CHAPTER III

Obligations of economic operators dealing with products

Obligations of manufacturers
Article 7
1
When placing their products on the market, manufacturers shall ensure that the products have been designed and manufactured in accordance with the applicable accessibility requirements of this Directive.
2
Manufacturers shall draw up the technical documentation in accordance with Annex IV and carry out the conformity assessment procedure set out in that Annex or have it carried out.
Where compliance of a product with the applicable accessibility requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.
3
Manufacturers shall keep the technical documentation and the EU declaration of conformity for five years after the product has been placed on the market.
4
Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive. Changes in product design or characteristics and changes in the harmonised standards, or in technical specifications, by reference to which conformity of a product is declared shall be adequately taken into account.
5
Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.
6
Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
7
Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and information, as well as any labelling, shall be clear, understandable and intelligible.
8
Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that product into conformity, or, if appropriate, to withdraw it. Furthermore, where the product does not comply with the accessibility requirements of this Directive, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. In such cases, manufacturers shall keep a register of products which do not comply with applicable accessibility requirements and of the related complaints.
9
Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products which they have placed on the market, in particular bringing the products into compliance with the applicable accessibility requirements.

Authorised representatives
Article 8
1
A manufacturer may, by a written mandate, appoint an authorised representative.
The obligations laid down in Article 7(1) and the drawing up of technical documentation shall not form part of the authorised representative’s mandate.
2
An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
a
keep the EU declaration of conformity and the technical documentation at the disposal of market surveillance authorities for five years;
b
further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product;
c
cooperate with the competent national authorities, at their request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products covered by their mandate.

Obligations of importers
Article 9
1
Importers shall place only compliant products on the market.
2
Before placing a product on the market, importers shall ensure that the conformity assessment procedure set out in Annex IV has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation required by that Annex, that the product bears the CE marking and is accompanied by the required documents and that the manufacturer has complied with the requirements set out in Article 7(5) and (6).
3
Where an importer considers or has reason to believe that a product is not in conformity with the applicable accessibility requirements of this Directive, the importer shall not place the product on the market until it has been brought into conformity. Furthermore, where the product does not comply with the applicable accessibility requirements, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
4
Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The contact details shall be in a language easily understood by end-users and market surveillance authorities.
5
Importers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.
6
Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable accessibility requirements.
7
Importers shall, for a period of five years keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and shall ensure that the technical documentation can be made available to those authorities upon request.
8
Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that product into conformity, or, if appropriate, to withdraw it. Furthermore, where the product does not comply with the applicable accessibility requirements, importers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. In such cases, importers shall keep a register of products which do not comply with applicable accessibility requirements, and of the related complaints.
9
Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products which they have placed on the market.

Obligations of distributors
Article 10
1
When making a product available on the market distributors shall act with due care in relation to the requirements of this Directive.
2
Before making a product available on the market distributors shall verify that the product bears the CE marking, that it is accompanied by the required documents and by instructions and safety information in a language which can be easily understood by consumers and other end-users in the Member State in which the product is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in Article 7(5) and (6) and Article 9(4) respectively.
3
Where a distributor considers or has reason to believe that a product is not in conformity with the applicable accessibility requirements of this Directive, the distributor shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product does not comply with the applicable accessibility requirements, the distributor shall inform the manufacturer or the importer and the market surveillance authorities to that effect.
4
Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable accessibility requirements.
5
Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with this Directive shall make sure that the corrective measures necessary to bring that product into conformity, or, if appropriate, to withdraw it, are taken. Furthermore, where the product, does not comply with the applicable accessibility requirements, distributors shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
6
Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product. They shall cooperate with that authority, at its request, on any action taken to eliminate the non-compliance with the applicable accessibility requirements of products which they have made available on the market.

Cases in which obligations of manufacturers apply to importers and distributors
Article 11
An importer or distributor shall be considered a manufacturer for the purposes of this Directive and shall be subject to the obligations of the manufacturer under Article 7, where it places a product on the market under its name or trademark or modifies a product already placed on the market in such a way that compliance with the requirements of this Directive may be affected.

Identification of economic operators dealing with products
Article 12
1
Economic operators referred to in Articles 7 to 10 shall, upon request, identify to the market surveillance authorities, the following:
a
any other economic operator who has supplied them with a product;
b
any other economic operator to whom they have supplied a product.
2
Economic operators referred to in Articles 7 to 10 shall be able to present the information referred to in paragraph 1 of this Article for a period of five years after they have been supplied with the product and for a period of five years after they have supplied the product.
3
The Commission is empowered to adopt delegated acts in accordance with Article 26 to amend this Directive in order to change the period referred to in paragraph 2 of this Article for specific products. That amended period shall be longer than five years, and shall be in proportion to the economically useful life of the product concerned.