3.

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 as described in Article 18. The technical documentation shall make it possible to assess the instrument’s conformity with the applicable requirements of this Directive 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 application shall in addition contain, wherever applicable: the specimens, representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme; the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards, and/or normative documents have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

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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.