MODULE G: CONFORMITY BASED ON UNIT VERIFICATION

1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5 and ensures and declares on his sole responsibility that the instrument concerned, which has been subject to the provisions of point 4, is in conformity with the requirements of this Directive that apply to it. The manufacturer shall establish the technical documentation as described in Article 18 and make it available to the notified body referred to in point 4. 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 manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 10 years after the instrument has been placed on the market. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instrument with the applicable requirements of this Directive. A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests set out in the relevant harmonised standards, and/or normative documents, or equivalent tests set out in other relevant technical specifications, to verify the conformity of the instrument with the applicable requirements of this Directive, or have them carried out. In the absence of such a harmonised standard, or normative document, the notified body concerned shall decide on the appropriate tests to be carried out. The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and affix its identification number to the approved instrument, or have it affixed under its responsibility. The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in this Directive and, under the responsibility of the notified body referred to in point 4, the latter’s identification number to each instrument that satisfies the applicable requirements of this Directive. The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. A copy of the EU declaration of conformity shall be supplied with the measuring instrument. The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

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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.