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.

Marking-ce-appliances

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 info@sicomtesting.com
or call +39 0481 778931.

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28 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
    Giuseppe

    • 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

        • Good morning,
          can consult the European directives for placing products on the market, among these for example:
          – Directive 2014/35 / EU(LVD) “concerning the harmonization of the laws of the Member States relating to the making available on the market of electrical equipment intended to be used within certain voltage limits”
          – Directive 2014/30 / EU (EMC) “on the harmonisation of the laws of the Member States relating to electromagnetic compatibility ”
          – Directive 2014/53 / EU (RED) “concerning the harmonization of the laws of the Member States relating to the making available on the market of radio equipment”
          However, the rules are similar for other directives as well.
          Greetings from Sicom Testing

  3. A manufacturer not established in the EU is obliged to appoint an authorized representative? The mere fact that the importer is in the market will cause him to be responsible and act as a representative?

    • Good morning,
      importer and authorized representative are two different figures.

      The authorized representative carries out his function by the will of the manufacturing company located outside the EU.

      The importer acts of his own will, buys a product outside the EU and imports it, is responsible for placing the product on the European market and has a commercial relationship with the manufacturer. It must therefore guarantee the CE certification of the product in cases where it is applicable and that all connected pieces in circulation are compliant, for example through spot checks on batches. He does not become a representative of the non-European company.

      Greetings from Sicom Testing

  4. Buongiorno,
    Ci sono altri obblighi che il distributore dovrebbe rispettare?
    Forniremo i nostri prodotti ai distributori del Regno Unito che distribuiranno i nostri prodotti in 10 paesi dell’UE. (Germania, Francia, ecc.) Ma non possiamo essere sicuri che abbiano la responsabilità di farlo. Esistono leggi nazionali sugli obblighi dei distributori in ogni paese dell’UE?

    • Good morning,
      the distributor is required to verify that the product bears the CE marking, is accompanied by the necessary documentation as well as instructions and information for the consumer, before placing it on the market. If the distributor believes the product is non-compliant or represents a risk, is required to inform the manufacturer or importer.
      The distributor is also obliged to ensure that, while the product is under his responsibility, there are no risks that could compromise the conformity of the product.
      At national level there are laws relating to the obligations of the distributor but these are often transpositions of European directives.
      Greetings from Sicom Testing

  5. Good morning,

    I work for a company that distributes medical devices to hospitals. Until now I had understood that an importer is the first company to buy a certain product (made outside the EU), to then distribute it in the EU.
    So I thought: for every product there is 1 importer and other companies that distribute the same product are distributors.

    Now I hear from a colleague of another company that every company that distributes products (made outside the EU), in Europe, is automatically an importer. This means that for 1 single product produced outside the EU, there may be multiple importers.

    What is correct?

    Thanks in advance for your reply,

    Nathalie Massa.

    • Good morning,

      if you buy the product from a European company that imported it then you are distributing it.

      If you buy the product outside the European community, you are an importer even if someone else has previously imported the same product (but not the same pieces).

      “The first company to buy a product” it is to be understood in the sense of the supply chain and not in a chronological sense.

      In other words, each piece that reaches the European market must go through a person responsible for placing it on the market.

      Greetings from Sicom Testing

  6. Good morning, I purchase a product from India (without CE certification). The moment I get it CE certified and issue the “Incorporation statement”, my figure remains that of the Distributor (I market) or my role indirectly assumes that of the Manufacturer (producer)? Basically I would like to understand if the role of the importer changes, which markets directly, when I certify a CE product and especially if I assume the role of MANUFACTURER. The product is produced in India or Italy as it is CE certified by me? Thank you

    • Good morning.

      The importer who places the product on the European market is solely responsible for that product for all formal aspects and responsibilities towards third parties. He does not become the producer, but has the same responsibilities as a manufacturer based in the European community.

      The distributor buys and sells in the European community and is co-responsible for all verifiable aspects without technical investigations, then labels, markings, manuals, documentation, congruous presentation, etc.

