What are the names of these roles, how are they determined, and what are their rights and obligations arising from a particular role?

Manufacturer

• A manufacturer is a natural or legal person who manufactures a product or has it designed or manufactured and marks it under his name or trademark.
• The manufacturer is responsible for assessing the conformity of the product and is subject to several obligations, including traceability requirements.
• When placing a product on the EU market, the obligations of the manufacturer are the same regardless of whether he is established in a third country or in one of the Member States.

The manufacturer can design and manufacture the product himself. However, he may also have the product designed, manufactured, assembled, packaged, processed or labelled with the intention of placing it on the market under his own name or trademark and thus acting as its manufacturer. In the case of subcontracting, the manufacturer must retain overall control of the product and ensure that he receives all the information necessary to comply with his obligations under the relevant regulations.

The manufacturer has the ultimate responsibility for the conformity of the product with the applicable EU harmonization legislation, whether he has designed and manufactured the product himself or is the manufacturer because the product is placed on the market under his name or trademark.

Authorized representative

Regardless of whether the manufacturer is established in the EU or not, he may appoint an authorized representative in the EU to act on his behalf in the performance of certain tasks.

A manufacturer established outside the European Union do not need to have an authorized representative.

For the purposes of EU harmonization legislation, the authorized representative must be established in the EU to act on behalf of the manufacturer. An authorized representative within the meaning of EU harmonization legislation should not be confused with a manufacturer's commercial representative (such as authorized distributors or representatives).

Importer

• An importer is a natural or legal person established in the EU who places a product from a third country on the EU market.
• Its obligations shall be linked to those of the manufacturer.

The importer must guarantee that the manufacturer has duly fulfilled his obligations. The importer is not merely a downstream seller of the products but plays a key role in ensuring the conformity of the imported products.

The importer may be interested in acting on behalf of the manufacturer in administrative matters. In this case, he must be explicitly designated by the manufacturer and become an authorized representative.

Distributor

• A distributor is a natural or legal person in the supply chain, other than the manufacturer or the importer, who makes the product available on the market.
• Distributors are subject to specific obligations and play a key role in market surveillance.

A distributor acquires products for further distribution either from the manufacturer or from the importer or from another distributor.

In the case of products from third countries, the conformity assessment, drawing up and keeping of the EU declaration of conformity and the technical documentation remain the responsibility of the manufacturer and/or importer.

The distributor must be able to identify the manufacturer, his authorized representative, the importer or the person who supplied him with the product.

The distributor shall not supply products which, based on the information in his possession and as a professional, he knows or should assume are not lawful. This obligation also applies to other actors in the supply chain.

ARMATURY Group a.s. acts within the supply chain primarily as a manufacturer and as an importer and distributor in complex supplies of valves and accessories for various projects.

For more information:

Kamil Tengler, Quality Management Director