1.Before placing a product covered by implementing measures on the market and/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.The conformity assessment procedures shall be specified by the implementing measures and shall leave to manufacturers the choice between the internal design control set out in Annex IV to this Directive and the management system set out in Annex V to this Directive. Where duly justified and proportionate to the risk, the conformity assessment procedure shall be specified among relevant modules as described in Annex II to Decision No 768/2008/EC.
Where a Member State has strong indications of probable non-compliance of a product, that Member State shall as soon as possible publish a substantiated assessment of the product’s compliance which may be conducted by a competent body in order to allow, if appropriate, for timely corrective action.
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 19 March 2001 allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS)(1) 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 Annex V to this Directive.
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 Official Journal of the European Union, that management system shall be presumed to comply with the corresponding requirements of Annex V.
3.After placing a product covered by implementing measures on the market and/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 by Member States for a period of 10 years after the last of that product has been manufactured.
The relevant documents shall be made available within 10 days of receipt of a request by the competent authority of a Member State.
4.Documents relating to the conformity assessment and the EC declaration of conformity referred to in Article 5 shall be drawn up in one of the official languages of the institutions of the European Union.