Manufacturer, importer, distributor: the roles and obligations to the CE marking

Manufacturer, importer, distributor: the roles and obligations to the CE marking

The certification CE is an indispensable element in the marketing of certain types of products on the European market.
The CE mark guarantees consumers the conformity of the product with all the provisions of the European Community, in terms of health protection, safety and environmental protection.

As highlighted in the decision of the European Parliament and of the Council n. 768/2008/THIS, CE marking "It is the visible consequence of a whole process comprising conformity assessment in a broad sense".
This process, governed by Decision No 768/2008/EC, It presents a series of specific requirements on economic operators involved.

To get to the heart of the tasks of the various economic operators, The following figures have been identified: manufacturer, authorized representative, importer and distributor; or persons involved in the production, the entry and distribution of the product on the market.

At a general level, CE certification of products is to be counted among the manufacturer's duties, but there are several implications involving firsthand the figures importer and distributor.

The manufacturer and its obligations

This is the person, natural or legal, which manufactures the product or materially and commissioned the design and manufacture, marketing it under his name or trademark.

This figure has the obligation to draw, or to prepare a competent laboratory, come Sicom Testing, the evaluation procedure of conformity, making sure that it is consistent with the requirements of European Union directives.
It will draw up, or to prepare, the EC declaration of conformity, preparing a technical file for CE marking containing the documents attesting the full compliance of the object with the applicable regulations.

This technical file must be prepared before the placing on the market of the object and stored for 10 years.

It's’ obligation for the manufacturer affix the CE mark, which should be visible, legibly and indelibly, and the development of corrective action when noticing that the product placed on the market does not comply with the directives of the European Communities.

The manufacturer's authorized representative

As explained in Decision No. 768/2008/EC of the European Parliament and of the Council, The manufacturer is allowed to nominate, by written mandate, an authorized representative.

This is in charge of maintaining relations with national competent authorities, representing the manufacturer in the act to preserve, and make available, The EC declaration of conformity and the technical documentation, exposing them promptly following a reasoned request.

The Authorized Representative is responsible to cooperate with the national authorities in all those actions that go to solve compliance risks the products included in its mandate of representation.


The importer's figure and its obligations

The European Community has established that the importer is the person, natural or legal, that enter the EU market a product from a third country.

The importer has to verify that the product which it has imported:
• is equipped with Certificate of Conformity;
• has the CE mark visible, legibly and indelibly;
• have documentation of traceability;
• meets any specific warnings.
When the importer has reason to believe that the product does not comply should not put it on the market as long as it has not been complied with.

The importer must ensure that, the period of time when the product is under its responsibility, will not be amended so that it can jeopardize its compliance.
The importer is subject to duty to identify, bringing their data - name, address, registered trade name or trademark - the object or, should it not be possible, in an accompanying document or packaging of the product itself.

Finally, just as in the case of the manufacturer, the importer has the obligation to keep the technical documentation per 10 years of placing the product on the market and to inform the manufacturer and the supervisory authorities whenever there are emerging risk factors that could cause damage of product compliance.

The distributor and its obligations

It is the natural or legal person - different from the manufacturer or the importer - distributing a product on the market.
Among its obligations to ensure we can count, as in the case of the importer, of the product compliance with European Union directives, as for the CE marking, indications concerning the traceability and warnings, ensuring Knowledge of the technical documentation connected to the product.
The distributor is also obliged to ensure that, in the time frame in which the product is under his responsibility, this will not be exposed to risks that may compromise compliance.
It's’ Finally, you must know that the distributor recognizing non-compliant products and to work to report the inconsistencies.

An important case, it should be emphasized, is that concerning an importer or a distributor which is marketing a product under his own name or trademark. In this eventuality, indeed, the persons in question are considered by the law like a manufacturer and must fulfill all obligations related to his figure.

Sicom Testing It offers a complete service for certification CE products.

To request more information on this topic, write to
or call +39 0481 778931.

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6 thoughts on “Manufacturer, importer, distributor: the roles and obligations to the CE marking”

  1. Good morning,
    if a Chinese product has already been imported by another European company (for example German) I can buy it from the same Chinese factory and import it from China and distribute it in Italy?
    Thank you

    • Good morning.
      No, if you do not certify the product.
      Each company is responsible for what matters and places on the market. So in this case you will have to certify the product and ensure that each piece that puts it into circulation is also compliant through sample checks on the lots it receives.
      The other importing company must do the same for the pieces imported by it.
      Greetings from Sicom Testing

    • Good morning,
      the manufacturer is obliged to place only safe products on the market, following the appropriate assessments to verify that the product complies with the requirements of the applicable European directives. The manufacturer must also draw up the technical manufacturing file and affix the CE mark on the marketed product.
      The distributor must not supply products of which he knows or should have known the danger based on the information in his possession. To do this, the distributor is required to ensure the conformity of the products, check the presence of the CE mark and the technical file; the distributor should also be able to recognize any non-conformities and transmit the information to the manufacturer and the competent supervisory authorities.
      Greetings from Sicom Testing

  2. Good morning, the retailer must have the entire technical file supplied or it is sufficient for the manufacturer to issue the EC declaration? We retailers then draw up our declaration on the basis of that EC declaration that we attach to the product during the sale phase…

    • Good morning,
      the dealer (distributor) is not required to have the technical file, however, he must ascertain the conformity of the products he intends to market and verify the presence of the CE mark.
      In the event that the retailer places a product on the market under its own name and brand, is subject to the same obligations as the manufacturer, and therefore is required to keep the technical file and draw up the European declaration of conformity in his own name.
      Greetings from Sicom Testing

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