dministrative requirements for application, selection, participation and exiting the AI
regulatory sandbox are simple, easily intelligible, and clearly communicated in order to facilitate the participation of
SMEs, including start-ups, with limited legal and administrative capacities and are streamlined across the Union, in order
to avoid fragmentation and that participation in an AI regulatory sandbox established by a Member State, or by the
European Data Protection Supervisor is mutually and uniformly recognised and carries the same legal effects across the
Union;
(h) that participation in the AI regulatory sandbox is limited to a period that is appropriate to the complexity and scale of
the project and that may be extended by the national competent authority;
(i) that AI regulatory sandboxes facilitate the development of tools and infrastructure for testing, benchmarking, assessing
and explaining dimensions of AI systems relevant for regulatory learning, such as accuracy, robustness and
cybersecurity, as well as measures to mitigate risks to fundamental rights and society at large.
3. Prospective providers in the AI regulatory sandboxes, in particular SMEs and start-ups, shall be directed, where
relevant, to pre-deployment services such as guidance on the implementation of this Regulation, to other value-adding
services such as help with standardisation documents and certification, testing and experimentation facilities, European
Digital Innovation Hubs and centres of exce


s Regulation, to other value-adding
services such as help with standardisation documents and certification, testing and experimentation facilities, European
Digital Innovation Hubs and centres of excellence.
4. Where national competent authorities consider authorising testing in real world conditions supervised within the
framework of an AI regulatory sandbox to be established under this Article, they shall specifically agree the terms and
conditions of such testing and, in particular, the appropriate safeguards with the participants, with a view to protecting
fundamental rights, health and safety. Where appropriate, they shall cooperate with other national competent authorities
with a view to ensuring consistent practices across the Union.

Article 58 - Detailed arrangements for, and functioning of, AI regulatory sandboxes


Article 59 - Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory

sandbox
1. In the AI regulatory sandbox, personal data lawfully collected for other purposes may be processed solely for the
purpose of developing, training and testing certain AI systems in the sandbox when all of the following conditions are met:
(a) AI systems shall be developed for safeguarding substantial public interest by a public authority or another natural or
legal person and in one or more of the following areas:
(i) public safety and public health, including disease detection, diagnosis prevention, control and treatment and
improvement of health care systems;
(ii) a high level of protection and improvement of the quality of the environment, protection of biodiversity, protection
against pollution, green transition measures, climate change mitigation and adaptation measures;
(iii) energy sustainability;
(iv) safety and resilience of transport systems and mobility, critical infrastructure and networks;
(v) efficiency and quality of public administration and public services;
(b) the data processed are necessary for complying with one or more of the requirements referred to in Chapter III,
Section 2 where those requirements cannot effectively be fulfilled by processing anonymised, synthetic or other
non-personal data;
(c) there are effective monitoring mechanisms to identify if any high risks to the rights and freedoms of the data subjects, as
referred to in Article 35 of Regulation (EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise
during the san


ify if any high risks to the rights and freedoms of the data subjects, as
referred to in Article 35 of Regulation (EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise
during the sandbox experimentation, as well as response mechanisms to promptly mitigate those risks and, where
necessary, stop the processing;
(d) any personal data to be processed in the context of the sandbox are in a functionally separate, isolated and protected
data processing environment under the control of the prospective provider and only authorised persons have access to
those data;
(e) providers can further share the originally collected data only in accordance with Union data protection law; any
personal data created in the sandbox cannot be shared outside the sandbox;
(f) any processing of personal data in the context of the sandbox neither leads to measures or decisions affecting the data
subjects nor does it affect the application of their rights laid down in Union law on the protection of personal data;
(g) any personal data processed in the context of the sandbox are protected by means of appropriate technical and
organisational measures and deleted once the participation in the sandbox has terminated or the personal data has
reached the end of its retention period;
(h) the logs of the processing of personal data in the context of the sandbox are kept for the duration of the participation in
the sandbox, unless provided otherwise by Union or national law;
(i) a complete and det


the processing of personal data in the context of the sandbox are kept for the duration of the participation in
the sandbox, unless provided otherwise by Union or national law;
(i) a complete and detailed description of the process and rationale behind the training, testing and validation of the AI
system is kept together with the testing results as part of the technical documentation referred to in Annex IV;
(j) a short summary of the AI project developed in the sandbox, its objectives and expected results is published on the
website of the competent authorities; this obligation shall not cover sensitive operational data in relation to the activities
of law enforcement, border control, immigration or asylum authorities.
2. For the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of
criminal penalties, including safeguarding against and preventing threats to public security, under the control and
responsibility of law enforcement authorities, the processing of personal data in AI regulatory sandboxes shall be based on
a specific Union or national law and subject to the same cumulative conditions as referred to in paragraph 1.
3. Paragraph 1 is without prejudice to Union or national law which excludes processing of personal data for other
purposes than those explicitly mentioned in that law, as well as to Union or national law laying down the basis for the
processing of personal data which is necessary for the purpose o


data for other
purposes than those explicitly mentioned in that law, as well as to Union or national law laying down the basis for the
processing of personal data which is necessary for the purpose of developing, testing or training of innovative AI systems or
any other legal basis, in compliance with Union law on the protection of personal data.


Article 60 - Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

1. Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by
providers or prospective providers of high-risk AI systems listed in Annex III, in accordance with this Article and the
real-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5.
The Commission shall, by means of implementing acts, specify the detailed elements of the real-world testing plan. Those
implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
This paragraph shall be without prejudice to Union or national law on the testing in real world conditions of high-risk AI
systems related to products covered by Union harmonisation legislation listed in Annex I.
2. Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III in real world
conditions at any time before the placing on the market or the putting into service of the AI system on their own or in
partnership with one or more deployers or prospective deployers.
3. The testing of high-risk AI systems in real world conditions under this Article shall be without prejudice to any ethical
review that is required by Union or national law.
4. Providers or prospective providers may conduct the testing in real world conditions only where all of the following
conditions are met:
(a) the provider or prospective provider has drawn up a real-world testing plan and submitted it


rs may conduct the testing in real world conditions only where all of the following
conditions are met:
(a) the provider or prospective provider has drawn up a real-world testing plan and submitted it to the market surveillance
authority in the Member State where the testing in real world conditions is to be conducted;
(b) the market surveillance authority in the Member State where the testing in real world conditions is to be conducted has
approved the testing in real world conditions and the real-world testing plan; where the market surveillance authority
has not provided an answer within 30 days, the testing in real world conditions and the real-world testing plan shall be
understood to have been approved; where national law does not provide for a tacit approval, the testing in real world
conditions shall remain subject to an authorisation;
(c) the provider or prospective provider, with the exception of providers or prospective providers of high-risk AI systems
referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control
management, and high-risk AI systems referred to in point 2 of Annex III has registered the testing in real world
conditions in accordance with Article 71(4) with a Union-wide unique single identification number and with the
information specified in Annex IX; the provider or prospective provider of high-risk AI systems referred to in points 1,
6 and 7 of Annex III in the areas of law enforcement, migra


number and with the
information specified in Annex IX; the provider or prospective provider of high-risk AI systems referred to in points 1,
6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, has registered
the testing in real-world conditions in the secure non-public section of the EU database according to Article 49(4), point
(d), with a Union-wide unique single identification number and with the information specified therein; the provider or
prospective provider of high-risk AI systems referred to in point 2 of Annex III has registered the testing in real-world
conditions in accordance with Article 49(5);
(d) the provider or prospective provider conducting the testing in real world conditions is established in the Union or has
appointed a legal representative who is established in the Union;
(e) data collected and processed for the purpose of the testing in real world conditions shall be transferred to third
countries only provided that appropriate and applicable safeguards under Union law are implemented;
(f) the testing in real world conditions does not last longer than necessary to achieve its objectives and in any case not
longer than six months, which may be extended for an additional period of six months, subject to prior notification by
the provider or prospective provider to the market surveillance authority, accompanied by an explanation of the need
for such an extension;
(g) the subjects of the testing in real w


