systems authorised by law to detect , prevent , investigate and prosecute criminal offences , unless those systems are available for the public to report a criminal offence.


### 3. users of an ai system that generates or manipulates image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall disclose that the content has been artificially generated or manipulated. ### 3. users of an ai system that generates or manipulates image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall disclose that the content has been artificially generated or manipulated. users shall be able to opt out of such disclosure notifications.


### 3. users of an ai system that generates or manipulates image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall disclose that the content has been artificially generated or manipulated. ### 3. users of an ai system that generates or manipulates image , audio or video content that appreciably resembles existing persons , objects , places or other entities or events and would falsely appear to a person to be authentic or truthful (‘deep fake’) , shall disclose in an appropriate clear , repetitive and visible manner that the content has been artificially generated or manipulated.


### 1. ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor shall provide a controlled environment that facilitates the development , testing and validation of innovative ai systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. this shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox. ### 1. ai regulatory sandboxes established by one or more member states competent authorities or the european data protection supervisor shall provide a controlled environment that facilitates the development , testing and validation of innovative ai systems and secure processing of personal data for a limited time before their placement on the market or putting into service pursuant to a specific plan. this shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements of this regulation and , where relevant , other union and member states legislation supervised within the sandbox.


### 5. member states’ competent authorities that have established ai regulatory sandboxes shall coordinate their activities and cooperate within the framework of the european artificial intelligence board. they shall submit annual reports to the board and the commission on the results from the implementation of those scheme , including good practices , lessons learnt and recommendations on their setup and , where relevant , on the application of this regulation and other union legislation supervised within the sandbox. ### 5. member states’ competent authorities shall coordinate their activities with regards to ai regulatory sandboxes and cooperate within the framework of the european artificial intelligence board. they shall submit annual reports to the board and the commission on the results from the implementation of those scheme , including good practices , lessons learnt and recommendations on their setup and , where relevant , on the application of this regulation and other union legislation supervised within the sandbox.


### measures for small-scale providers and users ### measures for providers and users that are sme’s or start-ups


### provide small-scale providers and start-ups with priority access to the ai regulatory sandboxes to the extent that they fulfil the eligibility conditions; ### provide smes and start-ups with priority access to and make ai regulatory sandboxes reusable as well as affordable to the extent that smes and start-ups fulfil the eligibility conditions;


### organise specific awareness raising activities about the application of this regulation tailored to the needs of the small-scale providers and users; ### organise specific awareness raising and training activities about the application of this regulation tailored to the needs of sme’s and start-ups;


### where appropriate , establish a dedicated channel for communication with small-scale providers and user and other innovators to provide guidance and respond to queries about the implementation of this regulation. ### where appropriate , establish a dedicated channel for communication with sme’s and start-ups and user and other innovators to provide guidance and respond to queries about the implementation of this regulation;


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national or international authorities and relevant stakeholders , including from the private sector , shall be invited to the meetings , where the issues discussed are of relevance for them.


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority. other national authorities may also be invited to the meetings , where the issues discussed are of relevance for them.


### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them. ### 1. the board shall be composed of the national supervisory authorities , who shall be represented by the head or equivalent high-level official of that authority , and the european data protection supervisor and relevant stakeholders including smes. other national authorities may be invited to the meetings , where the issues discussed are of relevance for them.


### 3. the board shall be chaired by the commission. the commission shall convene the meetings and prepare the agenda in accordance with the tasks of the board pursuant to this regulation and with its rules of procedure. the commission shall provide administrative and analytical support for the activities of the board pursuant to this regulation. ### 3. the board shall be chaired by the commission. the board’s secretariat shall convene the meetings and prepare the agenda in accordance with the tasks of the board pursuant to this regulation and with its rules of procedure. the board’s secretariat shall also provide administrative and analytical support for the activities of the board pursuant to this regulation.


