Module G

Module G

Conformity based on verification of each individual product

Conformity based on verification of each individual product is a conformity assessment procedure whereby the manufacturer fulfills the obligations set out in points 2, 3, and 5 and, under its sole responsibility, ensures and declares that the product in question, which has been subjected to the provisions of point 4, is in conformity with the requirements of the applicable legal instrument.

Technical Documentation

The manufacturer shall draw up the technical documentation and make it available to the notified body referred to in point 4. 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 product with the relevant requirements of the legislative instrument.

Verification

The notified body chosen by the manufacturer shall carry out or have carried out the appropriate examinations and tests set out in the relevant harmonized standards or technical specifications, or equivalent tests, to verify the conformity of the product with the relevant requirements of the legislative instrument. If no such harmonized standard or technical specification exists, the notified body concerned shall decide which appropriate tests are to be carried out.

The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall, under its own responsibility, affix its identification number to the approved product or have it affixed.

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.

Conformity marking and declaration of conformity

5.1	The manufacturer shall affix the required conformity marking set out in the legal instrument and, under the responsibility of the notified body referred to in point 4, the identification number of that body to each product that meets the relevant requirements of the legal instrument.

5.2

The manufacturer shall draw up a written declaration of conformity and keep it at the disposal of the national authorities for a period of ten years from the date the product was placed on the market. The declaration of conformity shall identify the product for which it was drawn up.

A copy of the declaration of conformity shall be made available to the competent authorities upon request.

6.	Authorized Representative The manufacturer’s obligations set out in points 2 and 5 may be fulfilled on his behalf and under his responsibility by his authorized representative, provided they are specified in the mandate.