Regulation (EU) 2016/424 of the European Parliament and of the CouncilDangos y teitl llawn

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 [F1 a declaration of conformity] and affix the [F2 UK marking].

3. Manufacturers shall keep the technical documentation and [F3 the 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 [F4 English]. 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 [F3 the declaration of conformity] and by instructions and safety information, in [F5 English]. 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 [F3 the 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 [F6 Executive] 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 [F7 the Executive], provide it with all the information and documentation necessary to demonstrate the conformity of the subsystem or the safety component with this Regulation, in [F8 English]. 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.

Textual Amendments

F1 Words in Art. 11(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 21(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 11(2) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 21(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 11 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 21(a); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in Art. 11(6) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 21(c); 2020 c. 1, Sch. 5 para. 1(1)

F5 Word in Art. 11(7) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 21(d); 2020 c. 1, Sch. 5 para. 1(1)

F6 Word in Art. 11(8) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 21(e); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 11(9) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 21(f)(i); 2020 c. 1, Sch. 5 para. 1(1)

F8 Word in Art. 11(9) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 21(f)(ii); 2020 c. 1, Sch. 5 para. 1(1)