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Regulation (EU) 2024/3110 CHAPTER VIII — MARKET SURVEILLANCE AND SAFEGUARD PROCEDURES

Article 63–Article 70 · 8 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Complaint portal

Article 63

1.   Without prejudice to the obligations of economic operators under this Regulation and the activities of market surveillance authorities under Regulation (EU) 2019/1020, the Commission shall set up a system allowing any natural or legal person to share complaints or reports related to possible non-compliance with this Regulation. 2.   Where the Commission considers a complaint or report relevant and substantiated based on clearly defined criteria, it shall without undue delay transmit that complaint or report to the single liaison point of the Member State concerned for that single liaison point to follow-up with the relevant natural or legal person in accordance with Article 11(7), point (a) of Regulation (EU) 2019/1020.

Market surveillance authorities and single liaison point

Article 64

1.   Member States shall designate, amongst their market surveillance authorities, one or more authorities that dispose of the particular knowledge needed to assess products both technically and legally. 2.   Member States shall designate a single liaison point to act as the focal point for contacts with the Commission and single liaison points of other Member States which are competent under this Regulation, including for requests pursuant to Articles 22, 23 and 24 of Regulation (EU) 2019/1020. 3.   Market surveillance authorities designated in accordance with paragraph 1 of this Article shall have all the powers listed in Article 14 of Regulation (EU) 2019/1020. For the purposes of this Regulation those powers shall also apply to all economic operators covered by this Regulation. 4.   For the purpose of market surveillance, investigation and enforcement, market surveillance authorities shall have the power to request from other authorities or bodies relevant information in their possession.

Procedure to deal with non-compliance

Article 65

1.   Where a market surveillance authority of one Member State has sufficient reason to believe that certain products covered by a harmonised technical specification or for which a European technical assessment has been issued, or their manufacturer, are non-compliant, it shall carry out an evaluation in relation to those products and the manufacturer concerned covering the respective requirements laid down by this Regulation. The relevant economic operators shall, as necessary, cooperate with the market surveillance authorities. Where, in the course of that evaluation, the market surveillance authority finds that the products or their manufacturer do not comply with the requirements and obligations laid down in this Regulation, it shall without delay require the relevant economic operator to take appropriate and proportionate corrective actions, as provided for in Article 16(3) of Regulation (EU) 2019/1020, to bring the non-compliance to an end or, if that is not possible, to withdraw the products from the market, or to recall them, all within a reasonable period which is commensurate with the nature of the non-compliance. The market surveillance authority shall inform the notified bodies accordingly, if notified bodies are involved. 2.   Where the market surveillance authority considers that the non-compliance is not limited to its national territory, it shall, via the single liaison point, 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. 3.   The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union. 4.   Where the relevant economic operator, within the period referred to in the second subparagraph of paragraph 1, does not take the corrective action referred to in paragraph 1, second subparagraph, or where the non-compliance persists, the market surveillance authority shall ensure that the product concerned is withdrawn or recalled, or that making it available on the market is prohibited or restricted. The market surveillance authority shall inform the public, and via the single liaison point the Commission and the other Member States, without delay, of those measures. 5.   The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant products, the origin of those products, the nature of the non-compliance alleged and the risk involved, the nature and duration of national measures taken as well as the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following: (a) failure of the products to achieve the declared performance; (b) failure of the products to meet product requirements established by delegated acts referred to in Article 7(1); (c) failure of the manufacturer to meet obligations; (d) shortcomings in the harmonised technical specifications, in a European assessment document, in the voluntary harmonised standards for product requirements the references of which have been published in the Official Journal of the European Union in accordance with Article 7(5) or (6) or in the common specifications established by implementing acts referred to in Article 8(1). 6.   Member States other than 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 products concerned, and, in the event of disagreement with the notified national measure, of their objections. 7.   Where, within two months of receipt of the information referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State in relation to the product concerned, that measure shall be deemed justified. 8.   Member States shall ensure that appropriate restrictive measures are taken without delay in respect of the product or manufacturer concerned, such as withdrawal of the products from their market.

