fbpx
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 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, 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 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.

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.

Related Articles

smart-home-domotica home automation-security EU-labeling

82 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

        • Good morning
          I import a product from Germany. And I created a new label to translate into French with a new trade name. I have to put the manufacturer's name on this label or just state that I am a distributor?

          Sincerely

          • Good morning.
            In the event that the product is placed on the market under a trade name other than that of the manufacturer, the distributor assumes the obligations of the manufacturer and therefore the name of the distributor must appear on the label.
            Greetings from Sicom Testing

        • We are distributors, we sell medical products to dental offices but also to companies that are also distributors, these companies ask us to send us a declaration of conformity, CE certificates, Instructions for Use, etc. to the medical devices they buy from us. As a distributor, we are obliged to provide them with these documents? If so, where this requirement is specified?

          • Good morning,
            The obligations of distributors are indicated in the article 14 of the medical directive, as a distributor you have a duty to provide instructions, which must be drawn up by the manufacturer according to Annex I, point 23 Directive, in one of the official languages ​​of the Union established by the Member State in which the device is made available to the user or patient. If they are absent you must not distribute the product.
            The declaration of conformity and the documentation necessary to demonstrate the conformity of a device must be kept available to the competent authorities.
            Greetings Sicom Test

  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

    • I imported the product as an authorized representative. Unfortunately it has a bad Chinese-CE mark on it and the product is from Pakistan. As an authorized representative, can I put a CE mark in accordance with the EU product directive? All documents such as CE and declarations are correct

      • Good morning.
        According to the directives, per “authorized representative” means the person appointed by the manufacturer by means of a written mandate. The authorized representative does not have the same obligations as the manufacturer or importer, but performs the tasks specified in the manufacturer's written mandate. In case of non-conformities found on the product, the authorized representative can notify the manufacturer and the supervisory authorities.
        The importer, instead, who believes or has reason to believe that the electrical material he has placed on the market is non-compliant, immediately takes the corrective measures necessary to bring such electrical material into compliance.
        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

  13. Regards.
    I have a question on the definition of the importer and distributor.
    For example, we have a manufacturing company (the art. Company A) located not in the EU. This company has a customer (company B) which is based in the EU. Company B will purchase items, produced by company A and then will sell them on the EU market. Then, we will consider company B as an importer under the MDR?

  14. Saluti,
    Ho una domanda riguardante l’obbligo dell’importatore ai sensi dell’articolo 8, paragrafo 6, della direttiva 2014/35 / UE.
    La mia domanda è: come si applica nel tempo l’obbligo dell’importatore ai sensi della direttiva citata (di valutare il rischio, testare e indagare)? Qual è il contenuto di questo obbligo? Ha solo lo scopo di garantire la conformità del prodotto alle norme armonizzate dell’UE?

    L’apparecchiatura elettrica è stata prodotta secondo la legislazione UE e ha DoC. Va tutto bene, fino a quando l’attrezzatura non è stata danneggiata durante l’evento assicurato. Secondo la valutazione del produttore e dell’importatore, il dispositivo è ora un rischio per la salute, poiché è stato compromesso dall’acqua. il danno non può essere misurato per così dire. Il rischio potenziale viene assunto dall’estensione dell’esposizione all’acqua, inoltre si tratta di un dispositivo appositamente calibrato, quindi qualsiasi esposizione potrebbe potenzialmente rovinare il lavoro che si suppone debba fare.
    Tuttavia, secondo la compagnia di assicurazioni, “sembra funzionare normalmente”. La compagnia di assicurazioni ora fa pressioni sull’importatore affinché fornisca misurazioni oggettive del rischio, non solo valutazioni, il tutto per far valere i suoi obblighi ai sensi di detta direttiva.
    A seguito di ciò, questo evento rende tale dispositivo non conforme? È un fattore di rischio che potrebbe causare danni alla conformità del prodotto?

    Grazie per il tuo tempo

    Mark

    • Good morning.
      The importer is required to ensure product compliance on the market for as long as the product is on the market.
      If the importer believes or has reason to believe that the product does not comply with the requirements of the applicable directives, he does not place the electrical material on the market until it has been made compliant. Moreover, when the product presents a risk, the importer informs the manufacturer and the market surveillance authorities.
      In the specific case, if the manufacturer and the importer believe that the damaged product represents a risk, immediately take the corrective measures necessary to bring such electrical material into conformity, to withdraw or recall it, as appropriate.
      The risk assessment and any damage to product conformity is the responsibility of the manufacturer, because he is the person who knows his product best and knows how to technically evaluate its risks.
      Greetings from Sicom Testing

  15. Good morning,

    If the same article, made in China, it is imported and distributed by several different legal entities on the European territory, it is possible and allowed to affix the name of the various importers on the product / pack, in order to have a single pack for all European countries?

