Manufacturer, importer, distributor: roles and obligations for CE marking

There CE certification it is an indispensable element for the marketing of certain types of products on the European market.
The CE mark guarantees the consumer the conformity of the product itself 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/EC, the CE marking “it is the visible consequence of an entire process that includes conformity assessment in a broad sense”.
This process, governed by Decision No 768/2008/EC, presents a series of specific obligations for the various 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; i.e. the subjects involved in the production, placing and distribution of the product on the market.

On a general level, the CE certification of products is to be included among the manufacturer's duties, but there are various implications that directly involve the figures of importer and distributor.

The manufacturer and his obligations

This is the person, natural or legal, who physically manufactures the product or commissions its design and manufacturing, marketing it by affixing his own brand or name.

This figure has the obligation to draw up, or have it drawn up by a competent laboratory, as Sicom Testing, the product conformity assessment procedure, verifying that it is congruent with the requirements of the European Community directives.
He will be responsible for drafting, or having drafted, the EU declaration of conformity, preparing a technical file for CE marking containing the documents that certify the full compliance of the object with current directives.

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

It is the manufacturer's obligation affix the CE mark, which must be visible, legible and indelible, as well as the implementation of corrective actions where it is discovered that the product placed on the market does not comply with European Community directives.

The authorized representative of the manufacturer

As explained in decision no. 768/2008/EC of the European Parliament and of the Council, the manufacturer is allowed to appoint, by written mandate, an authorized representative.

This figure is responsible for maintaining relations with the competent national authorities, representing the manufacturer in the act of preserving and making available the EU declaration of conformity and the technical documentation, promptly displaying them following a reasoned request.

The Authorized Representative is responsible for cooperating with the competent national authorities in all those actions that resolve the non-compliance risks of the products included in its representation mandate.

ce-marking-appliances

The figure of the importer and his obligations

The European Community has established that the importer is that person, natural or legal, who places a product originating from a third country on the community market.

The importer must verify that the product imported by him:
• is equipped with a CE Certificate of Conformity;
• has the visible, legible and indelible CE mark;
• has traceability documentation;
• meets any specific warnings.
When the importer has reason to believe that the product does not comply, he must not place it on the market until it has been conformed.

The importer must ensure that, during the period in which the product is under his responsibility, it is not modified in a way that could jeopardize its compliance.
The importer is subject to the duty to identify, reporting your data - name, address, registered trade name or registered trademark - on the object or, where this is not possible, in an accompanying document or on the 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 from the placing of the product on the market and to inform the manufacturer and the supervisory authorities where risk factors potentially detrimental to the conformity of the product arise.

The distributor and his obligations

This is the natural or legal person - different from the manufacturer and the importer - who distributes a product on the market.
Among its obligations we can include that of ensuring, as in the case of the importer, the conformity of products with European Community directives, in terms of the presence of the CE mark, indications relating to traceability and warnings, guaranteeing the knowledge of the technical documentation connected to the product.
The distributor is also obliged to guarantee that, during the period in which the product is under his responsibility, it is not exposed to risks that could compromise its conformity.
Finally, it is necessary for the distributor to know recognize non-compliant products and that it works to report inconsistencies.

An important case, which should be underlined, is that which concerns an importer or distributor who markets a product by affixing your name or trademark. In this case, in fact, the subjects in question are considered by the legislation to be the same as a manufacturer and must respond to all obligations related to their role.

Sicom Testing offers a complete service for CE certification of the products.

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

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176 thoughts on “Fabbricante, importatore, distributore: i ruoli e gli obblighi per la marcatura CE”

  1. Good morning,

    I am assembling CE certified computer parts into a computer to sell it as a whole whole computer. Since the manufacturer has already certified every part (power supply, motherboard, etc.), I need CE certification on the computer or I can legally sell the computer at retail. Thank you.

