3.5.1.
The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the instruments concerned. 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; all relevant information for the instrument category envisaged; the documentation concerning the quality system; the technical documentation referred to in point 3.2.
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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.