Module B

Module B

EC type examination

1.	EC type examination is the part of the conformity assessment procedure in which a notified body examines the technical design of a product and verifies and confirms that the technical design of the product meets the requirements of the legislative instrument applicable to the product.

EC type examination may be carried out in one of the following ways:

— by examining a sample of the complete product that is representative of the intended production (production type),

— assessment of the adequacy of the product’s technical design based on a review of the technical documentation and supporting evidence in accordance with point 3, with testing of samples of one or more essential parts of the product representative of the intended production (combination of production type and design type),

— assessment of the adequacy of the product’s technical design based on a review of the technical documentation and supporting evidence in accordance with point 3, without testing of a sample (design type).

The manufacturer shall submit an application for EC type examination to a single notified body of its choice.

The application shall include:

— the name and address of the manufacturer, and, if the application is submitted by an authorized representative, also the name and address of the authorized representative,

— a written declaration that the same application has not been submitted to another notified body,

— the technical documentation. The technical documentation must enable the assessment of the product’s conformity with the relevant requirements of the legal instrument and include an appropriate analysis and assessment of risks. The technical documentation must specify the relevant requirements and, to the extent necessary for the assessment, cover the design, manufacture, and operation of the product. The technical documentation must contain, where applicable, at least the following elements:

—

— a general description of the product,

— conceptual design and manufacturing drawings and diagrams of components, subassemblies, circuits, etc.,

— descriptions and explanations necessary for understanding these drawings and diagrams and the operation of the product,

— a list of harmonized standards or other relevant technical specifications published in the Official Journal of the European Union and applied in full or in part, and a description of the solutions adopted to meet the essential requirements of the legislative instrument where such harmonized standards have not been applied; in the case of partially applied harmonized standards, the technical documentation shall specify the parts that have been applied,

— results of design calculations, tests performed, etc.,

— test reports,

— samples representative of the intended production. The notified body may request additional samples if necessary to carry out the test program,

— supporting evidence of the adequacy of the technical design solution. This supporting evidence must refer to all documents that have been used, particularly where the relevant harmonized standards or technical specifications have not been applied in full. Where necessary, the supporting evidence shall include the results of tests carried out by the manufacturer’s appropriate laboratory or by another testing laboratory on his behalf and under his responsibility.

Notified Body:

for the product:

4.1 shall examine the technical documentation and supporting evidence to assess the adequacy of the product’s technical design;

for the sample(s):

4.2 verify that the samples have been manufactured in accordance with the technical documentation and identify the elements that have been designed in accordance with the applicable provisions of the relevant harmonized standards or technical specifications, as well as the elements that have been designed without applying the relevant provisions of those standards;

4.3 carry out or have carried out appropriate examinations and tests to verify that, where the manufacturer has chosen solutions in accordance with the relevant harmonized standards or technical specifications, those standards and specifications have been applied correctly;

4.4 carry out or have carried out appropriate examinations and tests to verify that, where solutions in accordance with the relevant harmonized standards or technical specifications have not been applied, the solutions adopted by the manufacturer meet the corresponding essential requirements of the legislative instrument;

4.5 agree with the manufacturer on the location where the examinations and tests will be carried out.

The notified body shall draw up an evaluation report in which it records the activities carried out in accordance with point 4 and their results. Without prejudice to the notified body’s obligations toward the notifying authorities, the notified body shall publish the content of this report, in full or in part, only with the manufacturer’s consent.

If the type meets the requirements of the specific legal instrument applicable to the product, the notified body shall issue an EC type-examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions of validity of the certificate (if any), and the data necessary to identify the approved type. One or more annexes may be attached to the certificate.

The certificate and its annexes shall contain all relevant information necessary to assess whether the manufactured products conform to the examined type and to carry out in-service inspections.

If the type does not meet the relevant requirements of the legal instrument, the notified body shall refuse to issue an EC type-examination certificate and shall inform the applicant accordingly, giving detailed reasons for the refusal.

The notified body shall ensure that it is kept informed of any changes in the generally acknowledged state of the art that would indicate that the approved type may no longer comply with the relevant requirements of the legislative instrument, and shall determine whether such changes require further investigation. If further investigation is required, the notified body shall inform the manufacturer.

The manufacturer shall inform the notified body that holds the technical documentation relating to the EC type-examination certificate of any modifications to the approved type that may affect the conformity of the product with the essential requirements of the legislative instrument or the conditions for the validity of the certificate. Such modifications shall require additional approval in the form of an addendum to the original EC type-examination certificate.

Each notified body shall inform its notifying authorities of the EC type-examination certificates or additions thereto that it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities a list of certificates or additions thereto that it has refused, suspended, or otherwise restricted.

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

The Commission, the Member States, and the other notified bodies may, upon request, receive a copy of the EC type-examination certificates or their addenda. The Commission and the Member States may, upon request, receive a copy of the technical documentation and the results of the examinations carried out by the notified body. Until the expiry of the validity of the EC type-examination certificate, the notified body shall keep a copy of that certificate, its annexes and additions, as well as the technical documentation, including the documentation submitted by the manufacturer.

9.	The manufacturer shall keep a copy of the EC type-examination certificate, its annexes, and its addenda, together with the technical documentation, for the benefit of the national authorities for a period of ten years after the product has been placed on the market.

10.	The manufacturer’s authorized representative may submit the application referred to in point 3 and fulfill the obligations set out in points 7 and 9, provided they are specified in the mandate.