Pursuant to the applicable regulations, a manufacturer is any natural or legal person that places a product on the market or puts a product into service under its own name or mark (brand).
This also applies to folding, packing, processing or labeling finished products for placing on the market under your own brand.
The manufacturer assumes full and final responsibility for his product. When a product is manufactured by subcontractors, the manufacturer must maintain control over the entire production process, as he is responsible for the compliance of the product with essential or other requirements. Ordering some or all of the work does not release the manufacturer from product liability.
During the design and production phase, the manufacturer is responsible, inter alia, for:
- Ensuring the compliance of the product with the essential or other requirements,
- If required by the directive - involvement in the conformity assessment of an independent body with appropriate authorization to carry out product testing or assessment and approval of the quality system (the so-called notified body),
- Preparation of technical documentation,
- Affixing the CE marking on the goods,
- Drawing up a declaration of conformity.
All products covered by the provisions transposing the New Approach directives into Polish law are subject to conformity assessment with essential or other requirements before they are placed on the market.
Conformity assessment procedures vary depending on the specific product. For many products, conformity assessment is very simple, but devices with a complex design, the use of which may be associated with a greater risk to the life or health of consumers, undergo a more complex procedure.
One of the basic obligations of the manufacturer is to prepare technical documentation for the product. This documentation should contain information about the design, method of manufacture and operation. As a rule, such documentation must be kept for at least ten years after the last unit of the product has been manufactured.
The manufacturer is also responsible for drawing up a declaration of conformity in which he declares on his own responsibility that his product conforms to the essential or other requirements. The provisions introducing individual directives to Polish law define the information that should be included in the declaration of conformity. The declaration must be made available to market surveillance authorities upon request, and some directives require it to be attached to the product.
A positive result of the conformity assessment with the essential or other requirements entitles the manufacturer to affix the CE symbol to the product.