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

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

La certificazione 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 the 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, What 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 EU 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, leggibile e indelebile, 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 EU 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, legible and indelible;
• 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 for 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 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 offers a complete service for the certificazione CE of products.

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

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152 comments on “Manufacturer, importer, distributor: the roles and obligations to the CE marking”

  1. Good afternoon
    If I make a product, I pay the royalty and deliver it to the importer at the port and in turn the importer delivers it to another brand that distributes it in the UK in its stores under its brand.
    What should appear on the label?
    Produced by…(First production company)
    Imported from the second company (importer)
    Distributed by a third company (distributor in the United Kingdom)

    • Good morning,
      Both according to European directives and according to UK regulations: An importer or distributor is deemed to be a manufacturer is subject to the obligations of the manufacturer when he places electrical equipment on the market under his name or trademark or modifies electrical equipment already placed on the market.
      Then the company that distributes the product under its own brand will be considered as a manufacturer, will be responsible for the products it sells and their compliance; Only the name of the distribution company will appear on the label, but it must be indicated as the manufacturer.
      Kind regards
      Sicom Test

  2. Good morning,
    I have a doubt. When we talk about a distributor who affixes his own brand what is meant by? Let me give you an example.: on PPE labelled by the manufacturer (and reporting the relevant information) the distributor's logo is affixed (but not on the label). The manufacturer remains the one who produced it or becomes the one who put the logo on the outside of the product?
    Thank you

    • Good morning,
      According to the directives “An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer set out in Article 8 when placing PPE on the market under its own name, or Trademark o amend PPE already placed on the market in such a way that compliance with this Regulation may be jeopardised.”
      The logo is a trademark, therefore if the distributor affixes his logo on the product he may be subject to the obligations of the manufacturer.
      Kind regards
      Sicom Test

    • Good morning,
      For any product, the manual must contain instructions for correct use, the correct installation, and the risks that the product presents; further information that must be included in the manual depends on the specific product and is indicated in the standards applicable to the same.
      Kind regards
      Sicom Test

    • Good morning,
      When the CE mark is affixed to a product, it is valid in all European Union countries. Anyone who places a device on the market under his own name or trademark is considered to be the manufacturer.
      Kind regards
      Sicom Test

  3. Hello good morningwe have
    Patented a Vending machine I wanted to understand if we having a company that carries out trade and not production. of our machines we could affix the CE marking even if nnn are the manufacturers

    • Good morning,
      Considered as a manufacturer “the natural or legal person who manufactures electrical equipment, or who has it designed or manufactured, and markets such material under its own name or trademark”.
      The manufacturer is responsible for the CE marking
      Kind regards
      Sicom Test

  4. Good morning,purchase with regular invoice,as a wholesale distributor, within the community’ European,in Italy and abroad,spare parts for telephones ,in this case display and batteries. In addition to the writing on the packaging made in china, no reference appears of the’ European importer or distributor. instead on the accessories you. How should I behave? must be integrated with a label? or is it okay so? Know’ that around the authorities’ Competent(GDF) ,ask for the presence of evidence on convection.

    • Good morning,
      According to the European directives on products, the references of the Manufacturer and the importer must be indicated, as a distributor you have the obligation to verify that this information is present.
      As distributors you have, Furthermore, the obligation to:
      -verify that the CE marking is present (if required)
      -the necessary documentation and safety instructions and information are present in a language easily understood by consumers
      -ensure that, while the equipment is under their responsibility, storage or transport conditions do not jeopardise its compliance.
      -not to place on the market equipment that you consider non-compliant and inform the authorities if this equipment presents a risk
      -provide documentation of the equipment following a reasoned request from a competent national authority.
      Kind regards
      Sicom Test

    • Good morning,
      According to the directives, importers must indicate their name, their registered trade name or registered trade mark and the postal address to which they can be contacted.
      Kind regards
      Sicom Test

  5. Hello good morning,
    I have to import from China some electronic devices that have the manufacturer's CE certifications, but they are supplied to me by a distributor of this manufacturer. I must inform the name of the manufacturer or the name of the distributor who supplies them to me on the labeling of these devices? (my agreement is only with the Chinese distributor), I will resell these products in Spain.

    • Good morning,
      The name must be indicated on the product or packaging, the registered trade name or their registered trade mark and the postal address of the manufacturer (who issued the European declaration of conformity), and the importer (in this case your data).
      Kind regards
      Sicom Test

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