The Merchant Shipping (Marine Equipment) Regulations 2016

PART 3 EU Conformity Assessment Procedures

Applications for grant of EU conformity approval

11.—(1) Subject to paragraph (2), for equipment listed in Annex 1 of Merchant Shipping Notice MSN 1874, the manufacturer must apply to a notified body for EU conformity approval in accordance with the procedures set out in Annex II of the Directive.

(2) A manufacturer must not apply under paragraph (1) where an application for an EU conformity assessment has been made (whether by that manufacturer or another), in respect of that type of equipment, under these Regulations or in another member State, and that application has not been withdrawn.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 Annex II of the Directive.

Grant of EU conformity approval: obligations of a notified body

12.—(1) A notified body must—

(a) decide whether to grant or refuse EU conformity approval in accordance with the provisions of Annex II of the Directive; and

(b) produce an evaluation report recording the activities undertaken to reach a decision on an application made under Module B of Annex II of the Directive.

(2) Where a notified body grants EU conformity approval, it must—

(a) for the type approval of equipment under Module B of Annex II of the Directive, issue a certificate containing the information specified in paragraph 6 of that module;

(b) for approval of a quality system under Module D or E of Annex II of the Directive, 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 Module F or G of Annex II of the Directive, issue a certificate of conformity for that product.

(3) Where a notified body refuses EU conformity approval, it must notify the manufacturer, giving detailed reasons for its decision.

(4) A notified 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 a notified body knows or has reason to believe that—

(a) equipment to which it has granted EU 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),

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 EU conformity approval, a notified body must comply with the notification and provision of information requirements in article 24 and Annex II of the Directive.

Amendments to EU conformity approval

13.—(1) The manufacturer of equipment granted an EU type approval certificate by a notified 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 notified 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 notified body must determine whether an amendment to the conformity approval certificate or to the approval of the quality system is required and notify the manufacturer accordingly.

(4) Where an amendment to the 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 notified body.

Declarations of conformity

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

(2) The declaration of conformity must be in the form specified in Annex III of Decision 768/2008/EC(1).

(3) The manufacturer must provide a copy of the declaration of conformity, in one or more languages required by the flag state administration of a member State, with the equipment and send a copy of that declaration to the notified body which granted the conformity approval certificate.

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

Affixing the conformity mark

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

(a) each item of equipment for which a declaration of conformity is required, or

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

where relevant, embed the 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 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 conformity mark must be—

(a) in the form specified in Annex I of the Directive;

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

(c) followed by—

(i) the identification number of the notified body which approved the equipment, where that body is involved in the production control phase; and

(ii) the year in which the mark was affixed.

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

(a) the notified body itself; or

(b) the manufacturer on instruction of the notified 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 EU conformity approval in accordance with modules D, E, F or G of Annex II of the Directive.

Authorised Representatives

16.—(1) Where a manufacturer is not located in the territory of at least one member State, that manufacturer must appoint in writing an authorised representative situated in the European Union.

(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).

(1)

Decision No.768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EC (OJ L218, 13.8.2008, p.82).