10.—(1) A manufacturer must not place EEE on the market unless the EEE complies with the requirements of regulation 3 (restriction on the use of certain hazardous substances in EEE).
(2) A manufacturer must not place EEE on the market without having complied with—
(a)regulation 11 (design and manufacture of EEE);
(b)regulation 12 (conformity assessment procedure and drawing up of technical documentation);
(c)regulation 13 (EU declaration of conformity and CE marking);
(d)regulation 17 (compliance procedures for series production); and
(e)regulation 18 (information identifying EEE and manufacturer).
11. A manufacturer must ensure that the EEE has been designed and manufactured to comply with the requirements of regulation 3.
12.—(1) A manufacturer must—
(a)draw up technical documentation; and
(b)carry out, and comply with their obligations under, the internal production control procedure,
in relation to the EEE, in line with Module A of Annex II to Decision 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products and repealing Council Decision 93/465/EEC(1).
(2) Where other applicable EU legislation or legislation giving effect to EU legislation requires the EEE to be subject to a conformity assessment procedure which is at least as stringent as that required under paragraph (1), compliance with the requirements of regulation 3 may be demonstrated within the context of that procedure and a single set of technical documentation may be drawn up.
13. Where the compliance of the EEE with the requirements of regulation 3 has been demonstrated by the procedure referred to in regulation 12, a manufacturer must—
(a)draw up an EU declaration of conformity in accordance with regulation 14; and
(b)affix the CE marking in relation to the EEE in accordance with regulation 16.
14.—(1) The EU declaration of conformity must state that it has been demonstrated that the requirements specified in Article 4 of the Directive have been met in relation to the EEE.
(2) The EU declaration of conformity must also follow the structure, and include the information, specified in Annex VI to the Directive.
(3) The manufacturer must keep up to date the EU declaration of conformity drawn up in relation to EEE.
(4) The manufacturer must translate the EU declaration of conformity into the language required by each member State on the market of which they make the EEE available.
(5) An EU declaration of conformity in relation to EEE which is made available on the market in the United Kingdom must be drawn up in or translated into English.
(6) By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for the compliance of the EEE.
15. A manufacturer must keep the technical documentation and the EU declaration of conformity for EEE available for inspection by the market surveillance authority for a period of ten years from the day on which the EEE was placed on the market.
16.—(1) The CE marking which a manufacturer must affix under regulation 13 must be affixed visibly, legibly and indelibly.
(2) The CE marking must be affixed to—
(a)the EEE; or
(b)a data plate affixed to the EEE.
(3) Where due to the nature of the EEE it is not possible or not warranted for the CE marking to be affixed in accordance with paragraph (2), the manufacturer must instead affix the CE marking to—
(a)the packaging of the EEE; and
(b)any documents that accompany the EEE.
17.—(1) A manufacturer of EEE which is manufactured by means of series production must ensure that procedures are in place to ensure that any EEE so manufactured complies with the requirements of regulation 3.
(2) In doing so, the manufacturer must take adequate account of—
(a)any changes in the design or characteristics of the EEE; and
(b)any changes to any harmonised standards or technical specifications referred to in the EU declaration of conformity drawn up in relation to the EEE.
(3) In this regulation “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process or service.
18.—(1) A manufacturer must ensure that a type, batch or serial number or other element allowing the EEE to be identified is marked—
(a)on the EEE; or
(b)where the size or nature of the EEE does not allow this, on the packaging of the EEE or in a document accompanying the EEE.
(2) A manufacturer must indicate the manufacturer’s name, registered trade name or registered trade mark and a single address at which they can be contacted—
(a)on the EEE; or
(b)where that is not possible, on the packaging of the EEE or in a document accompanying the EEE.
(3) Where other applicable EU legislation or legislation giving effect to EU legislation contains provisions for the affixing of the manufacturer’s name and address to the EEE which are at least as stringent as those set out in this regulation, the provisions of this regulation may be met by satisfying the provisions of that other legislation.
19. A manufacturer must keep a register of any EEE placed on the market that the manufacturer has manufactured, or had designed and manufactured,—
(a)in relation to which any provision of these Regulations has not been complied with; or
(b)which has been recalled,
and keep distributors informed of these matters.
20. Where a manufacturer has placed EEE on the market and has reason to believe that any provision of these Regulations has not been complied with by the manufacturer in relation to the EEE, the manufacturer must immediately—
(a)take the corrective measures which are necessary to ensure that the provision is complied with in relation to the EEE, withdraw the EEE or recall it, if appropriate; and
(b)provide the market surveillance authority and the competent national authorities of any other member States in which they made the EEE available with information about the non-compliance and any such corrective measures taken.
21.—(1) The market surveillance authority may, during the period of 10 years from the day on which EEE was placed on the market, request the manufacturer who placed EEE on the market to—
(a)provide it within such period as the authority may specify with all the information and documentation necessary to demonstrate that the provisions of these Regulations have been complied with in relation to the EEE; and
(b)co-operate with that authority on any action taken or to be taken to ensure that the provisions of these Regulations are complied with in relation to the EEE.
(2) A request under paragraph (1)(a) must be accompanied by the reasons for making the request.
(3) The manufacturer must comply with a request made under paragraph (1).
(4) The information and documentation supplied pursuant to a request under paragraph (1)(a) must be drawn up in or translated into English.
22.—(1) A manufacturer may, by written mandate, appoint a person established within the EU as their authorised representative to act on the manufacturer’s behalf in relation to specified tasks.
(2) The mandate must allow the authorised representative to do at least the following in relation to EEE covered by the mandate—
(a)perform the manufacturer’s obligations under regulation 15 (duty to keep technical documentation and EU declaration of conformity); and
(b)perform the manufacturer’s obligations under paragraph (4) of regulation 21 (cooperation with the authorities).
(3) An authorised representative may not be appointed to perform the manufacturer’s obligations under regulation 11 (design and manufacture of EEE ) or paragraph (1)(a) of regulation 12 (conformity assessment procedure and drawing up of technical documentation).
(4) An authorised representative must comply with all the duties imposed on the manufacturer in relation to each obligation under these Regulations that the representative is appointed by the mandate to perform and, accordingly—
(a)as far as those duties are concerned, references in these Regulations to the manufacturer are to be taken as including a reference to the authorised representative; and
(b)if the authorised representative contravenes or fails to comply with any of those duties, the authorised representative may be proceeded against as though the authorised representative were the manufacturer.
(5) A manufacturer who has appointed an authorised representative to perform on the manufacturer’s behalf an obligation under these Regulations remains responsible for the proper performance of that obligation.
OJ L218, 13.8.08, p 82.