Annex 6 Module B.3—Annex 6 Module B.3
>Control Description
The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.
The application shall include:
- the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
- a written declaration that the same application has not been lodged with any other notified body;
- the technical documentation, which shall make it possible to assess the product's conformity with the applicable essential requirements as set out in Section 1 of Annex I and the manufacturer's vulnerability handling processes set out in Section 2 of Annex I, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall contain, wherever applicable, at least the elements set out in Annex V;
- the supporting evidence for the adequacy of the technical design and development solutions and vulnerability handling processes. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards and/or technical specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.
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