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The Merchant Shipping (Marine Equipment) Regulations 2016

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PART 3U.K.[F1United Kingdom Conformity Assessment Procedures]

Applications for grant of [F2United Kingdom] conformity approvalU.K.

11.[F3(1) Subject to paragraph (2), for equipment listed in Annex 1 of Merchant Shipping Notice MSN 1874 Amendment 3, the manufacturer must apply to an approved body for United Kingdom conformity approval in accordance with the procedures set out in Schedule 2.]

(2) A manufacturer must not apply under paragraph (1) where an application for [F4a United Kingdom] conformity assessment has been made (whether by that manufacturer or another), in respect of that type of equipment, under these Regulations F5..., and that application has not been withdrawn.

(3) An application under paragraph (1) must be—

(a)in writing; and

(b)accompanied by the documentation required by [F6Schedule 2].

[F7Grant of United Kingdom conformity approval: obligations of an approved bodyU.K.

12.(1) An approved body must—

(a)decide whether to grant or refuse United Kingdom conformity approval in accordance with the provisions of Schedule 2; and

(b)where an application is made under Part 1 of Schedule 2 (Module B), produce an evaluation report recording the activities undertaken in accordance with paragraph 5 of that Schedule and their outcomes.

(2) Where an approved body grants United Kingdom conformity approval, it must—

(a)for the type approval of equipment under Part 1 (Module B) of Schedule 2, issue a certificate containing the information specified in paragraph 7 of that module;

(b)for approval of a quality system under Part 2 (Module D) or Part 3 (Module E) of Schedule 2, notify the manufacturer of its decision in writing, including the conclusions of the audit of the quality system and the reasons for its decision; or

(c)where verifying a product under Part 4 (Module F) or Part 5 (Module) G of Schedule 2, issue a certificate of conformity for that product.

(3) Where an approved body refuses United Kingdom conformity approval, it must notify the manufacturer, giving detailed reasons for its decision.

(4) An approved body must—

(a)periodically audit a quality system that it has approved; and

(b)provide the manufacturer with a report containing the results of the audit.

(5) Where an approved body knows or has reason to believe that—

(a)equipment to which it has granted United Kingdom conformity approval no longer complies with applicable international standards; or

(b)a manufacturer has failed to comply with an obligation under regulation 20(1) to (6) (obligations of a manufacturer),

it must require the manufacturer to take immediate corrective measures to ensure that the equipment complies with applicable international standards, and where necessary, suspend or withdraw its approval for that equipment.

(6) Following the grant of United Kingdom conformity approval, an approved body must comply with the provision of information requirements in Schedule 2 and must, in particular, inform the Secretary of State about any refusal, restriction, suspension or withdrawal of a conformity certificate and, on request, information about the conformity assessment activities performed within the scope of that approved body's designation, and any other activity performed.]

[F8Amendments to United Kingdom conformity approvalU.K.

13.(1) The manufacturer of equipment granted a United Kingdom type approval certificate by an approved body must notify that body of any changes that may affect the conformity of the equipment with applicable international standards or the conditions for validity of the certificate.

(2) The manufacturer must notify the approved body that approved a quality system under regulation 12(2)(b) of any intended changes to that system.

(3) Following receipt of a notification under paragraph (1) or (2), the approved body must determine whether an amendment to the United Kingdom conformity approval certificate or to the approval of the quality system is required and notify the manufacturer accordingly.

(4) Where an amendment to the United Kingdom conformity approval certificate or to the approval of the quality system is required, the manufacturer must apply in writing for the approval to be amended and provide such documents as requested by the approved body.]

Declarations of [F9United Kingdom] conformityU.K.

14.—(1) A manufacturer must provide a declaration of conformity with all equipment for which [F10United Kingdom] conformity approval has been granted.

[F11(2) The declaration of conformity must provide the information specified in Schedule 5.]

(3) The manufacturer must provide a copy of the declaration of [F12United Kingdom] conformity [F13in English] with the equipment and send a copy of that declaration to the [F14approved] body which granted the conformity approval certificate.

(4) The owner and master of a ship must each ensure that the declaration of [F15United Kingdom] conformity is kept with the equipment on board the ship.

Textual Amendments

Affixing the [F16United Kingdom] conformity markU.K.

15.—(1) The manufacturer must, at the end of the production stage, affix the [F17United Kingdom] conformity mark to—

(a)each item of equipment for which a declaration of [F18United Kingdom] conformity is required, or

(b)a data plate attached to that equipment, and

where relevant, embed the [F19United Kingdom] conformity mark in the equipment's software.

(2) Where it is not possible or warranted due to the nature of the item of equipment to affix the [F20United Kingdom] conformity mark in accordance with paragraph (1), it must be affixed to—

(a)the packaging of the item of equipment;

(b)a label on the item of equipment or its packaging; or

(c)a document distributed with the item of equipment.

(3) The [F21United Kingdom] conformity mark must be—

(a)in the form specified in [F22Annex 5 of MSN 1874 Amendment 3];

(b)affixed so that it is visible, legible and indelible; and

(c)followed by—

[F23(i)the identification number of the approved body which approved the equipment and the year in which the mark was affixed, where that body is involved in the production control phase; or

(ii)the identification number assigned to the United States Coast Guard by the Secretary of State, and the year in which the mark was affixed, where equipment listed in Annex 6 of Merchant Shipping Notice MSN 1874 Amendment 3 has been approved by the United States Coast Guard and granted a US declaration of conformity.]

(4) Where the number of the [F24approved] body is to be affixed under paragraph (3)(c)(i), it must be affixed by—

(a)the [F24approved] body itself; or

(b)the manufacturer on instruction of the [F24approved] body.

(5) No person may affix a mark or inscription which is likely to mislead any person with regard to the meaning or the graphics of the mark.

(6) In this regulation—

production control phase” means the phase of production during which the manufacturer ensures that each item of equipment complies with its [F25United Kingdom] conformity approval in accordance with modules D, E, F or G of [F26Schedule 2].

Textual Amendments

Authorised RepresentativesU.K.

[F2716.(1) Where a manufacturer is not located in the United Kingdom, that manufacturer may, by a written mandate, appoint an authorised representative with the mandate to include the name and contact address of the authorised representative.

(2) Where a manufacturer appoints an authorised representative, that representative must carry out the manufacturer's obligations under regulation 20(1)(c) and 22(2).]

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