### 4. the board may invite external experts and observers to attend its meetings and may hold exchanges with interested third parties to inform its activities to an appropriate extent. to that end the commission may facilitate exchanges between the board and other union bodies , offices , agencies and advisory groups. ### 4. the board shall , where relevant , invite external experts and observers to attend its meetings and may hold exchanges with interested third parties to inform its activities to an appropriate extent. to that end the commission may facilitate exchanges between the board and other union bodies , offices , agencies and advisory groups , including high level expert group on ai.


### 4. the board may invite external experts and observers to attend its meetings and may hold exchanges with interested third parties to inform its activities to an appropriate extent. to that end the commission may facilitate exchanges between the board and other union bodies , offices , agencies and advisory groups. ### 4. the board shall regularly invite external experts , in particular from organisations representing the interests of the providers and users of ai systems , smes and start-ups , civil society organisations , representatives of affected persons , researchers , standardisation organisations , testing and experimentation facilities , to attend its meetings in order to ensure accountability and appropriate participation of external actors. the commission may facilitate exchanges between the board and other union bodies , offices , agencies and advisory groups.


### 4. member states shall ensure that national competent authorities are provided with adequate financial and human resources to fulfil their tasks under this regulation. in particular , national competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise shall include an in-depth understanding of artificial intelligence technologies , data and data computing , fundamental rights , health and safety risks and knowledge of existing standards and legal requirements. ### 4. member states shall ensure that national supervisory authority is provided with adequate financial and human resources to fulfil its tasks under this regulation. in particular , national supervisory authorities shall have a sufficient number of permanently available personnel , whose competences and expertise shall include an in-depth understanding of artificial intelligence technologies , data , data protection and data computing , cybersecurity , competition law , fundamental rights , health and safety risks as well as knowledge of existing standards and legal requirements.


### 7. national competent authorities may provide guidance and advice on the implementation of this regulation , including to small-scale providers. whenever national competent authorities intend to provide guidance and advice with regard to an ai system in areas covered by other union legislation , the competent national authorities under that union legislation shall be consulted , as appropriate. member states may also establish one central contact point for communication with operators. ### 7. national competent authorities may provide guidance and advice on the implementation of this regulation , including to small-scale providers. whenever national competent authorities intend to provide guidance and advice with regard to an ai system in areas covered by other union legislation , the competent national authorities under that union legislation shall be consulted , as appropriate. member states shall also establish one central contact point for communication with operators.


### 7. national competent authorities may provide guidance and advice on the implementation of this regulation , including to small-scale providers. whenever national competent authorities intend to provide guidance and advice with regard to an ai system in areas covered by other union legislation , the competent national authorities under that union legislation shall be consulted , as appropriate. member states may also establish one central contact point for communication with operators. ### 7. national supervisory authorities may provide guidance and advice on the implementation of this regulation , including to smes and start-ups , as long as it is not in contradiction with the board’s or the commission’s guidance and advice. whenever national supervisory authorities intend to provide guidance and advice with regard to an ai system in areas covered by other union legislation , the competent authorities under that union legislation shall be consulted , as appropriate.


### 2. the post-market monitoring system shall actively and systematically collect , document and analyse relevant data provided by users or collected through other sources on the performance of high-risk ai systems throughout their lifetime , and allow the provider to evaluate the continuous compliance of ai systems with the requirements set out in title iii , chapter 2. ### 2. in order to allow the provider to evaluate the compliance of ai systems with the requirements set out in title iii , chapter 2 throughout their lifetime , the post-market monitoring system shall actively and systematically collect , document and analyse relevant data provided by users or collected through other sources , to the extent such data are readily accessible to the provider and taking into account the limits resulting from data protection , copyright and competition law , on the performance of high-risk ai systems.


### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted full access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access. ### 1. upon reasoned request access to data and documentation in the context of their activities , the market surveillance authorities shall be granted full access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access.


### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted full access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access. ### 1. when appropriate and proportionate , market surveillance authorities may request access to data and documentation in the context of their activities. the market surveillance authorities shall only be granted , access to those training , machine-learning validation and testing datasets used by the provider that are relevant and strictly necessary for the purpose of its request , after it has been clearly demonstrated that the data and documentation provided under paragraph 1 was not sufficient to assess conformity.


### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted full access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access. ### 1. upon a reasoned request the market surveillance authorities shall be granted access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access.


### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted full access to the training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access. ### 1. access to data and documentation in the context of their activities , the market surveillance authorities shall be granted access to the relevant training , validation and testing datasets used by the provider , including through application programming interfaces (‘api’) or other appropriate technical means and tools enabling remote access.


### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request , the market surveillance authorities shall be granted access to the source code of the ai system. ### deleted


### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request , the market surveillance authorities shall be granted access to the source code of the ai system. ### 2. where necessary to assess the conformity of the high-risk uses of ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request , the market surveillance authorities shall ask for the explainability of the functioning of algorithms and criteria used by an ai system.


### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request , the market surveillance authorities shall be granted access to the source code of the ai system. ### 2. where necessary to assess the conformity of the high-risk ai system with the requirements set out in title iii , chapter 2 and upon a reasoned request , the market surveillance authorities shall be granted access to other data if no confidential business information are at risk.


### 1. where , having performed an evaluation under article 65 , the market surveillance authority of a member state finds that although an ai system is in compliance with this regulation , it presents a risk to the health or safety of persons , to the compliance with obligations under union or national law intended to protect fundamental rights or to other aspects of public interest protection , it shall require the relevant operator to take all appropriate measures to ensure that the ai system concerned , when placed on the market or put into service , no longer presents that risk , to withdraw the ai system from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe. ### 1. where , having performed an evaluation under article 65 , the market surveillance authority of a member state finds and demonstrates that although an ai system is in compliance with this regulation , it presents a risk to the health or safety of persons , to the compliance with obligations under union or national law intended to protect fundamental rights or to other aspects of public interest protection , it shall require the relevant operator to take all appropriate measures to ensure that the ai system concerned , when placed on the market or put into service , no longer presents that risk , to withdraw the ai system from the market or to recall it within a reasonable period , commensurate with the nature of the risk , as it may prescribe.


### 1. national competent authorities and notified bodies involved in the application of this regulation shall respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect , in particular: ### 1. national competent authorities , market surveillance authorities and notified bodies involved in the application of this regulation shall put effective cybersecurity , technical and organisational measures in place to ensure the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect , in particular:


### in article 5 of regulation (eu) 2018/858 the following paragraph is added: ### in article 5 of regulation (eu) 2018/858 the following paragraphs are added:


### in article 11 of regulation (eu) 2019/2144 , the following paragraph is added: ### in article 11 of regulation (eu) 2019/2144 , the following paragraphs are added:


### logic- and knowledge-based approaches , including knowledge representation , inductive (logic) programming , knowledge bases , inference and deductive engines , (symbolic) reasoning and expert systems; ### logic- and inductive (logic) programming , inference and deductive engines.


### statistical approaches , bayesian estimation , search and optimization methods. ### deleted


### ai systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons; ### deleted


### ai systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons; ### ai systems intended to be used for the ‘real-time’ and ‘post’ remote biometric identification of natural persons without their agreement , including remote biometric identification;


### ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity. ### ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity , unless these are regulated in harmonisation legislation or sectorial regulation.


### ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity. ### ai systems intended to be used as safety components in the management and operation of road traffic , digital infrastructure and the supply of water , gas , heating and electricity.


### ai systems intended to be used as safety components in the management and operation of road traffic and the supply of water , gas , heating and electricity. ### ai systems used as safety or security components in the management and operation of road traffic to the extent that they are not embedded in a vehicle;


### ai systems intended to be used for recruitment or selection of natural persons , notably for advertising vacancies , screening or filtering applications , evaluating candidates in the course of interviews or tests; ### deleted


### ai systems intended to be used for recruitment or selection of natural persons , notably for advertising vacancies , screening or filtering applications , evaluating candidates in the course of interviews or tests; ### ai systems intended to be used to make final decisions for recruitment or selection of natural persons.


