Annex X — Conformity based on unit verification

(Module G)¶

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 its sole responsibility that the machinery or related product, which is subject to point 4, is in conformity with the essential health and safety requirements set out in Annex III.

2. Technical documentation¶

The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 4. The documentation shall make it possible to assess the machinery or related product’s conformity with the relevant essential health and safety requirements set out in Annex III, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable essential health and safety requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the machinery or related product.

The technical documentation shall, wherever applicable, contain at least the following elements:

(a) the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of that authorised representative;

(b) the technical documentation for the unit of machinery or related products intended to be manufactured.

In addition, the technical documentation shall, wherever applicable, contain at least:

(i) the elements set out in points (a) to (g) of Annex IV, Part A;

(ii) the documentation concerning the quality system; and

(iii) a written declaration that the same application has not been lodged with any other notified body.

(2.1) The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for at least 10 years after the machinery or related product has been placed on the market.

3. Manufacturing¶

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured machinery or related product with the applicable essential health and safety requirements set out in Annex III.

4. Verification¶

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or common specifications, or equivalent tests, to check the conformity of the machinery or related product with the applicable essential health and safety requirements set out in Annex III, or have them carried out. In the absence of such a harmonised standard and/or common specification the notified body concerned shall decide on the appropriate tests to be carried out.

The notified body shall issue a certificate in respect of the examinations and tests carried out and shall affix its identification number to the approved machinery or related product, or have it affixed under its responsibility.

The manufacturer shall keep the certificates at the disposal of the national authorities for at least 10 years after the machinery or related product has been placed on the market.

5. CE marking and EU declaration of conformity¶

(5.1) The manufacturer shall affix the required CE marking set out in Article 10(2) and, under the responsibility of the notified body referred to in point 4, that body’s identification number, to the machinery or related product that satisfies the applicable essential health and safety requirements set out in Annex III.

(5.2) The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for at least 10 years after the machinery or related product has been placed on the market or put into service. The EU declaration of conformity shall identify the machinery or related product 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.

6. Authorised representative¶

The manufacturer’s obligations set out in points 2.1 and 5 may be fulfilled by its authorised representative, acting on its behalf and under its responsibility, provided that those obligations are specified in the mandate.