or notification by
the provider or prospective provider to the market surveillance authority, accompanied by an explanation of the need
for such an extension;
(g) the subjects of the testing in real world conditions who are persons belonging to vulnerable groups due to their age or
disability, are appropriately protected;
(h) where a provider or prospective provider organises the testing in real world conditions in cooperation with one or more
deployers or prospective deployers, the latter have been informed of all aspects of the testing that are relevant to their
decision to participate, and given the relevant instructions for use of the AI system referred to in Article 13; the
provider or prospective provider and the deployer or prospective deployer shall conclude an agreement specifying their
roles and responsibilities with a view to ensuring compliance with the provisions for testing in real world conditions
under this Regulation and under other applicable Union and national law;
(i) the subjects of the testing in real world conditions have given informed consent in accordance with Article 61, or in the
case of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the
testing itself and the outcome of the testing in the real world conditions shall not have any negative effect on the
subjects, and their personal data shall be deleted after the test is performed;
(j) the testing in real world conditions is effectively overseen


ld conditions shall not have any negative effect on the
subjects, and their personal data shall be deleted after the test is performed;
(j) the testing in real world conditions is effectively overseen by the provider or prospective provider, as well as by
deployers or prospective deployers through persons who are suitably qualified in the relevant field and have the
necessary capacity, training and authority to perform their tasks;
(k) the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded.
5. Any subjects of the testing in real world conditions, or their legally designated representative, as appropriate, may,
without any resulting detriment and without having to provide any justification, withdraw from the testing at any time by
revoking their informed consent and may request the immediate and permanent deletion of their personal data. The
withdrawal of the informed consent shall not affect the activities already carried out.
6. In accordance with Article 75, Member States shall confer on their market surveillance authorities the powers of
requiring providers and prospective providers to provide information, of carrying out unannounced remote or on-site
inspections, and of performing checks on the conduct of the testing in real world conditions and the related high-risk AI
systems. Market surveillance authorities shall use those powers to ensure the safe development of testing in real world
conditions.
7. Any serious incide


world conditions and the related high-risk AI
systems. Market surveillance authorities shall use those powers to ensure the safe development of testing in real world
conditions.
7. Any serious incident identified in the course of the testing in real world conditions shall be reported to the national
market surveillance authority in accordance with Article 73. The provider or prospective provider shall adopt immediate
mitigation measures or, failing that, shall suspend the testing in real world conditions until such mitigation takes place, or
otherwise terminate it. The provider or prospective provider shall establish a procedure for the prompt recall of the AI
system upon such termination of the testing in real world conditions.
8. Providers or prospective providers shall notify the national market surveillance authority in the Member State where
the testing in real world conditions is to be conducted of the suspension or termination of the testing in real world
conditions and of the final outcomes.
9. The provider or prospective provider shall be liable under applicable Union and national liability law for any damage
caused in the course of their testing in real world conditions.


Article 61 - Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

1. For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained
from the subjects of testing prior to their participation in such testing and after their having been duly informed with
concise, clear, relevant, and understandable information regarding:
(a) the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to
their participation;
(b) the conditions under which the testing in real world conditions is to be conducted, including the expected duration of
the subject or subjects’ participation;
(c) their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the
right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having
to provide any justification;
(d) the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of
the AI system;
(e) the Union-wide unique single identification number of the testing in real world conditions in accordance with Article
60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be
obtained.
2. The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal
representative.


Article 62 - Measures for providers and deployers, in particular SMEs, including start-ups

1. Member States shall undertake the following actions:
(a) provide SMEs, including start-ups, having a registered office or a branch in the Union, with priority access to the AI
regulatory sandboxes, to the extent that they fulfil the eligibility conditions and selection criteria; the priority access
shall not preclude other SMEs, including start-ups, other than those referred to in this paragraph from access to the AI
regulatory sandbox, provided that they also fulfil the eligibility conditions and selection criteria;
(b) organise specific awareness raising and training activities on the application of this Regulation tailored to the needs of
SMEs including start-ups, deployers and, as appropriate, local public authorities;
(c) utilise existing dedicated channels and where appropriate, establish new ones for communication with SMEs including
start-ups, deployers, other innovators and, as appropriate, local public authorities to provide advice and respond to
queries about the implementation of this Regulation, including as regards participation in AI regulatory sandboxes;
(d) facilitate the participation of SMEs and other relevant stakeholders in the standardisation development process.
2. The specific interests and needs of the SME providers, including start-ups, shall be taken into account when setting the
fees for conformity assessment under Article 43, reducing those fees proportionately to their size, market size and other
relevant indicators.
3. The AI Office shall und


into account when setting the
fees for conformity assessment under Article 43, reducing those fees proportionately to their size, market size and other
relevant indicators.
3. The AI Office shall undertake the following actions:
(a) provide standardised templates for areas covered by this Regulation, as specified by the Board in its request;
(b) develop and maintain a single information platform providing easy to use information in relation to this Regulation for
all operators across the Union;
(c) organise appropriate communication campaigns to raise awareness about the obligations arising from this Regulation;
(d) evaluate and promote the convergence of best practices in public procurement procedures in relation to AI systems.


Article 63 - Derogations for specific operators

1. Microenterprises within the meaning of Recommendation 2003/361/EC may comply with certain elements of the
quality management system required by Article 17 of this Regulation in a simplified manner, provided that they do not
have partner enterprises or linked enterprises within the meaning of that Recommendation. For that purpose, the
Commission shall develop guidelines on the elements of the quality management system which may be complied with in
a simplified manner considering the needs of microenterprises, without affecting the level of protection or the need for
compliance with the requirements in respect of high-risk AI systems.
2. Paragraph 1 of this Article shall not be interpreted as exempting those operators from fulfilling any other
requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15,
72 and 73.


Article 64 - AI Office

1. The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office.
2. Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.

Article 64 - AI Office


Article 65 - Establishment and structure of the European Artificial Intelligence Board

1. A European Artificial Intelligence Board (the ‘Board’) is hereby established.
2. The Board shall be composed of one representative per Member State. The European Data Protection Supervisor shall
participate as observer. The AI Office shall also attend the Board’s meetings, without taking part in the votes. Other national
and Union authorities, bodies or experts may be invited to the meetings by the Board on a case by case basis, where the
issues discussed are of relevance for them.
3. Each representative shall be designated by their Member State for a period of three years, renewable once.
4. Member States shall ensure that their representatives on the Board:
(a) have the relevant competences and powers in their Member State so as to contribute actively to the achievement of the
Board’s tasks referred to in Article 66;
(b) are designated as a single contact point vis-à-vis the Board and, where appropriate, taking into account Member States’
needs, as a single contact point for stakeholders;
(c) are empowered to facilitate consistency and coordination between national competent authorities in their Member State
as regards the implementation of this Regulation, including through the collection of relevant data and information for
the purpose of fulfilling their tasks on the Board.
5. The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds
majority. The rules of procedure shall, in particular, lay down procedures for the


d.
5. The designated representatives of the Member States shall adopt the Board’s rules of procedure by a two-thirds
majority. The rules of procedure shall, in particular, lay down procedures for the selection process, the duration of the
mandate of, and specifications of the tasks of, the Chair, detailed arrangements for voting, and the organisation of the
Board’s activities and those of its sub-groups.
6. The Board shall establish two standing sub-groups to provide a platform for cooperation and exchange among market
surveillance authorities and notifying authorities about issues related to market surveillance and notified bodies respectively.
The standing sub-group for market surveillance should act as the administrative cooperation group (ADCO) for this
Regulation within the meaning of Article 30 of Regulation (EU) 2019/1020.
The Board may establish other standing or temporary sub-groups as appropriate for the purpose of examining specific
issues. Where appropriate, representatives of the advisory forum referred to in Article 67 may be invited to such sub-groups
or to specific meetings of those subgroups as observers.
7. The Board shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.
8. The Board shall be chaired by one of the representatives of the Member States. The AI Office shall provide the
secretariat for the Board, convene the meetings upon request of the Chair, and prepare the agenda in accordance with the
tasks of


representatives of the Member States. The AI Office shall provide the
secretariat for the Board, convene the meetings upon request of the Chair, and prepare the agenda in accordance with the
tasks of the Board pursuant to this Regulation and its rules of procedure.


