CHAPTER II

OBLIGATIONS OF ECONOMIC OPERATORS AND PRIVATE IMPORTERS

Obligations of manufacturers
Article 7
1
When placing their products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in Article 4(1) and Annex I.
2
Manufacturers shall draw up the technical documentation in accordance with Article 25 and carry out the conformity assessment procedure applicable or have it carried out in accordance with Articles 19 to 22 and Article 24.
Where compliance of a product with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up a declaration, as referred to in Article 15 and mark and affix the CE marking, as set out in Articles 17 and 18.
3
Manufacturers shall keep the technical documentation and a copy of the declaration, as referred to in Article 15, for 10 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. Changes in product design or characteristics and changes in the harmonised standards by reference to which conformity of a product is declared shall be adequately taken into account.
When deemed appropriate with regard to the risks presented by a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of any such monitoring.
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 components 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 shall indicate a single point at which the manufacturer can be contacted.
7
Manufacturers shall ensure that the product is accompanied by instructions and safety information in the owner’s manual in a language or languages which can be easily understood by consumers and other end users, as determined by the Member State concerned.
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 necessary corrective measures to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, 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.
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 risks posed by products which they have placed on the market.

Authorised representatives
Article 8
1
A manufacturer may, by a written mandate, appoint an authorised representative.
2
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.
3
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 a copy of the declaration, as referred to in Article 15, and the technical documentation at the disposal of national surveillance authorities for 10 years after the product has been placed on the market;
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 risks posed by products covered by their mandate.

Obligations of importers
Article 9
1
Importers shall place only compliant products on the Union market.
2
Before placing a product on the market, importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall also ensure that the manufacturer has drawn up the technical documentation, that the product bears the CE marking, as referred to in Article 17, and is accompanied by the documents required in accordance in Article 15 and point 2.5 of Part A of Annex I, point 4 of Part B of Annex I and point 2 of Part C of Annex I and that the manufacturer has complied with the requirements set out in Article 7(5) and (6).
Where an importer considers or has reason to believe that a product is not in conformity with the requirements set out in Article 4(1) and Annex I, he shall not place the product on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
3
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, in the case of components where that is not possible, on the packaging or in a document accompanying the product.
4
Importers shall ensure that the product is accompanied by instructions and safety information in the owner’s manual in a language or languages which can be easily understood by consumers and other end-users, as determined by the Member State concerned.
5
Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in Article 4(1) and Annex I.
6
When deemed appropriate with regard to the risks presented by a product, importers shall, to protect the health and safety of consumers, carry out sample testing of products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of such monitoring.
7
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, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, 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.
8
Importers shall, for a period of 10 years after the product has been placed on the market, keep a copy of the declaration, as referred to in Article 15, at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.
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 risks posed by 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, as referred to in Article 17, that it is accompanied by the documents required in Article 7(7), Article 15 and point 2.5 of Part A of Annex I, point 4 of Part B of Annex I and point 2 of Part C of Annex I and by instructions and safety information in a language or languages 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(3).
Where a distributor considers or has reason to believe that a product is not in conformity with the requirements set out in Article 4(1) and Annex I, he shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the distributor shall inform the manufacturer or the importer, as well as the market surveillance authorities, to that effect.
3
Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in Article 4(1) and Annex I.
4
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, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the product presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the product available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.
5
Distributors shall, 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 the product. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by 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 he shall be subject to the obligations of the manufacturer under Article 7, where he places a product on the market under his 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.

Obligations of private importers
Article 12
1
If the manufacturer does not fulfil the responsibilities for the conformity of the product with this Directive, a private importer, before putting the product into service, shall ensure that it has been designed and manufactured in accordance with the requirements set out in Article 4(1) and Annex I and carry out or have carried out the obligations of the manufacturer set out in Article 7(2),(3),(7) and (9).
2
If the required technical documentation is not available from the manufacturer, the private importer shall have it drawn up using appropriate expertise.
3
The private importer shall ensure that the name and address of the notified body which has carried out the conformity assessment of the product is marked on the product.

Identification of economic operators
Article 13
1
Economic operators shall, on request, identify the following to the market surveillance authorities:
a
any economic operator who has supplied them with a product;
b
any economic operator to whom they have supplied a product.
Economic operators shall be able to present the information referred to in the first subparagraph for a period of 10 years after they have been supplied with the product and for a period of 10 years after they have supplied the product.
2
Private importers shall, on request, identify to the market surveillance authorities the economic operator who has supplied them with the product.
Private importers shall be able to present the information referred to in the first subparagraph for a period of 10 years after they have been supplied with the product.