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anx_VIII__cpt_1__cpt_3__cpt_1

3.1. The manufacturer shall lodge an application for assessment of his quality system 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; the address of the manufacturer's premises where the audits can be carried out; a written declaration that the same application has not been lodged with any other notified body; the identification of the PPE concerned; the documentation concerning the quality system. Where the chosen body is not the body that has carried out the EU type-examination, the application shall also include the following: the technical documentation of the PPE described in Annex III; a copy of the EU type-examination certificate.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-01 · Text as adopted (Official Journal); later amendments are not incorporated in this text.