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).

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 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:

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 withdrawal of the product or the AI system from their market, without undue delay.

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 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.

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 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.

1.   Where necessary and appropriate, the Commission may request providers to:

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.

1.   When placing a product with digital elements on the market, manufacturers shall ensure that it has been designed, developed and produced in accordance with the essential cybersecurity requirements set out in Part I of Annex I.

2.   For the purpose of complying with paragraph 1, manufacturers shall undertake an assessment of the cybersecurity risks associated with a product with digital elements and take the outcome of that assessment into account during the planning, design, development, production, delivery and maintenance phases of the product with digital elements with a view to minimising cybersecurity risks, preventing incidents and minimising their impact, including in relation to the health and safety of users.

3.   The cybersecurity risk assessment shall be documented and updated as appropriate during a support period to be determined in accordance with paragraph 8 of this Article. That cybersecurity risk assessment shall comprise at least an analysis of cybersecurity risks based on the intended purpose and reasonably foreseeable use, as well as the conditions of use, of the product with digital elements, such as the operational environment or the assets to be protected, taking into account the length of time the product is expected to be in use. The cybersecurity risk assessment shall indicate whether and, if so in what manner, the security requirements set out in Part I, point (2), of Annex I are applicable to the relevant product with digital elements and how those requirements are implemented as informed by the cybersecurity risk assessment. It shall also indicate how the manufacturer is to apply Part I, point (1), of Annex I and the vulnerability handling requirements set out in Part II of Annex I.

4.   When placing a product with digital elements on the market, the manufacturer shall include the cybersecurity risk assessment referred to in paragraph 3 of this Article in the technical documentation required pursuant to Article 31 and Annex VII. For products with digital elements as referred to in Article 12, which are also subject to other Union legal acts, the cybersecurity risk assessment may be part of the risk assessment required by those Union legal acts. Where certain essential cybersecurity requirements are not applicable to the product with digital elements, the manufacturer shall include a clear justification to that effect in that technical documentation.

5.   For the purpose of complying with paragraph 1, manufacturers shall exercise due diligence when integrating components sourced from third parties so that those components do not compromise the cybersecurity of the product with digital elements, including when integrating components of free and open-source software that have not been made available on the market in the course of a commercial activity.

6.   Manufacturers shall, upon identifying a vulnerability in a component, including in an open source-component, which is integrated in the product with digital elements report the vulnerability to the person or entity manufacturing or maintaining the component, and address and remediate the vulnerability in accordance with the vulnerability handling requirements set out in Part II of Annex I. Where manufacturers have developed a software or hardware modification to address the vulnerability in that component, they shall share the relevant code or documentation with the person or entity manufacturing or maintaining the component, where appropriate in a machine-readable format.

7.   The manufacturers shall systematically document, in a manner that is proportionate to the nature and the cybersecurity risks, relevant cybersecurity aspects concerning the products with digital elements, including vulnerabilities of which they become aware and any relevant information provided by third parties, and shall, where applicable, update the cybersecurity risk assessment of the products.

8.   Manufacturers shall ensure, when placing a product with digital elements on the market, and for the support period, that vulnerabilities of that product, including its components, are handled effectively and in accordance with the essential cybersecurity requirements set out in Part II of Annex I.

Manufacturers shall determine the support period so that it reflects the length of time during which the product is expected to be in use, taking into account, in particular, reasonable user expectations, the nature of the product, including its intended purpose, as well as relevant Union law determining the lifetime of products with digital elements. When determining the support period, manufacturers may also take into account the support periods of products with digital elements offering a similar functionality placed on the market by other manufacturers, the availability of the operating environment, the support periods of integrated components that provide core functions and are sourced from third parties as well as relevant guidance provided by the dedicated administrative cooperation group (ADCO) established pursuant to Article 52(15) and the Commission. The matters to be taken into account in order to determine the support period shall be considered in a manner that ensures proportionality.

Without prejudice to the second subparagraph, the support period shall be at least five years. Where the product with digital elements is expected to be in use for less than five years, the support period shall correspond to the expected use time.

Taking into account ADCO recommendations as referred to in Article 52(16), the Commission may adopt delegated acts in accordance with Article 61 to supplement this Regulation by specifying the minimum support period for specific product categories where the market surveillance data suggests inadequate support periods.

Manufacturers shall include the information that was taken into account to determine the support period of a product with digital elements in the technical documentation as set out in Annex VII.

Manufacturers shall have appropriate policies and procedures, including coordinated vulnerability disclosure policies, referred to in Part II, point (5), of Annex I to process and remediate potential vulnerabilities in the product with digital elements reported from internal or external sources.

