附属書VII EU型式審査

1. EU type-examination is the part of a conformity assessment procedure in which a notified body examines the technical design of machinery or a related product and verifies and attests that the technical design of the machinery or related product meets the applicable requirements of this Regulation.

2. EU type-examination shall be carried out by assessment of the adequacy of the technical design of the machinery or related product through examination of the technical documentation, plus examination of a specimen of the machinery or related product that is representative of the production envisaged (production type).

The manufacturer shall lodge an application for EU type-examination with a single notified body of its choice.

The application shall include:

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

(c)the technical documentation described in Annex IV, Part A;

(d)the access to the specimen(s) of the machinery or related product representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme. For machinery or related products produced in series where each item is adapted to fit an individual user, specimens shall be provided that are representative of the range of different users, while for machinery or related products produced as a single unit to accommodate the special needs of an individual user, a basic model shall be provided.

The notified body shall:

(a)examine the technical documentation to assess the adequacy of the technical design of the machinery or related product. In conducting such an examination, Annex IV, Part A, second subparagraph, points (h) and (l), need not be taken into account;

(b)for machinery or related products produced in series where each item is adapted to fit an individual user, examine the description of the measures to assess their adequacy;

(c)verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements that have been designed in accordance with the applicable provisions of the relevant harmonised standards or common specifications adopted by the Commission in accordance with Article 20(3), as well as the elements that have been designed in accordance with other technical specifications;

(d)carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, or common specifications adopted by the Commission in accordance with Article 20(3), those have been applied correctly;

(e)carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards or common specifications adopted by the Commission in accordance with Article 20(3) have not been applied, the solutions adopted by the manufacturer, including those in other technical specifications applied, meet the corresponding essential health and safety requirements and have been applied correctly.

The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6.1.Where the type meets the applicable essential health and safety requirements, the notified body shall issue an EU type-examination certificate to the manufacturer.

The period of validity of a newly issued certificate and, where appropriate, of a renewed certificate shall not exceed five years.

6.2.The EU type-examination certificate shall contain at least the following information:

(a)the name and identification number of the notified body;

(b)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;

(c)an identification of the machinery or related product covered by the certificate (type number);

(d)a statement that the machinery or related product type complies with the applicable essential health and safety requirements;

(e)where harmonised standards or common specifications adopted by the Commission in accordance with Article 20(3) have been fully or partially applied, the references of those standards or common specifications or parts thereof;

(f)where other technical specifications have been applied, the references of those technical specifications;

(g)the date of issue, the date of expiry and, where appropriate, the date(s) of renewal;

(h)any conditions attached to the issuing of the certificate.

6.3.The EU type-examination certificate may have one or more annexes attached.

6.4.Where the type does not satisfy the applicable essential health and safety requirements, the notified body shall refuse to issue an EU type-examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

7.1.The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art, which indicate that the approved type may no longer comply with the applicable essential health and safety requirements, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

7.2.The manufacturer shall inform the notified body that holds the technical documentation relating to the EU type- examination certificate of all modifications to the approved type and of all modifications to the technical documentation that may affect the conformity of the machinery or related product with the applicable essential health and safety requirements or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate.

7.3.The manufacturer shall ensure that the machinery or related product continues to fulfil the applicable essential health and safety requirements in light of the state of the art.

7.4.The manufacturer shall ask the notified body to review the EU type-examination certificate either:

(a)in the case of a modification to the approved type referred to in point 7.2;

(b)in the case of a change in the state of the art referred to in point 7.3;

(c)at the latest, before the date of expiry of the certificate.

In the case referred to in point (c), the review may lead to a renewal of the EU type-examination certificate only when the application is submitted by the manufacturer at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU type-examination certificate. Where the manufacturer fails to comply with the deadlines mentioned above, the review may lead only to an approval in the form of an addition to the original EU type-examination certificate and the expiry date of the certificate shall be that of the original certificate.

7.5.The notified body shall examine the machinery or related product type and, where necessary in the light of the changes made, carry out the relevant tests to ensure that the approved type continues to fulfil the applicable essential health and safety requirements. If the notified body is satisfied that the approved type continues to fulfil the applicable essential health and safety requirements, it shall renew the EU type-examination certificate or issue an addition to the original EU type-examination certificate. The notified body shall ensure that the review procedure is finalised before the expiry date of the EU type-examination certificate.

7.6.Where the conditions referred to in points (a) and (b) of point 7.4 are not met, a simplified review procedure shall apply. The manufacturer shall supply the notified body with the following:

(a)its name and address and data identifying the EU type-examination certificate concerned;

(b)confirmation that there has been no modification to the approved type as referred to in point 7.2, including materials, sub-components or sub-assemblies, nor to the relevant harmonised standards or common specifications adopted by the Commission in accordance with Article 20(3) or other technical specifications applied;

(c)confirmation that there has been no change in the state of the art as referred to in point 7.3; and

(d)where not already supplied, copies of current product drawings and photographs, product marking and information;

Where the notified body has confirmed that no modification to the approved type referred to in point 7.2 and no change in the state of the art referred to in point 7.3 has occurred, the simplified review procedure shall be applied and the examinations and tests referred to in point 7.5 shall not be carried out. In that case, the notified body shall renew the EU type-examination certificate.

The costs associated with that renewal shall be proportionate to the administrative burden of the simplified procedure.

If the notified body finds that a change in the state of the art referred to in point 7.3 has occurred, the procedure set out in point 7.5 shall apply.

7.7.If, following the review, the notified body concludes that the EU type-examination certificate is no longer valid, the body shall withdraw it and the manufacturer shall cease the placing on the market of the machinery or related product concerned.

8. Each notified body shall inform its notifying authority concerning the EU type-examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EU type-examination certificates and/or any additions thereto, which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the EU type-examination certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU type-examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.

The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, for a period of five years after the expiry of the validity of that certificate.

9. The manufacturer shall keep a copy of the EU type-examination certificate, its annexes and additions, together with the technical documentation 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.

10. The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7.2, 7.4 and 9, provided that they are specified in the mandate.