    Reply
    • Good morning,
      Compliance with the applicable directives must be verified on the finished product, so that it can be marketed on the European market.
      Depending on the type of product, different directives are applied. For example, the EMC and Low Voltage directives apply to electrical and electronic devices connected to the electricity grid. If they also have radio functionality, they fall under the radio directive which also includes the requirements of the previous ones.
      The product must be tested according to suitable harmonized standards, to demonstrate compliance with the requirements of the applicable directives.
      The product documentation and reports of the tests carried out must be collected in a technical file.
      The product declaration of conformity must be prepared and signed by the manufacturer.
      Best regards
      Sicom Test

      Reply
      • Thanks for the reply.

        So if I understand correctly, even if every single component of the system I'm building is CE certified, does the system still need to be tested?
        Who does the testing and where?

        Reply
        • Good morning,
          Yes, the complete system must be tested, Sicom Testing can carry out the conformity tests for you according to the Radio, EMC and LVD directives and prepare the technical file and the declaration of conformity.
          Best regards
          Sicom Test

          Reply
    • Good morning,
      Yes, displays are subject to CE marking, with all the obligations that derive from it, even if the product is customized.
      Best regards
      Sicom Test

      Reply
  2. Good morning
    A manufacturer from a non-EEC country provides me with a customized product with my brand.

    1) If I make it available on the market within the EU, am I therefore both a manufacturer and an importer?

    2) If I also make the product available on the non-EU market, what is my role, do I become a producer, importer and distributor at the same time?

    Reply
    • Good morning,
      1) By placing the product on the EU market with your own brand you are considered a Manufacturer and are subject to all obligations for Manufacturers.
      2) The role played in non-EU markets depends on the specific laws of the country in which the product is marketed.
      Best regards
      Sicom Test

      Reply
  3. Good morning
    I am setting up a company in Europe that will import class IIb medical devices. I am the manufacturer abroad and I already have the CE Iso certification etc... what do I have to do to start the business with the status of European manufacturer
    Thank you.

    Reply
    • Good morning,
      If the company in Europe will only import the devices it is subject only to the obligations for importers, the most important are:
      – Verify that the manufacturer has fulfilled the obligations for CE marking.
      – Ensure the integrity of the devices when in the possession of the importer
      – Keep a register of complaints
      – Withdraw products from the market if non-conformities are found.
      All obligations of importers of medical devices are indicated in article 13 of REGULATION (EU) 2017/745.
      As regards the manufacturing company, if it is based in a country that is not a member of the European single market, a sole representative (authorised representative) must be identified.
      The obligations and responsibilities of the agent and the method of designation are indicated in article 11 of REGULATION (EU) 2017/745.
      Best regards
      Sicom Test

      Reply
  4. good morning, I ask: do products imported (of any kind) from China into Italy have to have all the various indications in Italian? Thank you.

    Reply
    • Good morning,
      Yes, according to European directives the instructions accompanying a product must be in a language understandable to users in the country in which the product is marketed.
      Best regards
      Sicom Test

      Reply
  5. Good morning,
    A Chinese manufacturer has a designated authorized representative in the EU other than the importer; Who should appear on the product label? the importer or the authorized representative? A thousand thanks

    Reply
    • Good morning,
      Only the manufacturer and the importer must affix their references to the product (label).
      Best regards
      Sicom Test

      Reply
  6. Good morning. We are a shop that sells household items. We import from European Union countries, we want to apply our own labels as importers. What should this label contain?

    Reply
    • Good morning,
      According to European directives, the importer is a person established in the Union who places products from non-European countries on the market. If you import from EU countries, you are not an importer and you do not have to label the products as importers.
      Best regards
      Sicom Test

      Reply
  7. Good morning,
    In my case I purchased products from a toy supplier to sell them on an online marketplace, but they ask me, from the responsible person in the EU, for the CE marking conformity certificate for each of the brands I purchased. I'm not sure if the supplier can provide me with this information, I have to contact the manufacturer, what should I do, I'm a bit lost because there are several different brands even though I buy them from the same supplier. If you can help me with this question, I would greatly appreciate it. Thank you for your time.

