EC type-examination is a process whereby a notified body ascertains and certifies that a representative sample of the production envisaged (e.g.
PPE,
machine or
safety component) conforms to the relevant essential requirements.
Procedure
Applications for EC type-examination are to be lodged by the manufacturer or his authorised representative established in the Community, with a single notified body in respect of an example of the product (e.g. PPE, machinery or safety component). The application shall include:
1) the name and address of the manufacturer or his authorised representative established in the Community and the place of manufacture of the product;
2) the manufacturer's technical file.
It shall be accompanied by the required representative example of the production planned or, where appropriate, a statement of where this may be examined.
The notified body is to:
1) examine the technical file to verify its appropriateness and the product supplied or made available to it;
2) during the examination of the product:
a) ensure that it has been manufactured in conformity with the technical 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 product complies with the essential requirements applicable to it;
d) in the case of a safety component, ensure that it is suitable for fulfilling the safety functions declared by the manufacturer. If the example complies with the provisions applicable to it, the body is to draw up an
EC type-examination certificate, which is to be forwarded to the applicant.
Other informationThe applicant is to inform the notified body of any modifications, even of a minor nature, which he has made or plans to make to the product, to which the example relates. The approved body is to examine those modifications and inform the applicant whether the EC type-examination certificate is valid for the modified product. 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 files and correspondence referring to the EC type-examination procedures are to be drawn up in an official language of the Member State where the approved body is established or in a language acceptable to it.
