第27条 製造業者の義務

1. When placing products covered by a delegated act adopted pursuant to Article 4 on the market or putting them into service, manufacturers shall ensure that:

(a)those products have been designed and manufactured in accordance with the performance requirements set out in the delegated acts adopted pursuant to Article 4;

(b)those products are accompanied by the information required under Article 7 and the delegated acts adopted pursuant to Article 4; and

(c)a digital product passport is available in accordance with Article 9 and the delegated acts adopted pursuant to Article 4, including a back-up copy of the most up-to-date version of the digital product passport stored by a digital product passport service provider in accordance with Article 10(4).

2. Before placing a product covered by a delegated act adopted pursuant to Article 4 on the market or putting it into service, manufacturers shall carry out the conformity assessment procedure specified in that delegated act, or have it carried out on their behalf, and draw up the required technical documentation.

Where compliance of a product covered by a delegated act adopted pursuant to Article 4 with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity in accordance with Article 44 and affix the CE marking in accordance with Article 46. However, where the Commission has specified alternative rules pursuant to Article 4(6), point (d), the manufacturer shall affix conformity marking in accordance with those rules.

3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after a product covered by a delegated act adopted pursuant to Article 4 has been placed on the market or put into service, unless a different period has been specified in that delegated act.

4. Manufacturers shall ensure that procedures are in place to ensure that products covered by a delegated act adopted pursuant to Article 4 which are part of a series production remain in conformity with the applicable requirements. Changes in the production process, product design or in characteristics, as well as changes in harmonised standards, common specifications or other technical specifications by reference to which product conformity is declared or through the application of which its conformity is verified, shall be adequately taken into account by manufacturers and, in the event they find that the product’s conformity is affected by such changes, manufacturers shall carry out a reassessment in accordance with the applicable conformity assessment procedure as referred to in paragraph 2, or have that reassessment carried out on their behalf.

5. Manufacturers shall ensure that their products covered by a delegated act adopted pursuant to Article 4 bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not so allow, that the required information is provided on the packaging or in a document accompanying the product.

6. For products covered by a delegated act adopted pursuant to Article 4, manufacturers shall indicate their name, registered trade name or registered trade mark, postal address at which, and electronic means of communication through which, they can be contacted:

(a)on the public part of the digital product passport, where applicable; and

(b)on the product or, where that is not possible, on its packaging, or in a document accompanying the product.

The address shall indicate a single point where the manufacturer can be contacted. The contact details shall be clear, understandable and legible.

7. Manufacturers shall ensure that a product covered by a delegated act adopted pursuant to Article 4 is accompanied by instructions in digital format concerning the product (‘digital instructions’) in a language that can be easily understood, as determined by the Member State concerned. Digital instructions shall be clear, understandable and legible and include at least the information set out in Article 7(2), point (b)(ii), as specified in that delegated act.

However, manufacturers shall provide in paper, in a concise format, safety information and the instructions relevant for the health and safety of customers and other relevant actors.

When providing the digital instructions, the manufacturer shall include them in the digital product passport and make them accessible through the corresponding data carrier, or, where the digital product passport is not applicable, indicate on the product, or, where that is not possible, on its packaging or in an accompanying document, how to access the digital instructions.

The manufacturer shall present the digital instructions in a format that makes it possible to download and save them on an electronic device so that the user can access them at all times and shall make them accessible online during the expected lifetime of the product, but in any event for at least 10 years after the placing on the market or putting into service of the product.

Where the customer so requests at the time of the purchase, or up to six months after that purchase, the manufacturer shall provide the digital instructions in a paper format, free of charge, within one month of receiving the request.

The delegated acts adopted pursuant to Article 4 may specify that certain information forming part of the digital instructions is also to be provided in paper format.

8. Manufacturers that consider or have reason to believe that a product covered by a delegated act adopted pursuant to Article 4 that they have placed on the market or put into service is not in conformity with the requirements set out in that delegated act shall without undue delay take the necessary corrective action to bring that product into conformity, or to immediately withdraw or recall it, if appropriate.

Manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available or put it into service of the suspected non-compliance and of any corrective action taken.

9. Manufacturers shall make publicly available communication channels such as a telephone number, electronic address or dedicated section of their website, taking into account the accessibility needs of persons with disabilities, in order to allow customers to submit complaints or concerns regarding the potential non-conformity of products.

Manufacturers shall keep a register of complaints and concerns as long as it is necessary for the purposes of this Regulation, but no longer than five years after they have been submitted and make the register available at the request of a market surveillance authority.

10. Manufacturers shall, for products covered by a delegated act adopted pursuant to Article 4, further to a reasoned request from a competent national authority, provide all the information and documentation necessary to demonstrate the conformity of those products, including the technical documentation, in a language that can be easily understood by that authority. That information and documentation shall be provided in paper or electronic form, as soon as possible and in any event within 15 days of receipt of a request by that authority.

Manufacturers shall cooperate with the competent national authority regarding any corrective action taken to remedy any case of non-compliance with the requirements set out in the applicable delegated act adopted pursuant to Article 4.