    Reply
    • Good morning,
      The European Declaration of Conformity is drawn up and signed by the manufacturer before placing the product on the market; you can contact the manufacturer for a copy.
      Your supplier may also have a copy as, although there is no legal requirement, manufacturers often provide a copy to distributors.
      Best regards
      Sicom Test

      Reply
  8. If the manufacturer is located in the European Union and the goods come from a factory in China, can the importer's obligation to provide the name and address be waived? Of course, on the products, zb cardboard labels. and individual, the manufacturer is indicated.

    Reply
    • Good morning,
      The indication of the importer can be waived if this corresponds to the manufacturer, as anyone who puts products on the market with their own brand is considered a manufacturer.
      Best regards
      Sicom Test

      Reply
  9. Good morning,
    should the importer's address be applied before going through customs to the EU? or only at the time of placing on the market? Thank you

    Reply
    • Good morning,
      According to European directives, an importer must fulfill his obligations before placing the product on the market.
      Best regards
      Sicom test

      Reply
  10. 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 who distributes it in the UK in their stores under their brand.
    What must appear on the label?
    Produced by…(first production company)
    Imported by the second company (importer)
    Distributed by a third party (UK distributor)

    Reply
    • Good morning,
      According to both European directives and UK regulations: an importer or distributor is considered a manufacturer and is subject to the manufacturer's obligations when he places electrical equipment on the market under his own name or trademark or modifies electrical equipment already placed on the market.
      Therefore the company that distributes the product under its own brand will be considered as a manufacturer, it will be responsible for the products it sells and their conformity; only the name of the distributing company will appear on the label, which however must be indicated as the manufacturer.
      Best regards
      Sicom Test

      Reply
  11. Good morning,
    I have a doubt. When we talk about a distributor who puts his own brand, what do we mean? I'll give you an example: the distributor's logo is affixed to a PPE labeled by the manufacturer (and containing the relevant information) (but not on the label). Does the manufacturer remain the one who produced it or does he become the one who put the logo on the outside of the product?
    Thank you

    Reply
    • Good morning,
      According to the directives “An importer or distributor is considered to be a manufacturer for the purposes of this Regulation and is subject to the manufacturer's obligations referred to in Article 8 when he places PPE on the market under his own name or commercial trademark or modifies PPE already placed on the market in such a way that compliance with this regulation may be compromised.”
      The logo is a commercial trademark, so if the distributor places its logo on the product it may be subject to the manufacturer's obligations.
      Best regards
      Sicom Test

      Reply
    • Good morning,
      For any product, the manual must contain instructions for correct use, 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 it.
      Best regards
      Sicom Test

      Reply
  12. HI
    If I brand (logo) my product which has already obtained the CE mark in Italy
    Am I the manufacturer or the importer?

    Thank you
    Angela

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

      Reply
  13. Hello good morning we have
    Having patented a vending machine, I wanted to understand if we have a company that carries out trade and not production. we could put the marking on our machines even though we are not the producers

    Reply
    • Good morning,
      A manufacturer is considered to be "the natural or legal person who manufactures electrical material, or who has it designed or manufactured, and markets such material under his own name or trademark".
      The manufacturer is responsible for the CE marking
      Best regards
      Sicom Test

      Reply
  14. Good morning, purchase with regular invoice, as a wholesale distributor, within the European community, in Italy and abroad, spare parts for telephones, in this case displays and batteries. In addition to the writing on the made in China packaging, there is no reference to the importer or to the European distributor. but on accessories yes. How should I behave? do we need to integrate with a label? or is that okay? I know that around the competent authorities (gdf), ask for the presence of the province on the convection.

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

      Reply
  15. Good afternoon,
    must it be indicated “imported from….with company name etc…or is just the company name sufficient? Thank you

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

      Reply
  16. Hi good morning,
    I have to import some electronic devices from China that have the manufacturer's CE certifications, but are supplied to me by a distributor of this manufacturer. Do I have to include 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.

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

      Reply

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