The manufacturer is defined as any natural or legal person responsible for designing and producing a product with the aim to market it under its own name or business name. This also applies to assembling, packaging, processing or labelling of ready-made products with the aim to market them under the enterprise’s own name/brand.

The manufacturer takes full and final responsibility for the product. If subcontractors are hired, the manufacturer must retain control over the production process as it is him who is responsible for the conformity of the product with the essential requirements. Subcontracting part of the works does not free the manufacturer from the responsibility for the product.

In the design and production phase, the manufacturer is responsible for:

• undertaking actions to ensure that the manufacturing process guarantees the conformity of the product with the essential requirements,

• getting involved in the conformity assessment conducted by a notified body (an independent organisation which is authorised to carry our product tests or to assess and approve the quality system), if the directive so requires,

• preparation of the technical documentation,

• putting the CE marking on the product,

• preparation of the declaration of conformity.

All products covered by the regulations transposing the New Approach Directives to the Polish law are subject to the assessment of conformity with the essential requirements before they are placed on the market. The requirements serve to counteract the threats the product may generate due to its physical and chemical properties (mechanical or physical resistance, flammability, chemical or electrical properties, radioactivity, etc.). Some requirements also relate to materials which should be used to manufacture the product, as well as to the method of its construction and to the production process.

The conformity assessment procedure differs depending on the product. For many products, it is very simple, but in the case of more complex devices, the use of which may pose a greater risk to consumers’ life or health, a more complex conformity assessment procedure has been provided for.

One of the basic obligations of the manufacturer is to prepare the technical documentation of the product. It should contain information on the design, the method of production and operation. The documentation must, in principle, be kept for the minimum of ten years of the date when the last piece of the product was manufactured (for some product categories, for example refrigerators and freezers, a shorter deadline was set).

The obligations of the manufacturer also include the preparation of the declaration of conformity (except for toys, for which the declaration is optional), in which the manufacturer states, on its own responsibility, that the product conform with the essential requirements. The regulations transposing the particular directives into the Polish law indicate what information is to be contained in the declaration of conformity. The declaration must be made available to market supervisory bodies upon demand. Some of the directives also require that the declaration be attached to the product.

The positive result of the assessment of conformity entitles the manufacturer to put the CE mark on the product.

Three directives - on packages and package waste and rail interoperability - do not provide for CE marking. On the other hand, the directive on marine equipment provides a completely different conformity marking (the image of a steering wheel), which has, nevertheless, the same function.