Union safeguard procedure

Article 66

1.   Where, on completion of the procedure set out in Article 65(4), (6) and (7), objections are raised against a measure taken by a Member State or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator and shall evaluate the national measure. The consultation period shall not exceed two months. On the basis of the results of that evaluation, the Commission shall endeavour to adopt implementing acts, within two additional months, after the end of consultation period, setting out its decision as to whether the measure is justified or not. Those implementing acts shall be adopted in accordance with the advisory procedure referred in Article 90(2). The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator. 2.   If the national measure is considered to be justified, all Member States shall, without delay, ensure that appropriate restrictive measures, such as withdrawal, are taken in respect of the non-compliant product and shall inform the Commission accordingly. If the national measure is considered to be unjustified, 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 or its manufacturer is attributed to shortcomings in the harmonised technical specifications, European assessment documents, voluntary harmonised standards or common specifications established by implementing acts as referred to in Article 65(5), point (d), the Commission shall apply the procedure provided for in Article 5(9), Article 6(5), Article 7(6) or Article 36 of this Regulation or in Article 11 of Regulation (EU) No 1025/2012, as appropriate.

Compliant products which nevertheless present a risk

Article 67

1.   Where, having performed an evaluation pursuant to Article 65(1), a market surveillance authority finds that, although a product is in compliance with this Regulation, it presents a risk to the health or safety of persons or, where applicable, to the environment or to other aspects of public interest protection, it shall require the relevant economic operator to take all appropriate measures to ensure that the products concerned, when placed on the market, no longer present that risk, to withdraw the products from the market or to recall them within a reasonable period, commensurate with the nature of the risk, which it may prescribe. 2.   The economic operator shall ensure that any corrective action is taken in respect of all the products concerned which that economic operator has made available on the market throughout the Union. 3.   The market surveillance authority shall, via the single liaison point, immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken. 4.   The Commission shall without delay consult the Member States and the relevant economic operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act setting out its decision whether the measure is justified or not and, where necessary, ordering appropriate measures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 90(2). 5.   The Commission shall address its decision to all Member States and shall immediately communicate it to them and to the relevant economic operator.

Market surveillance coordination and support

Article 68

1.   For the purposes of this Regulation, the administrative cooperation group set up pursuant to Article 30(2) of Regulation (EU) 2019/1020 (‘ADCO’) shall meet at regular intervals and, where necessary, at the reasoned request of the Commission or of two or more participating market surveillance authorities. In the context of performing its tasks set out in Article 32 of Regulation (EU) 2019/1020, the ADCO shall support the implementation of this Regulation, namely by identifying common priorities for market surveillance. 2.   Based on priorities identified in consultation with the ADCO, the Commission shall: (a) organise joint market surveillance and testing projects in areas of common interest; (b) organise joint investment in market surveillance capacities, including equipment and IT tools; (c) organise common trainings for the staff of market surveillance authorities, notifying authorities and notified bodies, including on the correct interpretation and application of this Regulation and on methods and techniques relevant for applying or verifying compliance with it; (d) draw up guidelines for the application and enforcement of this Regulation, including requirements and obligations set out in harmonised technical specifications adopted pursuant to this Regulation, as well as common practices and methodologies for effective market surveillance. The Union shall, where appropriate, finance the actions referred to in points (a), (b) and (c). 3.   The Commission shall provide technical and logistic support to ensure that the ADCO fulfils its tasks set out in this Article and in Article 32 of Regulation (EU) 2019/1020.

Recovery of costs

Article 69

Where a product has been found to be non-compliant, market surveillance authorities shall have the right to recover from the economic operators who placed or made the product available on the market the costs of document inspection and physical product testing, provided that those costs are accompanied by a justification.

Reporting and benchmarking

Article 70

1.   Market surveillance authorities shall enter into the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 information on the nature and severity of any penalty imposed in relation to non-compliance with this Regulation. 2.   Every four years, by 30 June, the Commission shall, draw up a report based on the information entered by market surveillance authorities into the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020. The first of those reports shall be published by 9 January 2030. The report shall include: (a) information on the nature and number of checks performed by market surveillance authorities during the four previous calendar years pursuant to Article 34(4) and (5) of Regulation (EU) 2019/1020; (b) information on the levels of non-compliance identified and on the nature and severity of penalties imposed for the four previous calendar years in relation to products covered by harmonised technical specifications or CE marked based on a European technical assessment; (c) indicative benchmarks for market surveillance authorities in relation to the frequency of checks and the nature and severity of penalties imposed. 3.   The Commission shall publish the report referred to in paragraph 2 of this Article in the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and shall make public a summary of the report.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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