Module F
Conformity to type based on product verification
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1.
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Conformity to type based on product verification is that part of the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in points 2, 5.1, and 6, and, under his sole responsibility, guarantees and declares that the products in question, which have been subjected to the provisions of point 3, are in conformity with the type described in the EC-type examination certificate and meet the requirements of the legislative instrument applicable to them.
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2.
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Manufacturing
The manufacturer shall take all necessary measures to ensure that the manufacturing process and its control ensure the conformity of the manufactured products with the approved type described in the EC type-examination certificate and with the requirements of the legislative instrument applicable to them.
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3.
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Verification
The notified body chosen by the manufacturer shall carry out appropriate examinations and tests to verify the conformity of the products with the approved type described in the EC type-examination certificate and with the relevant requirements of the legislative instrument.
The examinations and tests to verify the conformity of the products with the relevant requirements shall be carried out, at the manufacturer’s choice, either by examination and testing of every product as specified in point 4, or by examination and testing of the products on a statistical basis as specified in point 5.
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4.
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Verification of conformity by examination and testing of each product
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4.1
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All products shall be individually examined and appropriate tests set out in the relevant harmonized standard(s) or technical specifications, or equivalent tests, shall be carried out to verify the conformity of the products with the approved type described in the EC type-examination certificate and with the relevant requirements of the legislative instrument. If no such harmonized standard exists, the notified body concerned shall decide which appropriate tests are to be carried out.
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4.2
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The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to each approved product or have it affixed under its own responsibility.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for inspection purposes for a period of ten years after the product has been placed on the market.
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5.
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Statistical verification of conformity
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5.1
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The manufacturer shall take all necessary measures to ensure that the manufacturing process and its control ensure the homogeneity of each batch produced, and shall present its products for verification in the form of homogeneous batches.
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5.2
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A sample shall be drawn from each batch by random selection in accordance with the requirements of the legislative instrument. All products in the sample shall be individually examined and appropriate tests set out in the relevant harmonized standard(s) or technical specifications, or equivalent tests, shall be carried out to verify the conformity of these products with the relevant requirements of the legislative instrument and to determine whether the batch is accepted or rejected. If no such harmonized standard exists, the notified body concerned shall decide which appropriate tests are to be carried out.
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5.3
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If the batch is accepted, all products in the batch shall be considered approved, except for those products in the sample for which unsatisfactory test results were recorded.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to each approved product or have it affixed under its own responsibility.
The manufacturer shall keep the certificates of conformity available for the national authorities for a period of ten years after the product has been placed on the market.
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5.4
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If a batch is rejected, the notified body or the competent authority shall take appropriate measures to prevent that batch from being placed on the market. In the event of frequent rejection of batches, the notified body may suspend the statistical verification and take appropriate measures.
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6.
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Conformity marking and declaration of conformity
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6.1
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The manufacturer shall affix the required conformity marking set out in the legislative instrument and, under the responsibility of the notified body referred to in point 3, the identification number of that body to each individual product which conforms to the approved type described in the EC type-examination certificate and satisfies the applicable requirements of the legal instrument.
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6.2
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The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for a period of ten years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up.
A copy of the declaration of conformity shall be made available to the competent authorities upon request.
If the notified body referred to in point 3 agrees, the manufacturer may also affix the notified body’s identification number to the products under the responsibility of that body.
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7.
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If the notified body agrees, the manufacturer may, under the responsibility of the notified body, affix the notified body’s identification number to the products during the manufacturing process.
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8.
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Authorized Representative
The manufacturer’s obligations may be fulfilled on its behalf and under its responsibility by its authorized representative, provided they are specified in the mandate. The authorized representative may not fulfill the manufacturer’s obligations set forth in points 2 and 5.1.
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