Article 66 - Tasks of the Board

The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective
application of this Regulation. To that end, the Board may in particular:
(a) contribute to the coordination among national competent authorities responsible for the application of this Regulation
and, in cooperation with and subject to the agreement of the market surveillance authorities concerned, support joint
activities of market surveillance authorities referred to in Article 74(11);
(b) collect and share technical and regulatory expertise and best practices among Member States;
(c) provide advice on the implementation of this Regulation, in particular as regards the enforcement of rules on
general-purpose AI models;
(d) contribute to the harmonisation of administrative practices in the Member States, including in relation to the
derogation from the conformity assessment procedures referred to in Article 46, the functioning of AI regulatory
sandboxes, and testing in real world conditions referred to in Articles 57, 59 and 60;
(e) at the request of the Commission or on its own initiative, issue recommendations and written opinions on any relevant
matters related to the implementation of this Regulation and to its consistent and effective application, including:
(i) on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well
as of the Commission’s guidelines;
(ii) the evaluation and review of this R

Article 66 - Tasks of the Board


uding:
(i) on the development and application of codes of conduct and codes of practice pursuant to this Regulation, as well
as of the Commission’s guidelines;
(ii) the evaluation and review of this Regulation pursuant to Article 112, including as regards the serious incident
reports referred to in Article 73, and the functioning of the EU database referred to in Article 71, the preparation
of the delegated or implementing acts, and as regards possible alignments of this Regulation with the Union
harmonisation legislation listed in Annex I;
(iii) on technical specifications or existing standards regarding the requirements set out in Chapter III, Section 2;
(iv) on the use of harmonised standards or common specifications referred to in Articles 40 and 41;
(v) trends, such as European global competitiveness in AI, the uptake of AI in the Union, and the development of
digital skills;
(vi) trends on the evolving typology of AI value chains, in particular on the resulting implications in terms of
accountability;
(vii) on the potential need for amendment to Annex III in accordance with Article 7, and on the potential need for
possible revision of Article 5 pursuant to Article 112, taking into account relevant available evidence and the
latest developments in technology;
(f) support the Commission in promoting AI literacy, public awareness and understanding of the benefits, risks,
safeguards and rights and obligations in relation to the use of AI systems;
(g) facilitate the developm

Article 66 - Tasks of the Board


Commission in promoting AI literacy, public awareness and understanding of the benefits, risks,
safeguards and rights and obligations in relation to the use of AI systems;
(g) facilitate the development of common criteria and a shared understanding among market operators and competent
authorities of the relevant concepts provided for in this Regulation, including by contributing to the development of
benchmarks;
(h) cooperate, as appropriate, with other Union institutions, bodies, offices and agencies, as well as relevant Union expert
groups and networks, in particular in the fields of product safety, cybersecurity, competition, digital and media services,
financial services, consumer protection, data and fundamental rights protection;
(i) contribute to effective cooperation with the competent authorities of third countries and with international
organisations;
(j) assist national competent authorities and the Commission in developing the organisational and technical expertise
required for the implementation of this Regulation, including by contributing to the assessment of training needs for
staff of Member States involved in implementing this Regulation;
(k) assist the AI Office in supporting national competent authorities in the establishment and development of AI
regulatory sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes;
(l) contribute to, and provide relevant advice on, the development of guidance documents;
(m) advise the Co

Article 66 - Tasks of the Board


sandboxes, and facilitate cooperation and information-sharing among AI regulatory sandboxes;
(l) contribute to, and provide relevant advice on, the development of guidance documents;
(m) advise the Commission in relation to international matters on AI;
(n) provide opinions to the Commission on the qualified alerts regarding general-purpose AI models;
(o) receive opinions by the Member States on qualified alerts regarding general-purpose AI models, and on national
experiences and practices on the monitoring and enforcement of AI systems, in particular systems integrating the
general-purpose AI models.

Article 66 - Tasks of the Board


Article 67 - Advisory forum

1. An advisory forum shall be established to provide technical expertise and advise the Board and the Commission, and
to contribute to their tasks under this Regulation.
2. The membership of the advisory forum shall represent a balanced selection of stakeholders, including industry,
start-ups, SMEs, civil society and academia. The membership of the advisory forum shall be balanced with regard to
commercial and non-commercial interests and, within the category of commercial interests, with regard to SMEs and other
undertakings.
3. The Commission shall appoint the members of the advisory forum, in accordance with the criteria set out in
paragraph 2, from amongst stakeholders with recognised expertise in the field of AI.
4. The term of office of the members of the advisory forum shall be two years, which may be extended by up to no more
than four years.
5. The Fundamental Rights Agency, ENISA, the European Committee for Standardization (CEN), the European
Committee for Electrotechnical Standardization (CENELEC), and the European Telecommunications Standards Institute
(ETSI) shall be permanent members of the advisory forum.
6. The advisory forum shall draw up its rules of procedure. It shall elect two co-chairs from among its members, in
accordance with criteria set out in paragraph 2. The term of office of the co-chairs shall be two years, renewable once.
7. The advisory forum shall hold meetings at least twice a year. The advisory forum may invite experts and other
stakeholders

Article 67 - Advisory forum


2. The term of office of the co-chairs shall be two years, renewable once.
7. The advisory forum shall hold meetings at least twice a year. The advisory forum may invite experts and other
stakeholders to its meetings.
8. The advisory forum may prepare opinions, recommendations and written contributions at the request of the Board or
the Commission.
9. The advisory forum may establish standing or temporary sub-groups as appropriate for the purpose of examining
specific questions related to the objectives of this Regulation.
10. The advisory forum shall prepare an annual report on its activities. That report shall be made publicly available.

Article 67 - Advisory forum


Article 68 - Scientific panel of independent experts

1. The Commission shall, by means of an implementing act, make provisions on the establishment of a scientific panel
of independent experts (the ‘scientific panel’) intended to support the enforcement activities under this Regulation. That
implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
2. The scientific panel shall consist of experts selected by the Commission on the basis of up-to-date scientific or
technical expertise in the field of AI necessary for the tasks set out in paragraph 3, and shall be able to demonstrate meeting
all of the following conditions:
(a) having particular expertise and competence and scientific or technical expertise in the field of AI;
(b) independence from any provider of AI systems or general-purpose AI models;
(c) an ability to carry out activities diligently, accurately and objectively.
The Commission, in consultation with the Board, shall determine the number of experts on the panel in accordance with
the required needs and shall ensure fair gender and geographical representation.
3. The scientific panel shall advise and support the AI Office, in particular with regard to the following tasks:
(a) supporting the implementation and enforcement of this Regulation as regards general-purpose AI models and systems,
in particular by:
(i) alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with
Article 90;
(ii) contributing to the devel


I models and systems,
in particular by:
(i) alerting the AI Office of possible systemic risks at Union level of general-purpose AI models, in accordance with
Article 90;
(ii) contributing to the development of tools and methodologies for evaluating capabilities of general-purpose AI
models and systems, including through benchmarks;
(iii) providing advice on the classification of general-purpose AI models with systemic risk;
(iv) providing advice on the classification of various general-purpose AI models and systems;
(v) contributing to the development of tools and templates;
(b) supporting the work of market surveillance authorities, at their request;
(c) supporting cross-border market surveillance activities as referred to in Article 74(11), without prejudice to the powers
of market surveillance authorities;
(d) supporting the AI Office in carrying out its duties in the context of the Union safeguard procedure pursuant to
Article 81.
4. The experts on the scientific panel shall perform their tasks with impartiality and objectivity, and shall ensure the
confidentiality of information and data obtained in carrying out their tasks and activities. They shall neither seek nor take
instructions from anyone when exercising their tasks under paragraph 3. Each expert shall draw up a declaration of
interests, which shall be made publicly available. The AI Office shall establish systems and procedures to actively manage
and prevent potential conflicts of interest.
5. The implementing a


aration of
interests, which shall be made publicly available. The AI Office shall establish systems and procedures to actively manage
and prevent potential conflicts of interest.
5. The implementing act referred to in paragraph 1 shall include provisions on the conditions, procedures and detailed
arrangements for the scientific panel and its members to issue alerts, and to request the assistance of the AI Office for the
performance of the tasks of the scientific panel.