9.   Manufacturers shall ensure that each security update, as referred to in Part II, point (8), of Annex I, which has been made available to users during the support period, remains available after it has been issued for a minimum of 10 years or for the remainder of the support period, whichever is longer.

10.   Where a manufacturer has placed subsequent substantially modified versions of a software product on the market, that manufacturer may ensure compliance with the essential cybersecurity requirement set out in Part II, point (2), of Annex I only for the version that it has last placed on the market, provided that the users of the versions that were previously placed on the market have access to the version last placed on the market free of charge and do not incur additional costs to adjust the hardware and software environment in which they use the original version of that product.

11.   Manufacturers may maintain public software archives enhancing user access to historical versions. In those cases, users shall be clearly informed in an easily accessible manner about risks associated with using unsupported software.

12.   Before placing a product with digital elements on the market, manufacturers shall draw up the technical documentation referred to in Article 31.

They shall carry out the chosen conformity assessment procedures as referred to in Article 32 or have them carried out.

Where compliance of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I and of the processes put in place by the manufacturer with the essential cybersecurity requirements set out in Part II of Annex I has been demonstrated by that conformity assessment procedure, manufacturers shall draw up the EU declaration of conformity in accordance with Article 28 and affix the CE marking in accordance with Article 30.

13.   Manufacturers shall keep the technical documentation and the EU declaration of conformity at the disposal of the market surveillance authorities for at least 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer.

14.   Manufacturers shall ensure that procedures are in place for products with digital elements that are part of a series of production to remain in conformity with this Regulation. Manufacturers shall adequately take into account changes in the development and production process or in the design or characteristics of the product with digital elements and changes in the harmonised standards, European cybersecurity certification schemes or common specifications as referred to in Article 27 by reference to which the conformity of the product with digital elements is declared or by application of which its conformity is verified.

15.   Manufacturers shall ensure that their products with digital elements bear a type, batch or serial number or other element allowing their identification, or, where that is not possible, that that information is provided on their packaging or in a document accompanying the product with digital elements.

16.   Manufacturers shall indicate the name, registered trade name or registered trademark of the manufacturer, and the postal address, email address or other digital contact details, as well as, where applicable, the website where the manufacturer can be contacted, on the product with digital elements, on its packaging or in a document accompanying the product with digital elements. That information shall also be included in the information and instructions to the user set out in Annex II. The contact details shall be in a language which can be easily understood by users and market surveillance authorities.

17.   For the purposes of this Regulation, manufacturers shall designate a single point of contact to enable users to communicate directly and rapidly with them, including in order to facilitate reporting on vulnerabilities of the product with digital elements.

Manufacturers shall ensure that the single point of contact is easily identifiable by the users. They shall also include the single point of contact in the information and instructions to the user set out in Annex II.

The single point of contact shall allow users to choose their preferred means of communication and shall not limit such means to automated tools.

18.   Manufacturers shall ensure that products with digital elements are accompanied by the information and instructions to the user set out in Annex II, in paper or electronic form. Such information and instructions shall be provided in a language which can be easily understood by users and market surveillance authorities. They shall be clear, understandable, intelligible and legible. They shall allow for the secure installation, operation and use of products with digital elements. Manufacturers shall keep the information and instructions to the user set out in Annex II at the disposal of users and market surveillance authorities for at least 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer. Where such information and instructions are provided online, manufacturers shall ensure that they are accessible, user-friendly and available online for at least 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer.

19.   Manufacturers shall ensure that the end date of the support period referred to in paragraph 8, including at least the month and the year, is clearly and understandably specified at the time of purchase in an easily accessible manner and, where applicable, on the product with digital elements, its packaging or by digital means.

Where technically feasible in light of the nature of the product with digital elements, manufacturers shall display a notification to users informing them that their product with digital elements has reached the end of its support period.

20.   Manufacturers shall either provide a copy of the EU declaration of conformity or a simplified EU declaration of conformity with the product with digital elements. Where a simplified EU declaration of conformity is provided, it shall contain the exact internet address at which the full EU declaration of conformity can be accessed.

21.   From the placing on the market and for the support period, manufacturers who know or have reason to believe that the product with digital elements or the processes put in place by the manufacturer are not in conformity with the essential cybersecurity requirements set out in Annex I shall immediately take the corrective measures necessary to bring that product with digital elements or the manufacturer’s processes into conformity, or to withdraw or recall the product, as appropriate.

22.   Manufacturers shall, upon a reasoned request from a market surveillance authority, provide that authority, in a language which can be easily understood by that authority, with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the product with digital elements and of the processes put in place by the manufacturer with the essential cybersecurity requirements set out in Annex I. Manufacturers shall cooperate with that authority, at its request, on any measures taken to eliminate the cybersecurity risks posed by the product with digital elements which they have placed on the market.

