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.
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.
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 Member 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 Member 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 EU instrument 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
11. A manufacturer must keep the technical documentation and the EU 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.
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.
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.
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.
(2) Where it is not possible to provide the information referred to in paragraph (1) on the product that information must be provided—
(a)on the packaging;
(b)or in a document accompanying the product.
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 Member 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 the United Kingdom, that language which can be easily understood is English.
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 Member 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.
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.