Article 69 - Access to the pool of experts by the Member States

1. Member States may call upon experts of the scientific panel to support their enforcement activities under this
Regulation.
2. The Member States may be required to pay fees for the advice and support provided by the experts. The structure and
the level of fees as well as the scale and structure of recoverable costs shall be set out in the implementing act referred to in
Article 68(1), taking into account the objectives of the adequate implementation of this Regulation, cost-effectiveness and
the necessity of ensuring effective access to experts for all Member States.
3. The Commission shall facilitate timely access to the experts by the Member States, as needed, and ensure that the
combination of support activities carried out by Union AI testing support pursuant to Article 84 and experts pursuant to
this Article is efficiently organised and provides the best possible added value.


Article 70 - Designation of national competent authorities and single points of contact

1. Each Member State shall establish or designate as national competent authorities at least one notifying authority and
at least one market surveillance authority for the purposes of this Regulation. Those national competent authorities shall
exercise their powers independently, impartially and without bias so as to safeguard the objectivity of their activities and
tasks, and to ensure the application and implementation of this Regulation. The members of those authorities shall refrain
from any action incompatible with their duties. Provided that those principles are observed, such activities and tasks may be
performed by one or more designated authorities, in accordance with the organisational needs of the Member State.
2. Member States shall communicate to the Commission the identity of the notifying authorities and the market
surveillance authorities and the tasks of those authorities, as well as any subsequent changes thereto. Member States shall
make publicly available information on how competent authorities and single points of contact can be contacted, through
electronic communication means by 2 August 2025. Member States shall designate a market surveillance authority to act as
the single point of contact for this Regulation, and shall notify the Commission of the identity of the single point of contact.
The Commission shall make a list of the single points of contact publicly available.
3. Member States shall ensure that their national competent authorities are pro


ity of the single point of contact.
The Commission shall make a list of the single points of contact publicly available.
3. Member States shall ensure that their national competent authorities are provided with adequate technical, financial
and human resources, and with infrastructure to fulfil their tasks effectively under this Regulation. In particular, the national
competent authorities shall have a sufficient number of personnel permanently available whose competences and expertise
shall include an in-depth understanding of AI technologies, data and data computing, personal data protection,
cybersecurity, fundamental rights, health and safety risks and knowledge of existing standards and legal requirements.
Member States shall assess and, if necessary, update competence and resource requirements referred to in this paragraph on
an annual basis.
4. National competent authorities shall take appropriate measures to ensure an adequate level of cybersecurity.
5. When performing their tasks, the national competent authorities shall act in accordance with the confidentiality
obligations set out in Article 78.
6. By 2 August 2025, and once every two years thereafter, Member States shall report to the Commission on the status
of the financial and human resources of the national competent authorities, with an assessment of their adequacy. The
Commission shall transmit that information to the Board for discussion and possible recommendations.
7. The Commission shall facilitate the e


ent authorities, with an assessment of their adequacy. The
Commission shall transmit that information to the Board for discussion and possible recommendations.
7. The Commission shall facilitate the exchange of experience between national competent authorities.
8. National competent authorities may provide guidance and advice on the implementation of this Regulation, in
particular to SMEs including start-ups, taking into account the guidance and advice of the Board and the Commission, as
appropriate. Whenever national competent authorities intend to provide guidance and advice with regard to an AI system
in areas covered by other Union law, the national competent authorities under that Union law shall be consulted, as
appropriate.
9. Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data
Protection Supervisor shall act as the competent authority for their supervision.


Article 71 - EU database for high-risk AI systems listed in Annex III

1. The Commission shall, in collaboration with the Member States, set up and maintain an EU database containing
information referred to in paragraphs 2 and 3 of this Article concerning high-risk AI systems referred to in Article 6(2)
which are registered in accordance with Articles 49 and 60 and AI systems that are not considered as high-risk pursuant to
Article 6(3) and which are registered in accordance with Article 6(4) and Article 49. When setting the functional
specifications of such database, the Commission shall consult the relevant experts, and when updating the functional
specifications of such database, the Commission shall consult the Board.
2. The data listed in Sections A and B of Annex VIII shall be entered into the EU database by the provider or, where
applicable, by the authorised representative.
3. The data listed in Section C of Annex VIII shall be entered into the EU database by the deployer who is, or who acts on
behalf of, a public authority, agency or body, in accordance with Article 49(3) and (4).
4. With the exception of the section referred to in Article 49(4) and Article 60(4), point (c), the information contained in
the EU database registered in accordance with Article 49 shall be accessible and publicly available in a user-friendly manner.
The information should be easily navigable and machine-readable. The information registered in accordance with Article 60
shall be accessible only to market surveillance authorities and the Commission, unless the


ion should be easily navigable and machine-readable. The information registered in accordance with Article 60
shall be accessible only to market surveillance authorities and the Commission, unless the prospective provider or provider
has given consent for also making the information accessible the public.
5. The EU database shall contain personal data only in so far as necessary for collecting and processing information in
accordance with this Regulation. That information shall include the names and contact details of natural persons who are
responsible for registering the system and have the legal authority to represent the provider or the deployer, as applicable.
6. The Commission shall be the controller of the EU database. It shall make available to providers, prospective providers
and deployers adequate technical and administrative support. The EU database shall comply with the applicable accessibility
requirements.


Article 72 - Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems

1. Providers shall establish and document a post-market monitoring system in a manner that is proportionate to the
nature of the AI technologies and the risks of the high-risk AI system.
2. The post-market monitoring system shall actively and systematically collect, document and analyse relevant data
which may be provided by deployers or which may be collected through other sources on the performance of high-risk AI
systems throughout their lifetime, and which allow the provider to evaluate the continuous compliance of AI systems with
the requirements set out in Chapter III, Section 2. Where relevant, post-market monitoring shall include an analysis of the
interaction with other AI systems. This obligation shall not cover sensitive operational data of deployers which are
law-enforcement authorities.
3. The post-market monitoring system shall be based on a post-market monitoring plan. The post-market monitoring
plan shall be part of the technical documentation referred to in Annex IV. The Commission shall adopt an implementing act
laying down detailed provisions establishing a template for the post-market monitoring plan and the list of elements to be
included in the plan by 2 February 2026. That implementing act shall be adopted in accordance with the examination
procedure referred to in Article 98(2).
4. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where
a post-market monitoring system and plan are already establishe

POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE


ed to in Article 98(2).
4. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, where
a post-market monitoring system and plan are already established under that legislation, in order to ensure consistency,
avoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the
necessary elements described in paragraphs 1, 2 and 3 using the template referred in paragraph 3 into systems and plans
already existing under that legislation, provided that it achieves an equivalent level of protection.
The first subparagraph of this paragraph shall also apply to high-risk AI systems referred to in point 5 of Annex III placed
on the market or put into service by financial institutions that are subject to requirements under Union financial services
law regarding their internal governance, arrangements or processes.


