1. Regulation (EU) 2019/1020 shall apply to products with digital elements that fall within the scope of this Regulation.
2. Each Member State shall designate one or more market surveillance authorities for the purpose of ensuring the effective implementation of this Regulation. Member States may designate an existing or new authority to act as market surveillance authority for this Regulation.
3. The market surveillance authorities designated under paragraph 2 of this Article shall also be responsible for carrying out market surveillance activities in relation to the obligations for open-source software stewards laid down in Article 24. Where a market surveillance authority finds that an open-source software steward does not comply with the obligations set out in that Article, it shall require the open-source software steward to ensure that all appropriate corrective actions are taken. Open-source software stewards shall ensure that all appropriate corrective action is taken in respect of their obligations under this Regulation.
4. Where relevant, the market surveillance authorities shall cooperate with the national cybersecurity certification authorities designated pursuant to Article 58 of Regulation (EU) 2019/881 and exchange information on a regular basis. With respect to the supervision of the implementation of the reporting obligations pursuant to Article 14 of this Regulation, the designated market surveillance authorities shall cooperate and exchange information on a regular basis with the CSIRTs designated as coordinators and ENISA.
5. The market surveillance authorities may request a CSIRT designated as coordinator or ENISA to provide technical advice on matters related to the implementation and enforcement of this Regulation. When conducting an investigation under Article 54, market surveillance authorities may request the CSIRT designated as coordinator or ENISA to provide an analysis to support evaluations of compliance of products with digital elements.
6. Where relevant, the market surveillance authorities shall cooperate with other market surveillance authorities designated on the basis of Union harmonisation legislation other than this Regulation, and exchange information on a regular basis.
7. Market surveillance authorities shall cooperate, as appropriate, with the authorities supervising Union data protection law. Such cooperation includes informing those authorities of any finding relevant for the fulfilment of their competences, including when issuing guidance and advice pursuant to paragraph 10 if such guidance and advice concerns the processing of personal data.
   Authorities supervising Union data protection law shall have the power to request and access any documentation created or maintained under this Regulation when access to that documentation is necessary for the fulfilment of their tasks. They shall inform the designated market surveillance authorities of the Member State concerned of any such request.
8. Member States shall ensure that the designated market surveillance authorities are provided with adequate financial and technical resources, including, where appropriate, processing automation tools, as well as with human resources with the necessary cybersecurity skills to fulfil their tasks under this Regulation.
9. The Commission shall encourage and facilitate the exchange of experience between designated market surveillance authorities.
10. Market surveillance authorities may provide guidance and advice to economic operators on the implementation of this Regulation, with the support of the Commission and, where appropriate, CSIRTs and ENISA.
11. Market surveillance authorities shall inform consumers of where to submit complaints that could indicate non-compliance with this Regulation, in accordance with Article 11 of Regulation (EU) 2019/1020, and shall provide information to consumers on where and how to access mechanisms to facilitate reporting of vulnerabilities, incidents and cyber threats that may affect products with digital elements.
12. Market surveillance authorities shall facilitate, where relevant, the cooperation with relevant stakeholders, including scientific, research and consumer organisations.
13. The market surveillance authorities shall report to the Commission on an annual basis the outcomes of relevant market surveillance activities. The designated market surveillance authorities shall report, without delay, 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 competition law.
14. For products with digital elements that fall within the scope of this Regulation which are classified as high-risk AI systems pursuant to Article 6 of Regulation (EU) 2024/1689, the market surveillance authorities designated for the purposes of that Regulation shall be the authorities responsible for market surveillance activities required under this Regulation. The market surveillance authorities designated pursuant to Regulation (EU) 2024/1689 shall cooperate, as appropriate, with the market surveillance authorities designated pursuant to this Regulation and, with respect to the supervision of the implementation of the reporting obligations pursuant to Article 14 of this Regulation, with the CSIRTs designated as coordinators and ENISA. Market surveillance authorities designated pursuant to Regulation (EU) 2024/1689 shall in particular inform market surveillance authorities designated pursuant to this Regulation of any finding relevant for the fulfilment of their tasks in relation to the implementation of this Regulation.
15. ADCO shall be established for the uniform application of this Regulation, pursuant to Article 30(2) of Regulation (EU) 2019/1020. ADCO shall be composed of representatives of the designated market surveillance authorities and, if appropriate, representatives of single liaison offices. ADCO shall also address specific matters related to the market surveillance activities in relation to the obligations placed on open-source software stewards.
16. Market surveillance authorities shall monitor how manufacturers have applied the criteria referred to in Article 13(8) when determining the support period of their products with digital elements.
    ADCO shall publish in a publicly accessible and user-friendly form relevant statistics on categories of products with digital elements, including average support periods, as determined by the manufacturer pursuant to Article 13(8), as well as provide guidance that includes indicative support periods for categories of products with digital elements.
    Where the data suggests inadequate support periods for specific categories of products with digital elements, ADCO may issue recommendations to market surveillance authorities to focus their activities on such categories of products with digital elements.