      Greetings from Sicom Testing

  7. Good morning,
    we are preparing to put on the European market a product intended for sports practice, does not consist of electrical products or other components subject to specific legislation. Despite much research, I do not see what forces me to affix (and therefore justify) CE marking (no machine directives, etc …).
    You have an opinion on the situation?
    Regards

    • Good morning.
      This type of product falls under the GSPD 2001/95 / EC directive relating to general product safety and in particular the EN standard applies 957-1 specific for sports equipment.
      Greetings from Sicom Testing

  8. Good morning.
    I have a question a little’ similar to the previous one.
    We are establishing a sporting goods retail company ( no containing electrical appliances, neither clothing, in contact with food)
    Production will take place EXTRA EU on our recommendation, on our indications, as well as the packaging. The product will arrive in Italy ready for sale.

    From what I understand from the regulation 765/2008 we will be manufacturers.
    What obligations do we have as manufacturers?

    • Good morning.
      There is a harmonized standard for this type of product under the General Product Safety Directive GPSD 2001/95 / EC. The standard is EN 957-1.

      The manufacturer's obligations can be summarized as follows:

      – Identify the directives applicable to the product (these directives indicate requirements that must be respected).
      – Identify the harmonized standards applicable to the product and suitable for demonstrating compliance with the requirements of the directives.
      – Fully apply the harmonized standards by carrying out all the tests, verifications, rating, calculations etc. required. (this can be done internally or by using a trusted laboratory).
      – Collect in a dossier (manufacturing technical dossier) the product documentation and the results of all the tests carried out. This dossier should be made available to market inspectors for 10 years.
      – Ensure that all the parts produced comply with the one tested initially and therefore comply with the requirements of the applicable European directives.
      – Take into account the updates that occur to harmonized standards and other technical standards applied to the product.

      The GPSD directive does not provide for the affixing of the CE mark, nor the presence of the European declaration of conformity of the product.

      If the product falls under the machinery directive, the procedure is more complex.

      There may be other obligations regarding consumer rights, product assistance, waste disposal, etc.

      Greetings from Sicom Testing

  9. Good morning, once I have requested the CE certification from the manufacturer, how can I do to ensure that the product is really suitable for marketing in the EU ? Moreover, if the product seen by the distributor but certified by the non-EU manufacturer is not compliant, the responsibility lies with the manufacturer or distributor?
    Thank you.

    • Good morning,
      as a customer or as a merchant, the fact that the declaration of conformity is present is sufficient.

      The supporting documents are found in the manufacturing technical dossier which can be requested by the market control authorities.

      If the nature of the relationship with the manufacturer (or otherwise responsible for placing the product on the market) generates the need to deepen these aspects, the only way is to request the manufacturing technical dossier, which can be given or denied. It's’ a matter of relations between private parties.

      If the marketed product is not compliant, the responsibility falls on the economic operator concerned, identified according to individual cases.

      Greetings from Sicom Testing

  10. Good morning, by importing a UL certified relay from China but without EU declaration or CE mark and having to insert it in a device assembled in Italy but which will be distributed only in the USA, it is necessary to provide for the European certification?
    Kind regards

    • Good morning.
      In this case, the CE marking is not required, the product must be certified for the market it is intended for.
      Greetings from Sicom Testing

  11. Good morning. A manufacturer supplies me with a customized product with my brand. I am a distributor of this product. I have all the technical documentation (certification, test report) of the manufacturer. In this case I fall into the role of manufacturer or distributor? I can customize the technical documentation by affixing my logo ?
    Thank you

    • Good morning.
      In the event that the distributor markets a product by affixing its name or trademark, the subject in question is considered by the legislation to be the same as a manufacturer and must meet all the obligations associated with his role. The technical documentation must therefore be made out to the person in question.
      Greetings from Sicom Testing

  12. Ciao.
    I purchased the goods from the importer, it is not marked, there is no device type and model
    The buyer filed a complaint and returned the goods due to the impossibility of identifying himself with the technical documentation.
    The importer may refuse to take back the goods?
    I am just a broker.

    • Good morning,
      Anyone who sells goods that do not bear the necessary markings is out of order, be it an importer, distributor or retailer. The product must be regularized or withdrawn from the market. The division of costs and damages between these parties must be discussed by the lawyers of the parties.
      Greetings from Sicom Testing

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