Article 73 - Reporting of serious incidents

1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market
surveillance authorities of the Member States where that incident occurred.
2. The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link
between the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than
15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident.
The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident.
3. Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or a serious incident as
defined in Article 3, point (49)(b), the report referred to in paragraph 1 of this Article shall be provided immediately, and
not later than two days after the provider or, where applicable, the deployer becomes aware of that incident.
4. Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the
provider or the deployer has established, or as soon as it suspects, a causal relationship between the high-risk AI system and
the serious incident, but not later than 10 days after the date on which the provider or, where applicable, the deployer
becomes aware of the serious incident.
5. Where necessary to ensure timely reporting, the provider or, where applicable,


10 days after the date on which the provider or, where applicable, the deployer
becomes aware of the serious incident.
5. Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial
report that is incomplete, followed by a complete report.
6. Following the reporting of a serious incident pursuant to paragraph 1, the provider shall, without delay, perform the
necessary investigations in relation to the serious incident and the AI system concerned. This shall include a risk assessment
of the incident, and corrective action.
The provider shall cooperate with the competent authorities, and where relevant with the notified body concerned, during
the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the
AI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing
the competent authorities of such action.
7. Upon receiving a notification related to a serious incident referred to in Article 3, point (49)(c), the relevant market
surveillance authority shall inform the national public authorities or bodies referred to in Article 77(1). The Commission
shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1 of this Article. That
guidance shall be issued by 2 August 2025, and shall be assessed regularly.
8. The market surveillance authority shall take appropriate


ith the obligations set out in paragraph 1 of this Article. That
guidance shall be issued by 2 August 2025, and shall be assessed regularly.
8. The market surveillance authority shall take appropriate measures, as provided for in Article 19 of Regulation (EU)
2019/1020, within seven days from the date it received the notification referred to in paragraph 1 of this Article, and shall
follow the notification procedures as provided in that Regulation.
9. For high-risk AI systems referred to in Annex III that are placed on the market or put into service by providers that are
subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the
notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c).
10. For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulations
(EU) 2017/745 and (EU) 2017/746, the notification of serious incidents shall be limited to those referred to in Article 3,
point (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the
Member States where the incident occurred.
11. National competent authorities shall immediately notify the Commission of any serious incident, whether or not
they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.


incident, whether or not
they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.


Article 74 - Market surveillance and control of AI systems in the Union market

1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective
enforcement of this Regulation:
(a) any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators
identified in Article 2(1) of this Regulation;
(b) any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling
within the scope of this Regulation.
2. As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance
authorities shall report annually to the Commission and relevant national competition authorities any information
identified in the course of market surveillance activities that may be of potential interest for the application of Union law on
competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred
during that year and about the measures taken.
3. For high-risk AI systems related to products covered by the Union harmonisation legislation listed in Section A of
Annex I, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market
surveillance activities designated under those legal acts.
By derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another
relevant authority to act as a market surveillance authority, provided they ensure co


.
By derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another
relevant authority to act as a market surveillance authority, provided they ensure coordination with the relevant sectoral
market surveillance authorities responsible for the enforcement of the Union harmonisation legislation listed in Annex I.
4. The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to AI systems related to products
covered by the Union harmonisation legislation listed in section A of Annex I, where such legal acts already provide for
procedures ensuring an equivalent level of protection and having the same objective. In such cases, the relevant sectoral
procedures shall apply instead.
5. Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation (EU) 2019/1020,
for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the
powers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.
6. For high-risk AI systems placed on the market, put into service, or used by financial institutions regulated by Union
financial services law, the market surveillance authority for the purposes of this Regulation shall be the relevant national
authority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the
market, putting into service


Regulation shall be the relevant national
authority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the
market, putting into service, or the use of the AI system is in direct connection with the provision of those financial
services.
7. By way of derogation from paragraph 6, in appropriate circumstances, and provided that coordination is ensured,
another relevant authority may be identified by the Member State as market surveillance authority for the purposes of this
Regulation.
National market surveillance authorities supervising regulated credit institutions regulated under Directive 2013/36/EU,
which are participating in the Single Supervisory Mechanism established by Regulation (EU) No 1024/2013, should report,
without delay, to the European Central Bank any information identified in the course of their market surveillance activities
that may be of potential interest for the prudential supervisory tasks of the European Central Bank specified in that
Regulation.
8. For high-risk AI systems listed in point 1 of Annex III to this Regulation, in so far as the systems are used for law
enforcement purposes, border management and justice and democracy, and for high-risk AI systems listed in points 6, 7
and 8 of Annex III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of
this Regulation either the competent data protection supervisory authorities under Regula


x III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of
this Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive
(EU) 2016/680, or any other authority designated pursuant to the same conditions laid down in Articles 41 to 44 of
Directive (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities, or
otherwise interfere with their activities when acting in their judicial capacity.
9. Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data
Protection Supervisor shall act as their market surveillance authority, except in relation to the Court of Justice of the
European Union acting in its judicial capacity.
10. Member States shall facilitate coordination between market surveillance authorities designated under this Regulation
and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed
in Annex I, or in other Union law, that might be relevant for the high-risk AI systems referred to in Annex III.
11. Market surveillance authorities and the Commission shall be able to propose joint activities, including joint
investigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the
Commission, that have the aim of promoting compliance, identif


uding joint
investigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the
Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness or providing
guidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present
a serious risk across two or more Member States in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office
shall provide coordination support for joint investigations.
12. Without prejudice to the powers provided for under Regulation (EU) 2019/1020, and where relevant and limited to
what is necessary to fulfil their tasks, the market surveillance authorities shall be granted full access by providers to the
documentation as well as the training, validation and testing data sets used for the development of high-risk AI systems,
including, where appropriate and subject to security safeguards, through application programming interfaces (API) or other
relevant technical means and tools enabling remote access.
13. Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned
request and only when both of the following conditions are fulfilled:
(a) access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in
Chapter III, Section 2; and
(b) testing or auditing procedures and verifications


) access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in
Chapter III, Section 2; and
(b) testing or auditing procedures and verifications based on the data and documentation provided by the provider have
been exhausted or proved insufficient.
14. Any information or documentation obtained by market surveillance authorities shall be treated in accordance with
the confidentiality obligations set out in Article 78.


Article 75 - Mutual assistance, market surveillance and control of general-purpose AI systems

1. Where an AI system is based on a general-purpose AI model, and the model and the system are developed by the
same provider, the AI Office shall have powers to monitor and supervise compliance of that AI system with obligations
under this Regulation. To carry out its monitoring and supervision tasks, the AI Office shall have all the powers of a market
surveillance authority provided for in this Section and Regulation (EU) 2019/1020.
2. Where the relevant market surveillance authorities have sufficient reason to consider general-purpose AI systems that
can be used directly by deployers for at least one purpose that is classified as high-risk pursuant to this Regulation to be
non-compliant with the requirements laid down in this Regulation, they shall cooperate with the AI Office to carry out
compliance evaluations, and shall inform the Board and other market surveillance authorities accordingly.
3. Where a market surveillance authority is unable to conclude its investigation of the high-risk AI system because of its
inability to access certain information related to the general-purpose AI model despite having made all appropriate efforts
to obtain that information, it may submit a reasoned request to the AI Office, by which access to that information shall be
enforced. In that case, the AI Office shall supply to the applicant authority without delay, and in any event within 30 days,
any information that the AI Office considers to be relevant in order to establish whether a h


ase, the AI Office shall supply to the applicant authority without delay, and in any event within 30 days,
any information that the AI Office considers to be relevant in order to establish whether a high-risk AI system is
non-compliant. Market surveillance authorities shall safeguard the confidentiality of the information that they obtain in
accordance with Article 78 of this Regulation. The procedure provided for in Chapter VI of Regulation (EU) 2019/1020
shall apply mutatis mutandis.


Article 76 - Supervision of testing in real world conditions by market surveillance authorities

1. Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in
accordance with this Regulation.
2. Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory
sandbox under Article 58, the market surveillance authorities shall verify the compliance with Article 60 as part of their
supervisory role for the AI regulatory sandbox. Those authorities may, as appropriate, allow the testing in real world
conditions to be conducted by the provider or prospective provider, in derogation from the conditions set out in Article
60(4), points (f) and (g).
3. Where a market surveillance authority has been informed by the prospective provider, the provider or any third party
of a serious incident or has other grounds for considering that the conditions set out in Articles 60 and 61 are not met, it
may take either of the following decisions on its territory, as appropriate:
(a) to suspend or terminate the testing in real world conditions;
(b) to require the provider or prospective provider and the deployer or prospective deployer to modify any aspect of the
testing in real world conditions.
4. Where a market surveillance authority has taken a decision referred to in paragraph 3 of this Article, or has issued an
objection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor
and how the provider or prospective provider can c


Article, or has issued an
objection within the meaning of Article 60(4), point (b), the decision or the objection shall indicate the grounds therefor
and how the provider or prospective provider can challenge the decision or objection.
5. Where applicable, where a market surveillance authority has taken a decision referred to in paragraph 3, it shall
communicate the grounds therefor to the market surveillance authorities of other Member States in which the AI system
has been tested in accordance with the testing plan.