Where necessary to assess the conformity of products with digital elements and the processes put in place by their manufacturers with the essential cybersecurity requirements set out in Annex I, the market surveillance authorities shall, upon a reasoned request, be granted access to the data, in a language easily understood by them, required to assess the design, development, production and vulnerability handling of such products, including related internal documentation of the relevant economic operator.

1. Where the market surveillance authority of a Member State has sufficient reason to consider that a product with digital elements, including its vulnerability handling, presents a significant cybersecurity risk, it shall, without undue delay and, where appropriate, in cooperation with the relevant CSIRT, carry out an evaluation of the product with digital elements concerned in respect of its compliance with all the requirements laid down in this Regulation. The relevant economic operators shall cooperate with the market surveillance authority as necessary.
   Where, in the course of that evaluation, the market surveillance authority finds that the product with digital elements does not comply with the requirements laid down in this Regulation, it shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the product with digital elements into compliance with those requirements, to withdraw it from the market, or to recall it within a reasonable period, commensurate with the nature of the cybersecurity risk, as the market surveillance authority may prescribe.
   The market surveillance authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the corrective actions.
2. When determining the significance of a cybersecurity risk referred to in paragraph 1 of this Article, the market surveillance authorities shall also consider non-technical risk factors, in particular those established as a result of Union level coordinated security risk assessments of critical supply chains carried out in accordance with Article 22 of Directive (EU) 2022/2555. Where a market surveillance authority has sufficient reason to consider that a product with digital elements presents a significant cybersecurity risk in light of non-technical risk factors, it shall inform the competent authorities designated or established pursuant to Article 8 of Directive (EU) 2022/2555 and cooperate with those authorities as necessary.
3. Where the market surveillance authority considers that non-compliance is not restricted to its national territory, it shall inform the Commission and the other Member States of the results of the evaluation and of the actions which it has required the economic operator to take.
4. The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products with digital elements concerned that it has made available on the market throughout the Union.
5. Where the economic operator does not take adequate corrective action within the period referred to in paragraph 1, second subparagraph, the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict that product with digital elements from being made available on its national market, to withdraw it from that market or to recall it.
   That authority shall notify the Commission and the other Member States, without delay, of those measures.
6. The information referred to in paragraph 5 shall include all available details, in particular the data necessary for the identification of the non-compliant product with digital elements, the origin of that product with digital elements, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authority shall indicate whether the non-compliance is due to one or more of the following:
   • (a) a failure of the product with digital elements or of the processes put in place by the manufacturer to meet the essential cybersecurity requirements set out in Annex I;
   • (b) shortcomings in the harmonised standards, European cybersecurity certification schemes or common specifications, as referred to in Article 27.
7. The market surveillance authorities of the Member States other than the market surveillance authority of the Member State initiating the procedure shall without 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 product with digital elements 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 Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed to be justified. This is without prejudice to the procedural rights of the economic operator concerned in accordance with Article 18 of Regulation (EU) 2019/1020.
9. The market surveillance authorities of all Member States shall ensure that appropriate restrictive measures are taken in respect of the product with digital elements concerned, such as withdrawal of that product from their market, without delay.

1. Where, within three months of receipt of the notification referred to in Article 54(5), objections are raised by a Member State against a measure taken by another Member State, or where the Commission considers the measure to be contrary to Union law, the Commission shall without delay enter into consultation with the relevant Member State and the economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not within nine months from the notification referred to in Article 54(5) and notify that decision to the Member State concerned.
2. If the national measure is considered to be justified, all Member States shall take the measures necessary to ensure that the non-compliant product with digital elements is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is not considered to be justified, the Member State concerned shall withdraw the measure.
3. Where the national measure is considered to be justified and the non-compliance of the product with digital elements is attributed to shortcomings in the harmonised standards, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
4. Where the national measure is considered to be justified and the non-compliance of the product with digital elements is attributed to shortcomings in a European cybersecurity certification scheme as referred to in Article 27, the Commission shall consider whether to amend or repeal any delegated act adopted pursuant to Article 27(9) that specifies the presumption of conformity concerning that certification scheme.
5. Where the national measure is considered to be justified and the non-compliance of the product with digital elements is attributed to shortcomings in common specifications as referred to in Article 27, the Commission shall consider whether to amend or repeal any implementing act adopted pursuant to Article 27(2) setting out those common specifications.

