Module F1

Module F1

Conformity based on product verification

Conformity based on product verification is a conformity assessment procedure whereby the manufacturer fulfills the obligations set out in Sections 2, 3, 6.1, and 7 and, under its sole responsibility, ensures and declares that the products concerned, which have been subject to the provisions of Section 4, are in conformity with the requirements of the applicable legal instrument.

Technical Documentation

The manufacturer shall draw up technical documentation. The documentation shall enable the assessment of the product’s conformity with the applicable requirements and shall include an adequate analysis and assessment of risks. The technical documentation shall specify the applicable requirements and, to the extent necessary for the assessment, cover the design, manufacture, and operation of the product. The technical documentation must contain, where relevant, 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 carried out, etc.,

— test reports.

The manufacturer shall keep the technical documentation at the disposal of the competent national authorities for a period of ten years after the product has been placed on the market.

3.	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 relevant requirements of the legal instrument.

Verification

The notified body chosen by the manufacturer shall carry out appropriate examinations and tests to verify the conformity of the products with the relevant requirements of the legislative instrument.

The examinations and tests to verify compliance with these requirements shall be carried out, at the manufacturer’s choice, either by examination and testing of every product in accordance with point 5, or by examination and testing of products on a statistical basis in accordance with point 6.

Verification of Conformity by Examination and Testing of Each Product

5.1

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 requirements applicable to them. If no such harmonized standard or technical specification exists, the notified body concerned shall decide which appropriate tests are to be carried out.

5.2

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 a period of ten years after the product has been placed on the market.

Statistical verification of conformity

6.1	The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the homogeneity of each batch produced and shall present its products for verification in the form of homogeneous batches.

6.2

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 forth in the relevant harmonized standards or technical specifications, or equivalent tests, shall be carried out to determine whether the products comply with the applicable requirements and to decide whether the batch is accepted or rejected. If no such harmonized standard or technical specification exists, the notified body concerned shall decide which appropriate tests are to be carried out.

6.3

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 manufacturer shall keep the certificates of conformity at the disposal of the national authorities for a period of ten years after the product has been placed on the market.

If a batch is rejected, the notified body 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.

Conformity Marking and Declaration of Conformity

7.1

The manufacturer shall affix the conformity marking set out in the legislative instrument and, under the responsibility of the notified body referred to in point 4, the identification number of that body to each individual product that satisfies the applicable requirements of the legislative instrument.

7.2

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 specify the product model for which it was 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 5 agrees, the manufacturer may also affix the notified body’s identification number to the products under the responsibility of that body.

8.	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.

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 3 and 6.1.