Article 77 - Powers of authorities protecting fundamental rights

1. National public authorities or bodies which supervise or enforce the respect of obligations under Union law
protecting fundamental rights, including the right to non-discrimination, in relation to the use of high-risk AI systems
referred to in Annex III shall have the power to request and access any documentation created or maintained under this
Regulation in accessible language and format when access to that documentation is necessary for effectively fulfilling their
mandates within the limits of their jurisdiction. The relevant public authority or body shall inform the market surveillance
authority of the Member State concerned of any such request.
2. By 2 November 2024, each Member State shall identify the public authorities or bodies referred to in paragraph 1 and
make a list of them publicly available. Member States shall notify the list to the Commission and to the other Member
States, and shall keep the list up to date.
3. Where the documentation referred to in paragraph 1 is insufficient to ascertain whether an infringement of
obligations under Union law protecting fundamental rights has occurred, the public authority or body referred to in
paragraph 1 may make a reasoned request to the market surveillance authority, to organise testing of the high-risk AI
system through technical means. The market surveillance authority shall organise the testing with the close involvement of
the requesting public authority or body within a reasonable time following the request.
4


gh technical means. The market surveillance authority shall organise the testing with the close involvement of
the requesting public authority or body within a reasonable time following the request.
4. Any information or documentation obtained by the national public authorities or bodies referred to in paragraph 1 of
this Article pursuant to this Article shall be treated in accordance with the confidentiality obligations set out in Article 78.


Article 78 - Confidentiality

1. The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved
in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of
information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular:
(a) the intellectual property rights and confidential business information or trade secrets of a natural or legal person,
including source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943 of the European
Parliament and of the Council (57);
(b) the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits;
(c) public and national security interests;
(d) the conduct of criminal or administrative proceedings;
(e) information classified pursuant to Union or national law.
2. The authorities involved in the application of this Regulation pursuant to paragraph 1 shall request only data that is
strictly necessary for the assessment of the risk posed by AI systems and for the exercise of their powers in accordance with
this Regulation and with Regulation (EU) 2019/1020. They shall put in place adequate and effective cybersecurity measures
to protect the security and confidentiality of the information and data obtained, and shall delete the data collected as soon
as it is no longer needed for the purpose for which it was obtained, in accordance with

Article 78 - Confidentiality


security and confidentiality of the information and data obtained, and shall delete the data collected as soon
as it is no longer needed for the purpose for which it was obtained, in accordance with applicable Union or national law.
3. Without prejudice to paragraphs 1 and 2, information exchanged on a confidential basis between the national
competent authorities or between national competent authorities and the Commission shall not be disclosed without prior
consultation of the originating national competent authority and the deployer when high-risk AI systems referred to in
point 1, 6 or 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities and when such
disclosure would jeopardise public and national security interests. This exchange of information shall not cover sensitive
operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities.
When the law enforcement, immigration or asylum authorities are providers of high-risk AI systems referred to in point 1,
6 or 7 of Annex III, the technical documentation referred to in Annex IV shall remain within the premises of those
authorities. Those authorities shall ensure that the market surveillance authorities referred to in Article 74(8) and (9), as
applicable, can, upon request, immediately access the documentation or obtain a copy thereof. Only staff of the market
surveillance authority holding the appropriate level of security cleara

Article 78 - Confidentiality


d (9), as
applicable, can, upon request, immediately access the documentation or obtain a copy thereof. Only staff of the market
surveillance authority holding the appropriate level of security clearance shall be allowed to access that documentation or
any copy thereof.
4. Paragraphs 1, 2 and 3 shall not affect the rights or obligations of the Commission, Member States and their relevant
authorities, as well as those of notified bodies, with regard to the exchange of information and the dissemination of
warnings, including in the context of cross-border cooperation, nor shall they affect the obligations of the parties concerned
to provide information under criminal law of the Member States.
5. The Commission and Member States may exchange, where necessary and in accordance with relevant provisions of
international and trade agreements, confidential information with regulatory authorities of third countries with which they
have concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.

Article 78 - Confidentiality


Article 79 - Procedure at national level for dealing with AI systems presenting a risk

1. AI systems presenting a risk shall be understood as a ‘product presenting a risk’ as defined in Article 3, point 19 of
Regulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights, of persons.
2. Where the market surveillance authority of a Member State has sufficient reason to consider an AI system to present
a risk as referred to in paragraph 1 of this Article, it shall carry out an evaluation of the AI system concerned in respect of
its compliance with all the requirements and obligations laid down in this Regulation. Particular attention shall be given to
AI systems presenting a risk to vulnerable groups. Where risks to fundamental rights are identified, the market surveillance
authority shall also inform and fully cooperate with the relevant national public authorities or bodies referred to in Article
77(1). The relevant operators shall cooperate as necessary with the market surveillance authority and with the other
national public authorities or bodies referred to in Article 77(1).
(57) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how
and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).
Where, in the course of that evaluation, the market surveillance authority or, where applicable the market surveillance
authority in cooperation with the national public authority referred


16, p. 1).
Where, in the course of that evaluation, the market surveillance authority or, where applicable the market surveillance
authority in cooperation with the national public authority referred to in Article 77(1), finds that the AI system does not
comply with the requirements and obligations laid down in this Regulation, it shall without undue delay require the relevant
operator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from
the market, or to recall it within a period the market surveillance authority may prescribe, and in any event within the
shorter of 15 working days, or as provided for in the relevant Union harmonisation legislation.
The market surveillance authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU)
2019/1020 shall apply to the measures referred to in the second subparagraph of this paragraph.
3. Where the market surveillance authority considers that the non-compliance is not restricted to its national territory, it
shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the
actions which it has required the operator to take.
4. The operator shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that
it has made available on the Union market.
5. Where the operator of an AI system does not take adequate corrective action within the period refer


taken in respect of all the AI systems concerned that
it has made available on the Union market.
5. Where the operator of an AI system does not take adequate corrective action within the period referred to in
paragraph 2, the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the AI
system’s being made available on its national market or put into service, to withdraw the product or the standalone AI
system from that market or to recall it. That authority shall without undue delay notify the Commission and the other
Member States of those measures.
6. The notification referred to in paragraph 5 shall include all available details, in particular the information necessary
for the identification of the non-compliant AI system, the origin of the AI system and the supply chain, the nature of the
non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments
put forward by the relevant operator. In particular, the market surveillance authorities shall indicate whether the
non-compliance is due to one or more of the following:
(a) non-compliance with the prohibition of the AI practices referred to in Article 5;
(b) a failure of a high-risk AI system to meet requirements set out in Chapter III, Section 2;
(c) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring
a presumption of conformity;
(d) non-compliance with Article


Chapter III, Section 2;
(c) shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring
a presumption of conformity;
(d) non-compliance with Article 50.
7. The market surveillance authorities other than the market surveillance authority of the Member State initiating the
procedure shall, without undue delay, inform the Commission and the other Member States of any measures adopted and of
any additional information at their disposal relating to the non-compliance of the AI system concerned, and, in the event of
disagreement with the notified national measure, of their objections.
8. Where, within three months of receipt of the notification referred to in paragraph 5 of this Article, no objection has
been raised by either a market surveillance authority of a Member State or by the Commission in respect of a provisional
measure taken by a market surveillance authority of another Member State, that measure shall be deemed justified. This
shall be without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation
(EU) 2019/1020. The three-month period referred to in this paragraph shall be reduced to 30 days in the event of
non-compliance with the prohibition of the AI practices referred to in Article 5 of this Regulation.
9. The market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the
product or the AI system concerned, such as wit


o in Article 5 of this Regulation.
9. The market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the
product or the AI system concerned, such as withdrawal of the product or the AI system from their market, without undue
delay.