1. Where the Commission has sufficient reason to consider, including based on information provided by ENISA, that a product with digital elements that presents a significant cybersecurity risk does not comply with the requirements laid down in this Regulation, it shall inform the relevant market surveillance authorities. Where the market surveillance authorities carry out an evaluation of that product with digital elements that may present a significant cybersecurity risk in respect of its compliance with the requirements laid down in this Regulation, the procedures referred to in Articles 54 and 55 shall apply.
2. Where the Commission has sufficient reason to consider that a product with digital elements presents a significant cybersecurity risk in light of non-technical risk factors, it shall inform the relevant market surveillance authorities and, where appropriate, the competent authorities designated or established pursuant to Article 8 of Directive (EU) 2022/2555 and cooperate with those authorities as necessary. The Commission shall also consider the relevance of the identified risks for that product with digital elements in view of its tasks regarding the Union level coordinated security risk assessments of critical supply chains provided for in Article 22 of Directive (EU) 2022/2555, and consult, as necessary, the Cooperation Group established pursuant to Article 14 of Directive (EU) 2022/2555 and ENISA.
3. In circumstances which justify an immediate intervention to preserve the proper functioning of the internal market and where the Commission has sufficient reason to consider that the product with digital elements referred to in paragraph 1 remains non-compliant with the requirements laid down in this Regulation and no effective measures have been taken by the relevant market surveillance authorities, the Commission shall carry out an evaluation of compliance and may request ENISA to provide an analysis to support it. The Commission shall inform the relevant market surveillance authorities accordingly. The relevant economic operators shall cooperate with ENISA as necessary.
4. Based on the evaluation referred to in paragraph 3, the Commission may decide that a corrective or restrictive measure is necessary at Union level. To that end, it shall without delay consult the Member States concerned and the relevant economic operator or operators.
5. On the basis of the consultation referred to in paragraph 4 of this Article, the Commission may adopt implementing acts to provide for corrective or restrictive measures at Union level, including requiring the products with digital elements concerned to be withdrawn from the market or recalled, within a reasonable period, commensurate with the nature of the risk. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 62(2).
6. The Commission shall immediately communicate the implementing acts referred to in paragraph 5 to the relevant economic operator or operators. Member States shall implement those implementing acts without delay and shall inform the Commission accordingly.
7. Paragraphs 3 to 6 shall be applicable for the duration of the exceptional situation that justified the Commission’s intervention, provided that the product with digital elements concerned is not brought in compliance with this Regulation.

