Directive 2014/30/EU of the European Parliament and of the CouncilShow full title

CHAPTER 2 OBLIGATIONS OF ECONOMIC OPERATORS

Article 7 Obligations of manufacturers

1. When placing their apparatus on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex I.

2. Manufacturers shall draw up the technical documentation referred to in Annex II or Annex III and carry out the relevant conformity assessment procedure referred to in Article 14 or have it carried out.

Where compliance of apparatus with the applicable 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 10 years after the apparatus 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 apparatus design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of apparatus is declared shall be adequately taken into account.

5. Manufacturers shall ensure that apparatus which they have placed on the market bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the apparatus does not allow it, that the required information is provided on the packaging or in a document accompanying the apparatus.

6. Manufacturers shall indicate, on the apparatus, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the apparatus. The address shall 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 apparatus is accompanied by instructions and the information referred to in Article 18 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 an apparatus which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that apparatus into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the apparatus presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the apparatus available on the market 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 in paper or electronic form necessary to demonstrate the conformity of the apparatus with this Directive, 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 apparatus which they have placed on the market.

Article 8 Authorised representatives

1. A manufacturer may, by a written mandate, appoint an authorised representative.

The obligations laid down in Article 7(1) and the obligation to draw up technical documentation referred to in Article 7(2) 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 national market surveillance authorities for 10 years after the apparatus 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 the apparatus;

(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by the apparatus covered by the authorised representative’s mandate.

Article 9 Obligations of importers

1. Importers shall place only compliant apparatus on the market.

2. Before placing apparatus on the market importers shall ensure that the appropriate conformity assessment procedure referred to in Article 14 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the apparatus 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).

Where an importer considers or has reason to believe that apparatus is not in conformity with the essential requirements set out in Annex I, he shall not place the apparatus on the market until it has been brought into conformity. Furthermore, where the apparatus presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

3. Importers shall indicate on the apparatus their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the apparatus. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

4. Importers shall ensure that the apparatus is accompanied by instructions and the information referred to in Article 18 in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

5. Importers shall ensure that, while an apparatus is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements set out in Annex I.

6. Importers who consider or have reason to believe that an apparatus which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that apparatus into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the apparatus presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the apparatus available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

7. Importers shall, for 10 years after the apparatus has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

8. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form, necessary to demonstrate the conformity of apparatus 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 apparatus which they have placed on the market.

Article 10 Obligations of distributors

1. When making apparatus available on the market distributors shall act with due care in relation to the requirements of this Directive.

2. Before making apparatus available on the market distributors shall verify that the apparatus bears the CE marking, that it is accompanied by the required documents and by instructions and the information referred to in Article 18 in a language which can be easily understood by consumers and other end-users in the Member State in which the apparatus 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) respectively.

Where a distributor considers or has reason to believe that apparatus is not in conformity with the essential requirements set out in Annex I, he shall not make the apparatus available on the market until it has been brought into conformity. Furthermore, where the apparatus presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.

3. Distributors shall ensure that, while apparatus is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements set out in Annex I.

4. Distributors who consider or have reason to believe that apparatus 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 apparatus into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the apparatus presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the apparatus 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 it with all the information and documentation in paper or electronic form, necessary to demonstrate the conformity of the apparatus. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by apparatus which they have made available on the market.

Article 11 Cases in which obligations of manufacturers apply to importers and distributors

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 apparatus on the market under his name or trade mark or modifies apparatus already placed on the market in such a way that compliance with this Directive may be affected.

Article 12 Identification of economic operators

Economic operators shall, on request, identify the following to the market surveillance authorities:

(a)

any economic operator who has supplied them with apparatus;

(b)

any economic operator to whom they have supplied apparatus.

Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the apparatus and for 10 years after they have supplied the apparatus.