PART 2U.K.PLACING PRODUCTS ON THE MARKET

MANUFACTURERSU.K.

Duty to ensure products comply with the essential requirementsU.K.

8.  Before placing a product on the market, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements.

Technical documentation and conformity assessmentU.K.

9.  Before placing a product on the market a manufacturer must—

(a)have a relevant conformity assessment procedure carried out; and

(b)draw up—

(i)the technical documentation referred to in Schedule 9; and

(ii)any other technical documentation required as part of the relevant conformity assessment procedure to demonstrate the means used by the manufacturer to ensure that the product complies with the essential requirements.

[F1Declaration of conformity and UK markingE+W+S

10.—(1) Where the conformity of a product with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the product on the market—

(a)draw up a declaration of conformity in accordance with regulation 53; and

(b)affix the UK marking in accordance with regulation 54.

(2) The declaration of conformity must follow the format set out in Schedule 4.

(3) But where a declaration of conformity relates to a partly-completed watercraft, the declaration must follow the format set out in Schedule 3.

(4) The manufacturer must keep the declaration of conformity up to date.

(5) Where a product is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.]

EU declaration of conformity and CE markingN.I.

10.—(1) Where the conformity of a product with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the product on the market—

(a)draw up the EU declaration of conformity in accordance with regulation 53 (EU declaration of conformity); and

(b)affix the CE marking to the product in accordance with regulation 54 (CE marking).

(2) The EU declaration of conformity must follow the format set out in Schedule 4 (EU Declaration of conformity), and be translated into a language required by the [F10relevant state] where the product will be made available or put into service, unless paragraph (3) applies.

(3) If an EU declaration of conformity relates to a partly completed watercraft, that declaration must follow the format set out in Schedule 3 and be translated into a language required by the [F10relevant state] where the partly completed watercraft will be made available or put into service.

(4) The manufacturer must keep the EU declaration of conformity up-to-date.

(5) Where a product is subject to more than one [F11NI Protocol obligation] requiring a declaration of conformity to be drawn up, the manufacturer must draw up a single declaration of conformity, which—

(a)identifies all of the applicable EU instruments; and

(b)includes references to the publication of those EU instruments in the Official Journal of the European Union

Duty of manufacturers to retain technical documentation and [F2EU] declaration of conformityU.K.

11.  A manufacturer must keep the technical documentation and the [F3EU] declaration of conformity drawn up in respect of a product for a period of 10 years beginning with the day on which the product is placed on the market.

Compliance procedures for series productionE+W+S

12.—(1) The manufacturer of a product which is manufactured by series production must ensure that, before placing the product on the market, procedures are in place to ensure that any product so manufactured will be in conformity with the manufacturer’s obligations under Part 2.

(2) In doing so, the manufacturer must take adequate account of—

(a)any changes in the design or characteristics of a product; and

(b)any changes in the [F4designated] standard or in another technical specification by reference to which the F5... declaration of conformity of the product was drawn up.

Compliance procedures for series productionN.I.

12.—(1) The manufacturer of a product which is manufactured by series production must ensure that, before placing the product on the market, procedures are in place to ensure that any product so manufactured will be in conformity with the manufacturer’s obligations under Part 2.

(2) In doing so, the manufacturer must take adequate account of—

(a)any changes in the design or characteristics of a product; and

(b)any changes in the harmonised standard or in another technical specification by reference to which the EU declaration of conformity of the product was drawn up.

Duty of manufacturers to ensure products are labelledU.K.

13.—(1) Before placing a product on the market, a manufacturer must indicate on the product—

(a)a type, batch or serial number; or

(b)another element which identifies the manufacturer as the manufacturer of the product;

(2) Where, in the case of a component, it is not possible to indicate the information on the component because of the size or nature of the component, the manufacturer must provide the information specified in paragraph (1)—

(a)on the packaging; or

(b)in a document accompanying the component.

Duty to provide informationU.K.

14.—(1) Before placing a product on the market, a manufacturer must ensure that the product is labelled with—

(a)the manufacturer’s name;

(b)their registered trade name or registered trade mark; and

(c)an address, which is the single point at which they can be contacted.

[F6(2) Where it is not possible to provide the information referred to in paragraph (1) on the product, the manufacturer must ensure that the information is provided—

(a)on the packaging; or

(b)in a document accompanying the product.]

Instructions and safety informationE+W+S

15.—(1) When placing a product on the market, a manufacturer must ensure that it is accompanied by instructions and safety information in [F7English].

F8(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Instructions and safety informationN.I.

15.—(1) When placing a product on the market, a manufacturer must ensure that it is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users in the [F12relevant state] in which the product is to be made available.

(2) When the product is being made available to consumers and other end-users in [F13Northern Ireland], that language which can be easily understood is English.

Duty to take action in respect of product placed on the market which is considered not to be in conformityE+W+S

16.—(1) A manufacturer who considers or has reason to believe that a product that it has placed on the market is not in conformity Part 2, must immediately take the corrective measures necessary to—

(a)bring the product into conformity;

(b)withdraw the product from the market; or

(c)recall it.

(2) Where the product presents a risk, the manufacturer must immediately inform the market surveillance authority F9... of the risk, giving details of—

(a)the reason why the product is not considered to be in conformity; and

(b)any corrective measures taken.

Duty to take action in respect of product placed on the market which is considered not to be in conformityN.I.

16.—(1) A manufacturer who considers or has reason to believe that a product that it has placed on the market is not in conformity Part 2, must immediately take the corrective measures necessary to—

(a)bring the product into conformity;

(b)withdraw the product from the market; or

(c)recall it.

(2) Where the product presents a risk, the manufacturer must immediately inform the market surveillance authority and the competent national authorities in any [F14relevant state] in which the manufacturer has made the product available on the market of the risk, giving details of—

(a)the reason why the product is not considered to be in conformity; and

(b)any corrective measures taken.

Provision of information and co-operationU.K.

17.—(1) A manufacturer must, following a reasoned request from an enforcing authority, provide it with all of the information and documentation necessary to demonstrate the conformity of the product with the requirements of this Part.

(2) The information and documentation referred to in paragraph (1) must be in a language that can be easily understood by the enforcing authority.

(3) The manufacturer must, at the request of the enforcing authority, co-operate with the authority on any action taken to eliminate the risks posed by a product that the manufacturer has placed on the market.