Regulation 10(3)(b)(ii) and (c) and (4) (Annex VIII to the ATEX Directive)
1. This module describes the procedure whereby the manufacturer or his authorised representative established in the Community, who carries out the obligations laid down in paragraph 2, ensures and declares that the equipment satisfies the requirements of the ATEX Directive applicable to it. The manufacturer or his authorised representative established in the Community shall affix the CE marking to each piece of equipment and draw up a written declaration of conformity.
2. The manufacturer shall establish the technical documentation described in paragraph 3 and he or his authorised representative established in the Community shall keep it at the disposal of the relevant national authorities for inspection purposes for a period ending at least 10 years after the last piece of equipment was manufactured.
Where neither the manufacturer nor his authorised representative is established in the Community, the obligation to keep the technical documentation available shall be the responsibility of the person who places the equipment on the market in the Community.
3. Technical documentation shall enable the conformity of the equipment with the relevant requirements of the ATEX Directive to be assessed. It shall, to the extent necessary for such assessment, cover the design, manufacture and operation of the product. It shall contain:
a general description of the equipment;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the equipment;
a list of the standards applied in full or in part, and descriptions of the solutions adopted to meet the safety aspects of the ATEX Directive where the standards have not been applied;
results of design calculations made, examinations carried out, etc.;
test reports.
4. The manufacturer or his authorised representative shall keep a copy of the declaration of conformity with the technical documentation.
5. The manufacturer shall take all measures necessary to ensure that the manufacturing process guarantees compliance of the manufactured equipment with the technical documentation referred to in paragraph 2 and with the requirements of the ATEX Directive applicable to such equipment.