23.   A manufacturer that ceases its operations and, as a result, is not able to comply with this Regulation shall inform, before the cessation of operations takes effect, the relevant market surveillance authorities as well as, by any means available and to the extent possible, the users of the relevant products with digital elements placed on the market, of the impending cessation of operations.

24.   The Commission may, by means of implementing acts taking into account European or international standards and best practices, specify the format and elements of the software bill of materials referred to in Part II, point (1), of Annex I. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 62(2).

25.   In order to assess the dependence of Member States and of the Union as a whole on software components and in particular on components qualifying as free and open-source software, ADCO may decide to conduct a Union wide dependency assessment for specific categories of products with digital elements. For that purpose, market surveillance authorities may request manufacturers of such categories of products with digital elements to provide the relevant software bills of materials as referred to in Part II, point (1), of Annex I. On the basis of such information, the market surveillance authorities may provide ADCO with anonymised and aggregated information about software dependencies. ADCO shall submit a report on the results of the dependency assessment to the Cooperation Group established pursuant to Article 14 of Directive (EU) 2022/2555.

1.   A manufacturer shall notify any actively exploited vulnerability contained in the product with digital elements that it becomes aware of simultaneously to the CSIRT designated as coordinator, in accordance with paragraph 7 of this Article, and to ENISA. The manufacturer shall notify that actively exploited vulnerability via the single reporting platform established pursuant to Article 16.

2.   For the purposes of the notification referred to in paragraph 1, the manufacturer shall submit:

3.   A manufacturer shall notify any severe incident having an impact on the security of the product with digital elements that it becomes aware of simultaneously to the CSIRT designated as coordinator, in accordance with paragraph 7 of this Article, and to ENISA. The manufacturer shall notify that incident via the single reporting platform established pursuant to Article 16.

4.   For the purposes of the notification referred to in paragraph 3, the manufacturer shall submit:

5.   For the purposes of paragraph 3, an incident having an impact on the security of the product with digital elements shall be considered to be severe where:

6.   Where necessary, the CSIRT designated as coordinator initially receiving the notification may request manufacturers to provide an intermediate report on relevant status updates about the actively exploited vulnerability or severe incident having an impact on the security of the product with digital elements.

7.   The notifications referred to in paragraphs 1 and 3 of this Article shall be submitted via the single reporting platform referred to in Article 16 using one of the electronic notification end-points referred to in Article 16(1). The notification shall be submitted using the electronic notification end-point of the CSIRT designated as coordinator of the Member State where the manufacturers have their main establishment in the Union and shall be simultaneously accessible to ENISA.

For the purposes of this Regulation, a manufacturer shall be considered to have its main establishment in the Union in the Member State where the decisions related to the cybersecurity of its products with digital elements are predominantly taken. If such a Member State cannot be determined, the main establishment shall be considered to be in the Member State where the manufacturer concerned has the establishment with the highest number of employees in the Union.

Where a manufacturer has no main establishment in the Union, it shall submit the notifications referred to in paragraphs 1 and 3 using the electronic notification end-point of the CSIRT designated as coordinator in the Member State determined pursuant to the following order and based on the information available to the manufacturer:

In relation to the third subparagraph, point (d), a manufacturer may submit notifications related to any subsequent actively exploited vulnerability or severe incident having an impact on the security of the product with digital elements to the same CSIRT designated as coordinator to which it first reported.

8.   After becoming aware of an actively exploited vulnerability or a severe incident having an impact on the security of the product with digital elements, the manufacturer shall inform the impacted users of the product with digital elements, and where appropriate all users, of that vulnerability or incident and, where necessary, of any risk mitigation and corrective measures that the users can deploy to mitigate the impact of that vulnerability or incident, where appropriate in a structured, machine-readable format that is easily automatically processable. Where the manufacturer fails to inform the users of the product with digital elements in a timely manner, the notified CSIRTs designated as coordinators may provide such information to the users when considered to be proportionate and necessary for preventing or mitigating the impact of that vulnerability or incident.

9.   By 11 December 2025, the Commission shall adopt delegated acts in accordance with Article 61 of this Regulation to supplement this Regulation by specifying the terms and conditions for applying the cybersecurity-related grounds in relation to delaying the dissemination of notifications as referred to in Article 16(2) of this Regulation. The Commission shall cooperate with the CSIRTs network established pursuant to Article 15 of Directive (EU) 2022/2555 and ENISA in preparing the draft delegated acts.

10.   The Commission may, by means of implementing acts, specify further the format and procedures of the notifications referred to in this Article as well as in Articles 15 and 16. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 62(2). The Commission shall cooperate with the CSIRTs network and ENISA in preparing those draft implementing acts.