Annex VI of machines directive 1998/37/EC

ANNEX VI : EC TYPE-EXAMINATION

For the purposes of this Annex, 'machinery` means either 'machinery` or 'safety component` as defined in Article 1(2).

1. EC type-examination is the procedure by which a notified body ascertains and certifies that an example of machinery satisfies the provisions of this Directive which apply to it.

2. The application for EC type-examination shall be lodged by the manufacturer or by his authorised representative established in the Community, with a single notified body in respect of an example of the machinery.

The application shall include:

- the name and address of the manufacturer or his authorised representative established in the Community and the place of manufacture of the machinery,

- a technical file comprising at least:

- an overall drawing of the machinery together with drawings of the control circuits,

- full detailed drawings, accompanied by any calculation notes, test results, etc., required to check the conformity of the machinery with the essential health and safety requirements,

- a description of methods adopted to eliminate hazards presented by the machinery and a list of standards used,

- a copy of the instructions for the machinery,

- for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.

It shall be accompanied by a machine representative of the production planned or, where appropriate, a statement of where the machine may be examined.

The documentation referred to above does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the basic safety requirements.

3. The notified body shall carry out the EC type-examination in the manner described below:

- it shall examine the technical construction file to verify its appropriateness and the machine supplied or made available to it,

- during the examination of the machine, the body shall:

(a) ensure that it has been manufactured in conformity with the technical construction file and may safely be used under its intended working conditions;

(b) check that standards, if used, have been properly applied;

(c) perform appropriate examinations and tests to check that the machine complies with the essential health and safety requirements applicable to it.

4. If the example complies with the provisions applicable to it the body shall draw up an EC type-examination certificate which shall be forwarded to the applicant. That certificate shall state the conclusions of the examination, indicate any conditions to which its issue may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved example.

The Commission, the Member States and the other approved bodies may obtain a copy of the certificate and, on a reasoned request, a copy of the technical construction file and of the reports on the examinations and tests carried out.

5. The manufacturer or his authorised representative established in the Community shall inform the notified body of any modifications, even of a minor nature, which he has made or plans to make to the machine to which the example relates. The notified body shall examine those modifications and inform the manufacturer or his authorised representative established in the Community whether the EC type-examination certificate remains valid.

6. A body which refuses to issue an EC type-examination certificate shall so inform the other notified bodies. A body which withdraws an EC type-examination certificate shall so inform the Member State which notified it. The latter shall inform the other Member States and the Commission thereof, giving the reasons for the decision.

7. The files and correspondence referring to the EC type-examination procedures shall be drawn up in an official language of the Member State where the notified body is established or in a language acceptable to it.