### ai systems intended to be used for recruitment or selection of natural persons , notably for advertising vacancies , screening or filtering applications , evaluating candidates in the course of interviews or tests; ### ai systems intended to be used for recruitment or selection of natural persons , screening or filtering applications , evaluating candidates in the course of interviews or tests;


### ai intended to be used for making decisions on promotion and termination of work-related contractual relationships , for task allocation and for monitoring and evaluating performance and behavior of persons in such relationships. ### ai intended to be used for making decisions on promotion and termination of work-related contractual relationships , for task allocation based on individual behaviour or personal traits or characteristics and for monitoring and evaluating performance and behaviour of persons in such relationships.


### ai intended to be used for making decisions on promotion and termination of work-related contractual relationships , for task allocation and for monitoring and evaluating performance and behavior of persons in such relationships. ### deleted


### ai intended to be used for making decisions on promotion and termination of work-related contractual relationships , for task allocation and for monitoring and evaluating performance and behavior of persons in such relationships. ### ai intended to be used for making decisions on promotion and termination of work-related contractual relationships , and for monitoring and evaluating performance and behavior of persons in such relationships.


### (2) artificial intelligence systems (ai systems) can be easily deployed in multiple sectors of the economy and society , including cross border , and circulate throughout the union. certain member states have already explored the adoption of national rules to ensure that artificial intelligence is safe and is developed and used in compliance with fundamental rights obligations. differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use ai systems. a consistent and high level of protection throughout the union should therefore be ensured , while divergences hampering the free circulation of ai systems and related products and services within the internal market should be prevented , by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on article 114 of the treaty on the functioning of the european union (tfeu). to the extent that this regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of ai systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement , it is appropriate to base this regulation , in as far as those specific rules are concerned , on article 16 of the tfeu. in light of those specific rules and the recourse to article 16 tfeu , it is appropriate to consult the european data protection board. ### (2) artificial intelligence systems (ai systems) can be easily deployed in multiple sectors of the economy and society , including cross border , and circulate throughout the union. certain member states have already explored the adoption of national rules to ensure that artificial intelligence is safe and is developed and used in compliance with fundamental rights obligations. differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use ai systems. a consistent and high level of protection throughout the union should therefore be ensured , while divergences hampering the free circulation , innovation , deployment and uptake of ai systems and related products and services within the internal market should be prevented , by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on article 114 of the treaty on the functioning of the european union (tfeu). to the extent that this regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of ai systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement , it is appropriate to base this regulation , in as far as those specific rules are concerned , on article 16 of the tfeu. in light of those specific rules and the recourse to article 16 tfeu , it is appropriate to consult the european data protection board.


### (2) artificial intelligence systems (ai systems) can be easily deployed in multiple sectors of the economy and society , including cross border , and circulate throughout the union. certain member states have already explored the adoption of national rules to ensure that artificial intelligence is safe and is developed and used in compliance with fundamental rights obligations. differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use ai systems. a consistent and high level of protection throughout the union should therefore be ensured , while divergences hampering the free circulation of ai systems and related products and services within the internal market should be prevented , by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on article 114 of the treaty on the functioning of the european union (tfeu). to the extent that this regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of ai systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement , it is appropriate to base this regulation , in as far as those specific rules are concerned , on article 16 of the tfeu. in light of those specific rules and the recourse to article 16 tfeu , it is appropriate to consult the european data protection board. ### (2) artificial intelligence systems (ai systems) can be easily deployed in multiple sectors of the economy and society , including cross border , and circulate throughout the union , affecting various activities in areas such as climate change , finance , transport , agriculture , the environment , health , the public sector , internal affairs , quality of life , etc. certain member states have already explored the adoption of national rules to ensure that artificial intelligence is safe and is developed and used in compliance with fundamental rights obligations. differing national rules that are not harmonised may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use ai systems , as well as for private users and direct or indirect beneficiaries of the various ai systems. a consistent , harmonised and high level of protection throughout the union should therefore be ensured , while divergences hampering the free circulation of ai systems and related products and services within the internal market should be prevented , by laying down uniform , clear and transparent obligations for operators and guaranteeing the uniform and proportionate protection of overriding reasons of public interest and of rights of persons throughout the internal market based on article 114 of the treaty on the functioning of the european union (tfeu). to the extent that this regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of ai systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement , it is appropriate to base this regulation , in as far as those specific rules are concerned , on article 16 of the tfeu. in light of those specific rules and the recourse to article 16 tfeu , it is appropriate to consult the european data protection board.


