S.L. 427.64 Art. 6Conformity assessment.

(1) Before placing a product covered by implementing measures on the market or putting such a product into service, the manufacturer or its authorised representative shall ensure that an assessment of the product’s conformity with all the relevant requirements of the applicable implementing measure is carried out.

(2) (a) The conformity assessment procedures shall be specified by the corresponding implementing measures.

(b) Implementing measures may refer to the following conformity assessment modules:

(i) the internal design control set out in Schedule IV, and the management system set out in Schedule V; or

(ii) a module described in Annex II to Decision 768/ * 2008/EC .

(c) Where the Director of Market Surveillance has strong indications of probable non-compliance of a product, he shall immediately inform the Directorate who shall as soon as possible publish a substantiated assessment of the product’s compliance which may be conducted by a notified body, in order to allow, if appropriate, timely corrective action, if any.

(d) Where a product covered by implementing measures is designed by an organisation registered in accordance with Regulation (EC) No. 761/2001 of the European Parliament and of the Council of 19th March 2001 allowing voluntary participation by organisations in a Community Eco Management and Audit Scheme †

(EMAS) and the design function is included within the scope of that registration, the management system of that organisation shall be presumed to comply with the requirements of Schedule V.

(e) If a product covered by implementing measures is designed by an organisation having a management system which includes the product design function and which is implemented in accordance with harmonised standards the reference numbers of which have been published in the OJ, that management system shall be presumed to comply with the corresponding requirements of Schedule V.

(3) (a) After placing a product covered by implementing measures on the market or putting it into service, the manufacturer or its authorised representative shall keep relevant documents relating to the conformity assessment performed and declarations of conformity issued available for inspection for a period of ten years after the last of that product has been manufactured.

(b) The relevant documents shall be made available within ten days upon receipt of a request by the Director of Market Surveillance.

(4) Documents relating to the conformity assessment and declaration of conformity referred to in regulation 5 shall be drawn up in one of the official languages of the institutions of the European Union.

*O.J. No. L 218, 13-08-2008, p 82 †O.J. No. L 114, 24-04-2001, p 1