1.   A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.

2.   The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following steps:

3.   The risks referred to in this Article shall concern only those which may be reasonably mitigated or eliminated through the development or design of the high-risk AI system, or the provision of adequate technical information.

4.   The risk management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and possible interaction resulting from the combined application of the requirements set out in this Section, with a view to minimising risks more effectively while achieving an appropriate balance in implementing the measures to fulfil those requirements.

5.   The risk management measures referred to in paragraph 2, point (d), shall be such that the relevant residual risk associated with each hazard, as well as the overall residual risk of the high-risk AI systems is judged to be acceptable.

In identifying the most appropriate risk management measures, the following shall be ensured:

With a view to eliminating or reducing risks related to the use of the high-risk AI system, due consideration shall be given to the technical knowledge, experience, education, the training to be expected by the deployer, and the presumable context in which the system is intended to be used.

6.   High-risk AI systems shall be tested for the purpose of identifying the most appropriate and targeted risk management measures. Testing shall ensure that high-risk AI systems perform consistently for their intended purpose and that they are in compliance with the requirements set out in this Section.

7.   Testing procedures may include testing in real-world conditions in accordance with Article 60.

8.   The testing of high-risk AI systems shall be performed, as appropriate, at any time throughout the development process, and, in any event, prior to their being placed on the market or put into service. Testing shall be carried out against prior defined metrics and probabilistic thresholds that are appropriate to the intended purpose of the high-risk AI system.

9.   When implementing the risk management system as provided for in paragraphs 1 to 7, providers shall give consideration to whether in view of its intended purpose the high-risk AI system is likely to have an adverse impact on persons under the age of 18 and, as appropriate, other vulnerable groups.

10.   For providers of high-risk AI systems that are subject to requirements regarding internal risk management processes under other relevant provisions of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or combined with, the risk management procedures established pursuant to that law.

1.   The technical documentation of a high-risk AI system shall be drawn up before that system is placed on the market or put into service and shall be kept up-to date.

The technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV. SMEs, including start-ups, may provide the elements of the technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall establish a simplified technical documentation form targeted at the needs of small and microenterprises. Where an SME, including a start-up, opts to provide the information required in Annex IV in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept the form for the purposes of the conformity assessment.

2.   Where a high-risk AI system related to a product covered by the Union harmonisation legislation listed in Section A of Annex I is placed on the market or put into service, a single set of technical documentation shall be drawn up containing all the information set out in paragraph 1, as well as the information required under those legal acts.

3.   The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annex IV, where necessary, to ensure that, in light of technical progress, the technical documentation provides all the information necessary to assess the compliance of the system with the requirements set out in this Section.

1.   Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at least the following aspects:

2.   The implementation of the aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s organisation. Providers shall, in any event, respect the degree of rigour and the level of protection required to ensure the compliance of their high-risk AI systems with this Regulation.

3.   Providers of high-risk AI systems that are subject to obligations regarding quality management systems or an equivalent function under relevant sectoral Union law may include the aspects listed in paragraph 1 as part of the quality management systems pursuant to that law.

4.   For providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law, the obligation to put in place a quality management system, with the exception of paragraph 1, points (g), (h) and (i) of this Article, shall be deemed to be fulfilled by complying with the rules on internal governance arrangements or processes pursuant to the relevant Union financial services law. To that end, any harmonised standards referred to in Article 40 shall be taken into account.

1.   Before placing a high-risk AI system on the market, importers shall ensure that the system is in conformity with this Regulation by verifying that:

2.   Where an importer has sufficient reason to consider that a high-risk AI system is not in conformity with this Regulation, or is falsified, or accompanied by falsified documentation, it shall not place the system on the market until it has been brought into conformity. Where the high-risk AI system presents a risk within the meaning of Article 79(1), the importer shall inform the provider of the system, the authorised representative and the market surveillance authorities to that effect.

3.   Importers shall indicate their name, registered trade name or registered trade mark, and the address at which they can be contacted on the high-risk AI system and on its packaging or its accompanying documentation, where applicable.

4.   Importers shall ensure that, while a high-risk AI system is under their responsibility, storage or transport conditions, where applicable, do not jeopardise its compliance with the requirements set out in Section 2.

5.   Importers shall keep, for a period of 10 years after the high-risk AI system has been placed on the market or put into service, a copy of the certificate issued by the notified body, where applicable, of the instructions for use, and of the EU declaration of conformity referred to in Article 47.

6.   Importers shall provide the relevant competent authorities, upon a reasoned request, with all the necessary information and documentation, including that referred to in paragraph 5, to demonstrate the conformity of a high-risk AI system with the requirements set out in Section 2 in a language which can be easily understood by them. For this purpose, they shall also ensure that the technical documentation can be made available to those authorities.

7.   Importers shall cooperate with the relevant competent authorities in any action those authorities take in relation to a high-risk AI system placed on the market by the importers, in particular to reduce and mitigate the risks posed by it.

1.   Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems intended to be used in the area listed in point 2 of Annex III, deployers that are bodies governed by public law, or are private entities providing public services, and deployers of high-risk AI systems referred to in points 5 (b) and (c) of Annex III, shall perform an assessment of the impact on fundamental rights that the use of such system may produce. For that purpose, deployers shall perform an assessment consisting of:

2.   The obligation laid down in paragraph 1 applies to the first use of the high-risk AI system. The deployer may, in similar cases, rely on previously conducted fundamental rights impact assessments or existing impact assessments carried out by provider. If, during the use of the high-risk AI system, the deployer considers that any of the elements listed in paragraph 1 has changed or is no longer up to date, the deployer shall take the necessary steps to update the information.

3.   Once the assessment referred to in paragraph 1 of this Article has been performed, the deployer shall notify the market surveillance authority of its results, submitting the filled-out template referred to in paragraph 5 of this Article as part of the notification. In the case referred to in Article 46(1), deployers may be exempt from that obligation to notify.

4.   If any of the obligations laid down in this Article is already met through the data protection impact assessment conducted pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680, the fundamental rights impact assessment referred to in paragraph 1 of this Article shall complement that data protection impact assessment.

5.   The AI Office shall develop a template for a questionnaire, including through an automated tool, to facilitate deployers in complying with their obligations under this Article in a simplified manner.

1.   In addition to the obligations listed in Articles 53 and 54, providers of general-purpose AI models with systemic risk shall:

2.   Providers of general-purpose AI models with systemic risk may rely on codes of practice within the meaning of Article 56 to demonstrate compliance with the obligations set out in paragraph 1 of this Article, until a harmonised standard is published. Compliance with European harmonised standards grants providers the presumption of conformity to the extent that those standards cover those obligations. Providers of general-purpose AI models with systemic risks who do not adhere to an approved code of practice or do not comply with a European harmonised standard shall demonstrate alternative adequate means of compliance for assessment by the Commission.

3.   Any information or documentation obtained pursuant to this Article, including trade secrets, shall be treated in accordance with the confidentiality obligations set out in Article 78.

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:

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 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.