### (3) artificial intelligence is a fast evolving family of technologies that can contribute to a wide array of economic and societal benefits across the entire spectrum of industries and social activities. by improving prediction , optimising operations and resource allocation , and personalising digital solutions available for individuals and organisations , the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes , for example in healthcare , farming , education and training , infrastructure management , energy , transport and logistics , public services , security , justice , resource and energy efficiency , and climate change mitigation and adaptation. ### (3) artificial intelligence is a fast evolving family of technologies that can contribute and is already contributing to a wide array of economic and societal benefits across the entire spectrum of industries and social activities. by establishing an accommodative framework which entails improving prediction , optimising operations and resource allocation , and personalising digital solutions available for individuals and organisations , the use of artificial intelligence can provide key competitive advantages to companies and entire industries , and support socially and environmentally beneficial outcomes , for example in healthcare , farming , education and training , media , sports , infrastructure management , energy , transport and logistics , public services , security , justice , resource and energy efficiency , and climate change mitigation and adaptation.


### (3) artificial intelligence is a fast evolving family of technologies that can contribute to a wide array of economic and societal benefits across the entire spectrum of industries and social activities. by improving prediction , optimising operations and resource allocation , and personalising digital solutions available for individuals and organisations , the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes , for example in healthcare , farming , education and training , infrastructure management , energy , transport and logistics , public services , security , justice , resource and energy efficiency , and climate change mitigation and adaptation. ### (3) artificial intelligence is a fast evolving family of technologies that can contribute to a wide array of economic and societal benefits across the entire spectrum of industries and social activities. by improving prediction , optimising operations and resource allocation , and personalising digital solutions available for individuals and organisations , the use of artificial intelligence can provide key competitive advantages to companies and support socially and environmentally beneficial outcomes , for example in healthcare , farming , education and training , media , mobility , infrastructure management , energy , transport and logistics , public services , security , justice , resource and energy efficiency , and climate change mitigation and adaptation.


### (4) at the same time , depending on the circumstances regarding its specific application and use , artificial intelligence may generate risks and cause harm to public interests and rights that are protected by union law. such harm might be material or immaterial. ### (4) at the same time , depending on the circumstances regarding its specific application and use , artificial intelligence may generate risks and cause harm to public interests , private data and rights that are protected by union law. such harm might be material or immaterial.


### (4) at the same time , depending on the circumstances regarding its specific application and use , artificial intelligence may generate risks and cause harm to public interests and rights that are protected by union law. such harm might be material or immaterial. ### (4) at the same time , depending on the circumstances regarding its specific application and use , artificial intelligence may generate risks and cause harm to public and private interests and rights that are protected by union law. such harm might be material or immaterial.