1. The market surveillance authority of a Member State shall require an economic operator to take all appropriate measures where, having performed an evaluation under Article 54, it finds that although a product with digital elements and the processes put in place by the manufacturer are in compliance with this Regulation, they present a significant cybersecurity risk as well as a risk to:
   • (a) the health or safety of persons;
   • (b) the compliance with obligations under Union or national law intended to protect fundamental rights;
   • (c) the availability, authenticity, integrity or confidentiality of services offered using an electronic information system by essential entities as referred to in Article 3(1) of Directive (EU) 2022/2555; or
   • (d) other aspects of public interest protection.
   The measures referred to in the first subparagraph may include measures to ensure that the product with digital elements concerned and the processes put in place by the manufacturer no longer present the relevant risks when made available on the market, withdrawal from the market of the product with digital elements concerned, or recalling of it, and shall be commensurate with the nature of those risks.
2. The manufacturer or other relevant economic operators shall ensure that corrective action is taken in respect of the products with digital elements concerned that they have made available on the market throughout the Union within the timeline established by the market surveillance authority of the Member State referred to in paragraph 1.
3. The Member State shall immediately inform the Commission and the other Member States about the measures taken pursuant to paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the products with digital elements concerned, the origin and the supply chain of those products with digital elements, the nature of the risk involved and the nature and duration of the national measures taken.
4. The Commission shall without delay enter into consultation with the Member States and the relevant economic operator 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 or not and, where necessary, propose appropriate measures.
5. The Commission shall address the decision referred to in paragraph 4 to the Member States.
6. Where the Commission has sufficient reason to consider, including based on information provided by ENISA, that a product with digital elements, although compliant with this Regulation, presents the risks referred to in paragraph 1 of this Article, it shall inform and may request the relevant market surveillance authority or authorities to carry out an evaluation and follow the procedures referred to in Article 54 and in paragraphs 1, 2 and 3 of this Article.
7. In circumstances which justify an immediate intervention to preserve the proper functioning of the internal market and where the Commission has sufficient reason to consider that the product with digital elements referred to in paragraph 6 continues to present the risks referred to in paragraph 1, and no effective measures have been taken by the relevant national market surveillance authorities, the Commission shall carry out an evaluation of the risks presented by that product with digital elements and may request ENISA to provide an analysis to support that evaluation and shall inform the relevant market surveillance authorities accordingly. The relevant economic operators shall cooperate with ENISA as necessary.
8. Based on the evaluation referred to in paragraph 7, the Commission may establish that a corrective or restrictive measure is necessary at Union level. To that end, it shall without delay consult the Member States concerned and the relevant economic operator or operators.
9. On the basis of the consultation referred to in paragraph 8 of this Article, the Commission may adopt implementing acts to decide on corrective or restrictive measures at Union level, including requiring the products with digital elements concerned to be withdrawn from the market, or recalled, within a reasonable period, commensurate with the nature of the risk. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 62(2).
10. The Commission shall immediately communicate the implementing acts referred to in paragraph 9 to the relevant economic operator or operators. Member States shall implement those implementing acts without delay and shall inform the Commission accordingly.
11. Paragraphs 6 to 10 shall apply for the duration of the exceptional situation that justified the Commission’s intervention and for as long as the product with digital elements concerned continues to present the risks referred to in paragraph 1.

1. Where the market surveillance authority of a Member State makes one of the following findings, it shall require the relevant manufacturer to put an end to the non-compliance concerned:
   • (a) the CE marking has been affixed in violation of Articles 29 and 30;
   • (b) the CE marking has not been affixed;
   • (c) the EU declaration of conformity has not been drawn up;
   • (d) the EU declaration of conformity has not been drawn up correctly;
   • (e) the identification number of the notified body which is involved in the conformity assessment procedure, where applicable, has not been affixed;
   • (f) the technical documentation is either not available or not complete.
2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product with digital elements from being made available on the market or ensure that it is recalled or withdrawn from the market.

1. Market surveillance authorities may agree with other relevant authorities to carry out joint activities aimed at ensuring cybersecurity and the protection of consumers with respect to specific products with digital elements placed on the market or made available on the market, in particular products with digital elements that are often found to present cybersecurity risks.
2. The Commission or ENISA shall propose joint activities for checking compliance with this Regulation to be conducted by market surveillance authorities based on indications or information of potential non-compliance across several Member States of products with digital elements that fall within the scope of this Regulation with the requirements laid down in this Regulation.
3. The market surveillance authorities and, where applicable, the Commission, shall ensure that the agreement to carry out joint activities does not lead to unfair competition between economic operators and does not negatively affect the objectivity, independence and impartiality of the parties to the agreement.
4. A market surveillance authority may use any information obtained as a result of the joint activities carried out as part of any investigation that it undertakes.
5. The market surveillance authority concerned and, where applicable, the Commission, shall make the agreement on joint activities, including the names of the parties involved, available to the public.

1. Market surveillance authorities shall conduct simultaneous coordinated control actions (sweeps) of particular products with digital elements or categories thereof to check compliance with or to detect infringements to this Regulation. Those sweeps may include inspections of products with digital elements acquired under a cover identity.
2. Unless otherwise agreed upon by the market surveillance authorities involved, sweeps shall be coordinated by the Commission. The coordinator of the sweep shall, where appropriate, make the aggregated results publicly available.
3. Where, in the performance of its tasks, including based on the notifications received pursuant to Article 14(1) and (3), ENISA identifies categories of products with digital elements for which sweeps may be organised, it shall submit a proposal for a sweep to the coordinator referred to in paragraph 2 of this Article for the consideration of the market surveillance authorities.
4. When conducting sweeps, the market surveillance authorities involved may use the investigation powers set out in Articles 52 to 58 and any other powers conferred upon them by national law.
5. Market surveillance authorities may invite Commission officials, and other accompanying persons authorised by the Commission, to participate in sweeps.