Article 35 - Market surveillance and control of products entering the Union market

Regulation (EU) 2019/945

1. Member States shall organise and perform surveillance of the products that are placed on the Union market in accordance with paragraph 3 of Article 15 and Articles 16 to 26 of Regulation (EC) No 765/2008.

2. Member States shall organise and perform control of the products that enter the Union market in accordance with paragraph 5 of Article 15 and Articles 27, 28 and 29 of Regulation (EC) No 765/2008.

3. Member States shall ensure that their market surveillance and border control authorities cooperate with the competent authorities designated under Article 17 of Implementing Regulation (EU) 2019/947 on safety matters and shall establish appropriate communication and coordination mechanisms between them, making the best use of the information contained in the occurrence reporting system defined in Regulation (EU) No 376/2014 of the European Parliament and of the Council110 Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18). and the information systems defined in Articles 22 and 23 of Regulation (EC) No 765/2008.

Article 36 - Procedure for dealing with products presenting a risk at national level

Regulation (EU) 2020/1058

1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a product presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this Chapter, they shall carry out an evaluation in relation to the product concerned, covering all applicable requirements laid down in this Chapter. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the product does not comply with the requirements laid down in this Chapter, they shall, without delay, require the relevant economic operator to take all appropriate corrective actions to bring the product into compliance with those requirements, to withdraw the product from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.

The market surveillance authorities shall inform the relevant notified body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.

2. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

3. The economic operator shall ensure that all appropriate corrective action is taken in respect of all products concerned that it has made available on the market throughout the Union.

4. Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the product being made available on their national market, to withdraw the product from that market or to recall it.

The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.

5. The information referred to in paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, 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 economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either of the following:

(a) failure of the product to meet the requirements set out in Article 4;

(b) shortcomings in the harmonised standards referred to in Article 12.

6. Member States other than the Member State initiating the procedure under this Article 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 concerned, and, in the event of disagreement with the adopted national measure, of their objections.

7. Where, within three months of receipt of the information referred to in paragraph 5, 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 justified.

8. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the product from the market, are taken in respect of the product concerned without delay.

Article 37 - Union safeguard procedure

Regulation (EU) 2019/945

1. Where, on completion of the procedure set out in paragraphs 3 and 4 of Article 36, 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 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.

The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.

2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant product is withdrawn or recalled from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure.

3. Where the national measure is considered justified and the non-compliance of the product is attributed to shortcomings in the harmonised standards referred to in point (b) of paragraph 5 of Article 36 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

Article 38 - Compliant product which presents a risk

Regulation (EU) 2019/945

1. Where, having carried out an evaluation under paragraph 1 of Article 36, a Member State finds that, although the product is in compliance with this Chapter, it presents a risk to the health or safety of persons or to other aspects of public interest protection covered by this Chapter, it shall require the relevant economic operator to take all appropriate measures to ensure that the product concerned, when placed on the market, no longer presents that risk, to withdraw the product from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.

2. The economic operator shall ensure that corrective action is taken in respect of all the products concerned that he has made available on the market throughout the Union.

3. The Member State shall 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 product, 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 or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not and, where necessary, propose appropriate measures.

5. The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.

Article 39 - Formal non-compliance

Regulation (EU) 2019/945

1. Without prejudice to Article 36, where a Member State makes one of the following findings concerning products covered by this Chapter, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 15 or Article 16 of this Regulation;

(b) the CE marking or type has not been affixed;

(c) the identification number of the notified body, where the conformity assessment procedure set out in Part 9 of the Annex is applied, has been affixed in violation of Article 16 or has not been affixed;

(d) the UA class identification label has not been affixed;

(e) the indication of the sound power level if required has not been affixed;

(f) the serial number has not been affixed or has not the correct format;

(g) the manual or the information notice is not available;

(h) the EU declaration of conformity is missing or has not been drawn up;

(i) the EU declaration of conformity has not been drawn up correctly;

(j) technical documentation is either not available or not complete;

(k) manufacturer’s or importer’s name, registered trade name or registered trademark, website address or postal address are missing.

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 being made available on the market or ensure that it is withdrawn or recalled from the market.