The manufacturer or his authorised representative established within F1the European Union, who carries out the obligations laid down in point 2, ensures and declares that the products concerned satisfy the requirements of the Directive that apply to them. The manufacturer or his authorised representative established within F1the European Union shall affix the CE marking to each product and draw up a written declaration of conformity (see Annex XV). M1

The manufacturer shall establish the technical documentation described in paragraph 3 and he or his authorised representative established within F1the European Union shall keep it for a period ending at least 10 years after the last product has been manufactured at the disposal of the relevant national authorities for inspection purposes.

Where neither the manufacturer nor his authorised representative is established within F1the European Union, the obligation to keep the technical documentation available shall be the responsibility of the person who places the product on the Community market.

Technical documentation shall enable the conformity of the products with the requirements of the Directive to be assessed. It shall, as far as relevant for such assessment, cover the design, manufacture and operation of the product (see Annex XIII). M2

The manufacturer or his authorised representative shall keep a copy of the declaration of conformity with the technical documentation.

The manufacturer shall take all measures necessary in order that the manufacturing process shall ensure compliance of the manufactured products with the technical documentation referred to in point 2 and with the requirements of the Directive that apply to them.