Article 80 - Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III

1. Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as
non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of
the AI system concerned in respect of its classification as a high-risk AI system based on the conditions set out in Article
6(3) and the Commission guidelines.
2. Where, in the course of that evaluation, the market surveillance authority finds that the AI system concerned is
high-risk, it shall without undue delay require the relevant provider to take all necessary actions to bring the AI system into
compliance with the requirements and obligations laid down in this Regulation, as well as take appropriate corrective action
within a period the market surveillance authority may prescribe.
3. Where the market surveillance authority considers that the use of the AI system concerned is not restricted to its
national territory, it shall inform the Commission and the other Member States without undue delay of the results of the
evaluation and of the actions which it has required the provider to take.
4. The provider shall ensure that all necessary action is taken to bring the AI system into compliance with the
requirements and obligations laid down in this Regulation. Where the provider of an AI system concerned does not bring
the AI system into compliance with those requirements and obligations within the period referred to in paragrap


aid down in this Regulation. Where the provider of an AI system concerned does not bring
the AI system into compliance with those requirements and obligations within the period referred to in paragraph 2 of this
Article, the provider shall be subject to fines in accordance with Article 99.
5. The provider shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that
it has made available on the Union market.
6. Where the provider of the AI system concerned does not take adequate corrective action within the period referred to
in paragraph 2 of this Article, Article 79(5) to (9) shall apply.
7. Where, in the course of the evaluation pursuant to paragraph 1 of this Article, the market surveillance authority
establishes that the AI system was misclassified by the provider as non-high-risk in order to circumvent the application of
requirements in Chapter III, Section 2, the provider shall be subject to fines in accordance with Article 99.
8. In exercising their power to monitor the application of this Article, and in accordance with Article 11 of Regulation
(EU) 2019/1020, market surveillance authorities may perform appropriate checks, taking into account in particular
information stored in the EU database referred to in Article 71 of this Regulation.


is Regulation.


Article 81 - Union safeguard procedure

1. Where, within three months of receipt of the notification referred to in Article 79(5), or within 30 days in the case of
non-compliance with the prohibition of the AI practices referred to in Article 5, objections are raised by the market
surveillance authority of a Member State to a measure taken by another market surveillance authority, or where the
Commission considers the measure to be contrary to Union law, the Commission shall without undue delay enter into
consultation with the market surveillance authority of the relevant Member State and the operator or operators, and shall
evaluate the national measure. On the basis of the results of that evaluation, the Commission shall, within six months, or
within 60 days in the case of non-compliance with the prohibition of the AI practices referred to in Article 5, starting from
the notification referred to in Article 79(5), decide whether the national measure is justified and shall notify its decision to
the market surveillance authority of the Member State concerned. The Commission shall also inform all other market
surveillance authorities of its decision.
2. Where the Commission considers the measure taken by the relevant Member State to be justified, all Member States
shall ensure that they take appropriate restrictive measures in respect of the AI system concerned, such as requiring the
withdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. Where
the Commission c

Article 81 - Union safeguard procedure


ures in respect of the AI system concerned, such as requiring the
withdrawal of the AI system from their market without undue delay, and shall inform the Commission accordingly. Where
the Commission considers the national measure to be unjustified, the Member State concerned shall withdraw the measure
and shall inform the Commission accordingly.
3. Where the national measure is considered justified and the non-compliance of the AI system is attributed to
shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 of this Regulation,
the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

Article 81 - Union safeguard procedure


Article 82 - Compliant AI systems which present a risk

1. Where, having performed an evaluation under Article 79, after consulting the relevant national public authority
referred to in Article 77(1), the market surveillance authority of a Member State finds that although a high-risk AI system
complies with this Regulation, it nevertheless presents a risk to the health or safety of persons, to 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 without undue
delay, within a period it may prescribe.
2. The provider or other relevant operator shall ensure that corrective action is taken in respect of all the AI systems
concerned that it has made available on the Union market within the timeline prescribed by the market surveillance
authority of the Member State referred to in paragraph 1.
3. The Member States shall immediately inform the Commission and the other Member States of a finding under
paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the
AI system concerned, the origin and the supply chain of the AI system, the nature of the risk involved and the nature and
duration of the national measures taken.
4. The Commission shall without undue delay enter into consultation with the Member States concerned and the
relevant operators, and shall evaluate th


ture and
duration of the national measures taken.
4. The Commission shall without undue delay enter into consultation with the Member States concerned and the
relevant operators, and shall evaluate the national measures taken. On the basis of the results of that evaluation, the
Commission shall decide whether the measure is justified and, where necessary, propose other appropriate measures.
5. The Commission shall immediately communicate its decision to the Member States concerned and to the relevant
operators. It shall also inform the other Member States.


Article 83 - Formal non-compliance

1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the
relevant provider to put an end to the non-compliance concerned, within a period it may prescribe:
(a) the CE marking has been affixed in violation of Article 48;
(b) the CE marking has not been affixed;
(c) the EU declaration of conformity referred to in Article 47 has not been drawn up;
(d) the EU declaration of conformity referred to in Article 47 has not been drawn up correctly;
(e) the registration in the EU database referred to in Article 71 has not been carried out;
(f) where applicable, no authorised representative has been appointed;
(g) technical documentation is not available.
2. Where the non-compliance referred to in paragraph 1 persists, the market surveillance authority of the Member State
concerned shall take appropriate and proportionate measures to restrict or prohibit the high-risk AI system being made
available on the market or to ensure that it is recalled or withdrawn from the market without delay.

Article 83 - Formal non-compliance


Article 84 - Union AI testing support structures

1. The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under
Article 21(6) of Regulation (EU) 2019/1020 in the area of AI.
2. Without prejudice to the tasks referred to in paragraph 1, Union AI testing support structures shall also provide
independent technical or scientific advice at the request of the Board, the Commission, or of market surveillance authorities.


Article 85 - Right to lodge a complaint with a market surveillance authority

Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that
there has been an infringement of the provisions of this Regulation may submit complaints to the relevant market
surveillance authority.
In accordance with Regulation (EU) 2019/1020, such complaints shall be taken into account for the purpose of conducting
market surveillance activities, and shall be handled in line with the dedicated procedures established therefor by the market
surveillance authorities.


Article 86 - Right to explanation of individual decision-making

1. Any affected person subject to a decision which is taken by the deployer on the basis of the output from a high-risk AI
system listed in Annex III, with the exception of systems listed under point 2 thereof, and which produces legal effects or
similarly significantly affects that person in a way that they consider to have an adverse impact on their health, safety or
fundamental rights shall have the right to obtain from the deployer clear and meaningful explanations of the role of the AI
system in the decision-making procedure and the main elements of the decision taken.
2. Paragraph 1 shall not apply to the use of AI systems for which exceptions from, or restrictions to, the obligation
under that paragraph follow from Union or national law in compliance with Union law.
3. This Article shall apply only to the extent that the right referred to in paragraph 1 is not otherwise provided for under
Union law.


Article 87 - Reporting of infringements and protection of reporting persons

Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons
reporting such infringements.


Article 88 - Enforcement of the obligations of providers of general-purpose AI models

1. The Commission shall have exclusive powers to supervise and enforce Chapter V, taking into account the procedural
guarantees under Article 94. The Commission shall entrust the implementation of these tasks to the AI Office, without
prejudice to the powers of organisation of the Commission and the division of competences between Member States and
the Union based on the Treaties.
2. Without prejudice to Article 75(3), market surveillance authorities may request the Commission to exercise the
powers laid down in this Section, where that is necessary and proportionate to assist with the fulfilment of their tasks under
this Regulation.


Article 89 - Monitoring actions

1. For the purpose of carrying out the tasks assigned to it under this Section, the AI Office may take the necessary
actions to monitor the effective implementation and compliance with this Regulation by providers of general-purpose AI
models, including their adherence to approved codes of practice.
2. Downstream providers shall have the right to lodge a complaint alleging an infringement of this Regulation.
A complaint shall be duly reasoned and indicate at least:
(a) the point of contact of the provider of the general-purpose AI model concerned;
(b) a description of the relevant facts, the provisions of this Regulation concerned, and the reason why the downstream
provider considers that the provider of the general-purpose AI model concerned infringed this Regulation;
(c) any other information that the downstream provider that sent the request considers relevant, including, where
appropriate, information gathered on its own initiative.

