第69条 国レベルでリスクをもたらす製品に対処するための手続

1. Where the market surveillance authorities have sufficient reason to believe that a product covered by a delegated act adopted pursuant to Article 4 presents a risk, they shall carry out an evaluation covering all requirements relevant to the risk and laid down in this Regulation or in that delegated act.

Where, in the course of that evaluation, the market surveillance authorities find that the product does not comply with the requirements laid down in this Regulation or in the applicable delegated act adopted pursuant to Article 4, they shall without delay require the relevant economic operator to take appropriate and proportionate corrective action, within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature and, where relevant, the degree of the non-compliance, to bring the non-compliance to an end. That corrective action may include, inter alia, the actions listed in Article 16(3) of Regulation (EU) 2019/1020.

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

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 corrective action which they have required the economic operator to take.

3. The relevant 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 does not take corrective action within the period referred to in paragraph 1, second subparagraph, or the non-compliance persists, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the making available of the product concerned on their national market, to withdraw it from that market or to recall it.

They shall inform the Commission and the other Member States, without delay, of those measures.

5. The information to be provided to the Commission and the other Member States in accordance with paragraph 4 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and 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 non-compliance involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. The market surveillance authorities shall also indicate whether the non-compliance is due to either:

(a)the failure of the product to meet requirements set out in the relevant delegated act adopted pursuant to Article 4 of this Regulation; or

(b)shortcomings in the harmonised standards or common specifications referred to in Articles 41 and 42 of this Regulation conferring a presumption of conformity.

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 product concerned, and, in the event of disagreement with the notified national measure, of their objections.

7. Where, within three 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, that measure shall be deemed justified. That provisional measure may specify a period other than three months in order to take account of the specificities of the products or requirements concerned.

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