3.1.

The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the measuring 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, the technical documentation, as described in Article 18, for one model of each category of measuring instruments intended to be manufactured. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, 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 instrument, the documentation concerning the quality system, and a written declaration that the same application has not been lodged with any other notified body.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.