Article 89 - Monitoring actions


Article 90 - Alerts of systemic risks by the scientific panel

1. The scientific panel may provide a qualified alert to the AI Office where it has reason to suspect that:
(a) a general-purpose AI model poses concrete identifiable risk at Union level; or
(b) a general-purpose AI model meets the conditions referred to in Article 51.
2. Upon such qualified alert, the Commission, through the AI Office and after having informed the Board, may exercise
the powers laid down in this Section for the purpose of assessing the matter. The AI Office shall inform the Board of any
measure according to Articles 91 to 94.
3. A qualified alert shall be duly reasoned and indicate at least:
(a) the point of contact of the provider of the general-purpose AI model with systemic risk concerned;
(b) a description of the relevant facts and the reasons for the alert by the scientific panel;
(c) any other information that the scientific panel considers to be relevant, including, where appropriate, information
gathered on its own initiative.


Article 91 - Power to request documentation and information

1. The Commission may request the provider of the general-purpose AI model concerned to provide the documentation
drawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the
purpose of assessing compliance of the provider with this Regulation.
2. Before sending the request for information, the AI Office may initiate a structured dialogue with the provider of the
general-purpose AI model.
3. Upon a duly substantiated request from the scientific panel, the Commission may issue a request for information to
a provider of a general-purpose AI model, where the access to information is necessary and proportionate for the fulfilment
of the tasks of the scientific panel under Article 68(2).
4. The request for information shall state the legal basis and the purpose of the request, specify what information is
required, set a period within which the information is to be provided, and indicate the fines provided for in Article 101 for
supplying incorrect, incomplete or misleading information.
5. The provider of the general-purpose AI model concerned, or its representative shall supply the information requested.
In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to
represent them by law or by their statutes, shall supply the information requested on behalf of the provider of the
general-purpose AI model concerned. Lawyers duly authorised to act may supply inform


represent them by law or by their statutes, shall supply the information requested on behalf of the provider of the
general-purpose AI model concerned. Lawyers duly authorised to act may supply information on behalf of their clients. The
clients shall nevertheless remain fully responsible if the information supplied is incomplete, incorrect or misleading.


Article 92 - Power to conduct evaluations

1. The AI Office, after consulting the Board, may conduct evaluations of the general-purpose AI model concerned:
(a) to assess compliance of the provider with obligations under this Regulation, where the information gathered pursuant
to Article 91 is insufficient; or
(b) to investigate systemic risks at Union level of general-purpose AI models with systemic risk, in particular following
a qualified alert from the scientific panel in accordance with Article 90(1), point (a).
2. The Commission may decide to appoint independent experts to carry out evaluations on its behalf, including from the
scientific panel established pursuant to Article 68. Independent experts appointed for this task shall meet the criteria
outlined in Article 68(2).
3. For the purposes of paragraph 1, the Commission may request access to the general-purpose AI model concerned
through APIs or further appropriate technical means and tools, including source code.
4. The request for access shall state the legal basis, the purpose and reasons of the request and set the period within
which the access is to be provided, and the fines provided for in Article 101 for failure to provide access.
5. The providers of the general-purpose AI model concerned or its representative shall supply the information requested.
In the case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to
represent them by law or by their statutes, shall provide the access requested on


case of legal persons, companies or firms, or where the provider has no legal personality, the persons authorised to
represent them by law or by their statutes, shall provide the access requested on behalf of the provider of the
general-purpose AI model concerned.
6. The Commission shall adopt implementing acts setting out the detailed arrangements and the conditions for the
evaluations, including the detailed arrangements for involving independent experts, and the procedure for the selection
thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article
98(2).
7. Prior to requesting access to the general-purpose AI model concerned, the AI Office may initiate a structured dialogue
with the provider of the general-purpose AI model to gather more information on the internal testing of the model, internal
safeguards for preventing systemic risks, and other internal procedures and measures the provider has taken to mitigate
such risks.


Article 93 - Power to request measures

1. Where necessary and appropriate, the Commission may request providers to:
(a) take appropriate measures to comply with the obligations set out in Articles 53 and 54;
(b) implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given rise to serious
and substantiated concern of a systemic risk at Union level;
(c) restrict the making available on the market, withdraw or recall the model.
2. Before a measure is requested, the AI Office may initiate a structured dialogue with the provider of the
general-purpose AI model.
3. If, during the structured dialogue referred to in paragraph 2, the provider of the general-purpose AI model with
systemic risk offers commitments to implement mitigation measures to address a systemic risk at Union level, the
Commission may, by decision, make those commitments binding and declare that there are no further grounds for action.

Article 93 - Power to request measures


Article 94 - Procedural rights of economic operators of the general-purpose AI model

Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis to the providers of the general-purpose AI model,
without prejudice to more specific procedural rights provided for in this Regulation.


Article 95 - Codes of conduct for voluntary application of specific requirements

1. The AI Office and the Member States shall encourage and facilitate the drawing up of codes of conduct, including
related governance mechanisms, intended to foster the voluntary application to AI systems, other than high-risk AI systems,
of some or all of the requirements set out in Chapter III, Section 2 taking into account the available technical solutions and
industry best practices allowing for the application of such requirements.
2. The AI Office and the Member States shall facilitate the drawing up of codes of conduct concerning the voluntary
application, including by deployers, of specific requirements to all AI systems, on the basis of clear objectives and key
performance indicators to measure the achievement of those objectives, including elements such as, but not limited to:
(a) applicable elements provided for in Union ethical guidelines for trustworthy AI;
(b) assessing and minimising the impact of AI systems on environmental sustainability, including as regards energy-efficient
programming and techniques for the efficient design, training and use of AI;
(c) promoting AI literacy, in particular that of persons dealing with the development, operation and use of AI;
(d) facilitating an inclusive and diverse design of AI systems, including through the establishment of inclusive and diverse
development teams and the promotion of stakeholders’ participation in that process;
(e) assessing and preventing the negative impact of AI systems on vulnerable persons or group


inclusive and diverse
development teams and the promotion of stakeholders’ participation in that process;
(e) assessing and preventing the negative impact of AI systems on vulnerable persons or groups of vulnerable persons,
including as regards accessibility for persons with a disability, as well as on gender equality.
3. Codes of conduct may be drawn up by individual providers or deployers of AI systems or by organisations
representing them or by both, including with the involvement of any interested stakeholders and their representative
organisations, including civil society organisations and academia. Codes of conduct may cover one or more AI systems
taking into account the similarity of the intended purpose of the relevant systems.
4. The AI Office and the Member States shall take into account the specific interests and needs of SMEs, including
start-ups, when encouraging and facilitating the drawing up of codes of conduct.


Article 96 - Guidelines from the Commission on the implementation of this Regulation

1. The Commission shall develop guidelines on the practical implementation of this Regulation, and in particular on:
(a) the application of the requirements and obligations referred to in Articles 8 to 15 and in Article 25;
(b) the prohibited practices referred to in Article 5;
(c) the practical implementation of the provisions related to substantial modification;
(d) the practical implementation of transparency obligations laid down in Article 50;
(e) detailed information on the relationship of this Regulation with the Union harmonisation legislation listed in Annex I,
as well as with other relevant Union law, including as regards consistency in their enforcement;
(f) the application of the definition of an AI system as set out in Article 3, point (1).
When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, of
local public authorities and of the sectors most likely to be affected by this Regulation.
The guidelines referred to in the first subparagraph of this paragraph shall take due account of the generally acknowledged
state of the art on AI, as well as of relevant harmonised standards and common specifications that are referred to in
Articles 40 and 41, or of those harmonised standards or technical specifications that are set out pursuant to Union
harmonisation law.
2. At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines
previously adopted when d


hat are set out pursuant to Union
harmonisation law.
2. At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines
previously adopted when deemed necessary.