### (8) the notion of remote biometric identification system as used in this regulation should be defined functionally , as an ai system intended for the identification of natural persons at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference database , and without prior knowledge whether the targeted person will be present and can be identified , irrespectively of the particular technology , processes or types of biometric data used. considering their different characteristics and manners in which they are used , as well as the different risks involved , a distinction should be made between ‘real-time’ and ‘post’ remote biometric identification systems. in the case of ‘real-time’ systems , the capturing of the biometric data , the comparison and the identification occur all instantaneously , near-instantaneously or in any event without a significant delay. in this regard , there should be no scope for circumventing the rules of this regulation on the ‘real-time’ use of the ai systems in question by providing for minor delays. ‘real-time’ systems involve the use of ‘live’ or ‘near-‘live’ material , such as video footage , generated by a camera or other device with similar functionality. in the case of ‘post’ systems , in contrast , the biometric data have already been captured and the comparison and identification occur only after a significant delay. this involves material , such as pictures or video footage generated by closed circuit television cameras or private devices , which has been generated before the use of the system in respect of the natural persons concerned. ### (8) the notion of biometric identification system , including remote biometric identification system as used in this regulation , should be defined functionally , as an ai system intended for the identification of natural persons including at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference data repository , excluding verification/ authentication systems whose sole purpose is to confirm that a specific natural person is the person he or she claims to be , and systems that are used to confirm the identity of a natural person for the sole purpose of having access to a service , a device or premises , and without prior knowledge whether the targeted person will be present and can be identified , irrespectively of the particular technology , processes or types of biometric data used. considering their different characteristics and manners in which they are used , as well as the different risks involved , a distinction should be made between ‘real-time’ and ‘post’ biometric identification systems. in the case of ‘real-time’ systems , the capturing of the biometric data , the comparison and the identification occur all instantaneously , near-instantaneously or in any event without a significant delay. in this regard , there should be no scope for circumventing the rules of this regulation on the ‘real-time’ use of the ai systems in question by providing for minor delays. ‘real-time’ systems involve the use of ‘live’ or ‘near-‘live’ material , such as video footage , generated by a camera or other device with similar functionality. in the case of ‘post’ systems , in contrast , the biometric data have already been captured and the comparison and identification occur only after a significant delay. this involves material , such as pictures or video footage generated by closed circuit television cameras or private devices , which has been generated before the use of the system in respect of the natural persons concerned.


### (8) the notion of remote biometric identification system as used in this regulation should be defined functionally , as an ai system intended for the identification of natural persons at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference database , and without prior knowledge whether the targeted person will be present and can be identified , irrespectively of the particular technology , processes or types of biometric data used. considering their different characteristics and manners in which they are used , as well as the different risks involved , a distinction should be made between ‘real-time’ and ‘post’ remote biometric identification systems. in the case of ‘real-time’ systems , the capturing of the biometric data , the comparison and the identification occur all instantaneously , near-instantaneously or in any event without a significant delay. in this regard , there should be no scope for circumventing the rules of this regulation on the ‘real-time’ use of the ai systems in question by providing for minor delays. ‘real-time’ systems involve the use of ‘live’ or ‘near-‘live’ material , such as video footage , generated by a camera or other device with similar functionality. in the case of ‘post’ systems , in contrast , the biometric data have already been captured and the comparison and identification occur only after a significant delay. this involves material , such as pictures or video footage generated by closed circuit television cameras or private devices , which has been generated before the use of the system in respect of the natural persons concerned. ### (8) the notion of remote biometric identification system as used in this regulation should be defined functionally , as an ai system intended for the identification of natural persons at a distance through the comparison of a person’s biometric data with the biometric data contained in a reference data repository , and without prior knowledge whether the targeted person will be present and can be identified , irrespectively of the particular technology , processes or types of biometric data used. considering their different characteristics and manners in which they are used , as well as the different risks involved , a distinction should be made between ‘real-time’ and ‘post’ remote biometric identification systems. in the case of ‘real-time’ systems , the capturing of the biometric data , the comparison and the identification occur all instantaneously , near-instantaneously or in any event without a significant delay. in this regard , there should be no scope for circumventing the rules of this regulation on the ‘real-time’ use of the ai systems in question by providing for minor delays. ‘real-time’ systems involve the use of ‘live’ or ‘near-‘live’ material , such as video footage , generated by a camera or other device with similar functionality. in the case of ‘post’ systems , in contrast , the biometric data have already been captured and the comparison and identification occur only after a significant delay. this involves material , such as pictures or video footage generated by closed circuit television cameras or private devices , which has been generated before the use of the system in respect of the natural persons concerned.