Regulation (EU) 2016/424 of the European Parliament and of the CouncilShow full title

CHAPTER II U.K. OBLIGATIONS OF ECONOMIC OPERATORS

Article 11 U.K. Obligations of manufacturers

1. When placing their subsystems or safety components on the market or when incorporating them into a cableway installation, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex II.

2. Manufacturers of subsystems or safety components shall draw up the technical documentation set out in Annex VIII (‘technical documentation’) and carry out the relevant conformity assessment procedure referred to in Article 18 or have it carried out.

Where compliance of a subsystem or a safety component with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, 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 30 years after the subsystem or the safety component has been placed on the market.

4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Regulation. Changes in subsystem or safety component design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the subsystem or the safety component is declared shall be adequately taken into account.

When deemed appropriate with regard to the risks presented by a subsystem or a safety component, manufacturers shall, to protect the health and safety of passengers, operating personnel and third parties, carry out sample testing of subsystems or safety components made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming subsystems and safety components and recalls of such subsystems and safety components, and shall keep distributors informed of any such monitoring.

5. Manufacturers shall ensure that subsystems or safety components which they have placed on the market bear a type, batch or serial number or other element allowing their identification.

Where the size or nature of the subsystem or safety component does not allow it, manufacturers shall ensure that the required information is provided on the packaging or in a document accompanying the subsystem or safety component.

6. Manufacturers shall indicate on the subsystem or the safety component 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 the packaging or in a document accompanying the subsystem or safety component. 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 users and the market surveillance authorities. Where the manufacturer indicates a website address, he shall ensure that the information on that website is accessible and kept updated.

7. Manufacturers shall ensure that the subsystem or the safety component is accompanied by a copy of the EU declaration of conformity and by instructions and safety information, in a language which can be easily understood by users, as determined by the Member State concerned. Such instructions and safety information shall be clear, understandable and intelligible.

However, where a large number of subsystems or safety components are delivered to a single economic operator or user, the batch or consignment concerned may be accompanied by a single copy of the EU declaration of conformity.

8. Manufacturers who consider or have reason to believe that a subsystem or a safety component which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that subsystem or safety component into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the subsystem or the safety component presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the subsystem or the safety component 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 necessary to demonstrate the conformity of the subsystem or the safety component with this Regulation, in a language which can be easily understood by that authority. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by subsystems or safety components which they have placed on the market.

Article 12 U.K. Authorised representatives

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

The obligations laid down in Article 11(1) and the obligation to draw up 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 national market surveillance authorities for 30 years after the subsystem or the safety component 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 subsystem or the safety component;

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

Article 13 U.K. Obligations of importers

1. Importers shall place only compliant subsystems or safety components on the market.

2. Before placing on the market a subsystem or a safety component, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 18 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the subsystem or the safety component bears the CE marking and that it is accompanied by a copy of the EU declaration of conformity, by instructions and safety information, and, where appropriate, by other required documents, and that the manufacturer has complied with the requirements set out in Article 11(5) and (6).

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

3. Importers shall indicate on the subsystem or the safety component 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 subsystem or safety component. The contact details shall be in a language easily understood by users and market surveillance authorities.

Where the importer indicates a website address, he shall ensure that the information on that website is accessible and kept updated.

4. Importers shall ensure that the subsystem or the safety component is accompanied by instructions and safety information, in a language which can be easily understood by users, as determined by the Member State concerned.

5. Importers shall ensure that, while a subsystem or a safety component is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable essential requirements set out in Annex II.

6. When deemed appropriate with regard to the risks presented by a subsystem or a safety component, importers shall, to protect the health and safety of the passengers, operating personnel and third parties, carry out sample testing of subsystems or safety components made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming subsystems and safety components and recalls of such subsystems and safety components, and shall keep distributors informed of any such monitoring.

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

8. Importers shall, for 30 years after the subsystem or the safety component 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.

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 subsystem or a safety component, in a language which can be easily understood by that authority. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by subsystems or safety components which they have placed on the market.

Article 14 U.K. Obligations of distributors

1. When making a subsystem or a safety component available on the market, distributors shall act with due care in relation to the requirements of this Regulation.

2. Before making a subsystem or a safety component available on the market, distributors shall verify that the subsystem or the safety component bears the CE marking and that it is accompanied by a copy of the EU declaration of conformity, by instructions and safety information, and, where appropriate, by other required documents, in a language which can be easily understood by users as determined by the Member State concerned, and that the manufacturer and the importer have complied with the requirements set out in Article 11(5) and (6) and Article 13(3) respectively.

Where a distributor considers or has reason to believe that a subsystem or a safety component is not in conformity with the applicable essential requirements set out in Annex II, he shall not make the subsystem or the safety component available on the market until it has been brought into conformity. Furthermore, where the subsystem or the safety component 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 a subsystem or a safety component is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable essential requirements set out in Annex II.

4. Distributors who consider or have reason to believe that a subsystem or a safety component which they have made available on the market is not in conformity with this Regulation shall make sure that the corrective measures necessary to bring that subsystem or safety component into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the subsystem or the safety component presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the subsystem or the safety component 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 necessary to demonstrate the conformity of a subsystem or a safety component. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by subsystems or safety components which they have made available on the market.

Article 15 U.K. 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 Regulation and shall be subject to the obligations of the manufacturer under Article 11, where he places a subsystem or a safety component on the market under his name or trade mark or modifies a subsystem or a safety component already placed on the market in such a way that compliance with the requirements of this Regulation may be affected.

Article 16 U.K. 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 a subsystem or a safety component;

(b)

any economic operator and any person responsible for a cableway installation to whom they have supplied a subsystem or a safety component.

Economic operators shall be able to present the information referred to in the first paragraph for 30 years after they have been supplied with the subsystem or the safety component and for 30 years after they have supplied the subsystem or the safety component.