    Example:
    IMPORTED BY ROSSI ITALY SPA
    IMPORTED BY ROSSI FRANCE SA
    IMPORTED BY ROSSI GERMNAY AG

    Thanks for your feedback

    • Good morning.
      The important thing is that each importer has evidence of product conformity collected in his own technical manufacturing dossier (schemes, components list, test reports and anything else required).
      Greetings from Sicom Testing

  16. Good morning,
    I wanted to clarify the import of a product subject to EC Certificate of Conformity from a non-EEC country.

    In the specific case, we are distributors of a US supplier that has not CE marked servers.
    Customs inspection, noted this absence, blocking the release of the material.

    I seem to have read that in these cases, the importer is responsible for providing this certification, but if the goods are not released, how is it possible to take them to the accredited laboratory for testing and issuing the certification ?

    Finally, if this product is then sold to a person residing in a non-EEC country or to a customer who will then integrate and resell it in turn, CE marking is always required?

    • Good morning.
      We understand that there are practices for the customs clearance of samples aimed at their testing and that there are practices for the transit of a product through a customs area that is not the final destination. This information should be requested from the Customs Agency. You may need to hire a “customs officer” or an import-export company to carry out the paperwork.
      Greetings from Sicom Testing

  17. Dear,
    we have long hesitated with the terms of the definition, distributor-buyer of goods-importer-supplier to the market …
    1) Ok, it is clear to us that if we buy goods from non-EU countries then we are an Importer?
    2) If we buy goods from EU member states, then we are the buyer of goods?
    3) But what if we buy goods from a representative of a commercial traveler from Croatia and the company he represents comes from an EU country and our invoice comes from that EU country, then we are the buyer of goods? And if that passenger represents a company that is not a member of the EU and the invoice comes to us from the same company, then we are the importer?
    4) What happens if we buy the same goods from a company in Croatia, and that company is the buyer of goods, we receive an invoice from a company from Croatia, what are we in that case? Distributors? And what are we if that company is an importer? Still a distributor?
    Thankful in advance.
    With respect

    • Good morning.
      1) Yup, the importer is the natural or legal person established in the European Union who places products from third countries on the Union market.
      2) If the products you buy within the Union then make them available on the market, then in this case you are distributors.
      3) If the company you buy from is within the European Union, then you become distributors. If the company is located outside the Union, then you become an importer.
      4) If you make the products available on the market, in both cases you are distributors.
      Greetings from Sicom Testing

  18. Good morning,

    In case the manufacturer is a Japanese company (overall), based in the EU (subsidiary company), the latter has the category of importer or only authorized representative?
    The figure of the importer would be mandatory or it is sufficient for the EU subsidiary to fulfill the requirements of the authorized representative?

    Many thanks in advance,
    Regards

    • Good morning.
      The authorized representative is a person who is appointed by the manufacturer by means of a written mandate. In this case, the branch based in Europe is configured as an importer if it places the product on the market.
      The authorized representative fulfills the tasks specified by the manufacturer in his mandate, while the importer is the person who places the product on the market. These are two different figures with defined tasks and responsibilities.
      Greetings from Sicom Testing

  19. Salve, a question: if the manufacturer is outside the EU and has to put on the EU market, it will mark the machine CE and also issue the EU Declaration of Conformity; in this last document the data of the importer must be indicated? In which technical documentation must the data of the importer be indicated?
    Thanks for the clarification!

    • Good morning.
      The EU declaration of conformity must be drawn up by the importer of the product from a third country.
      In general, the importer indicates his name on the product, your registered trade name or registered trademark and the postal address at which you can be contacted or, where this is not possible, on the packaging or in a document accompanying the product.
      Greetings from Sicom Testing

      • Good morning, Thanks for the reply. But in your case you are considering that the product is not already CE marked and therefore everything would fall on the importer . But if the product is already CE marked (and the manufacturer is not in the EU) where the importer must be indicated?
        Thanks again

        • Good morning
          Importers indicate their name on the material, their registered trade name or registered trademark and the postal address at which they can be contacted or, where this is not possible on the packaging or in a document accompanying the material. The contact information is in a language that is easily understood by the end user and the market surveillance authorities.
          This is information in addition to the manufacturer's data.
          It remains the duty of the importer, for ten years from the date the material was placed on the market, keep the EU declaration of conformity available to market surveillance authorities, also ensure that, on request, Technical documentation will be made available to those authorities, and following a reasoned request from a competent national authority, provide the latter with all information and documentation, in paper or electronic format, necessary to demonstrate the conformity of the material (manufacturing technical dossier), in a language that can be easily understood by that authority.
          It remains the importer's duty to ensure that the goods actually comply with European legislation.
          Regards
          Sicomtest

  20. Good morning
    We import a product from the United States and the manufacturer has issued the CE declaration of conformity for the product.
    As importers we have other obligations?
    garzie

    • Good morning
      Indicate your name on the material, your registered trade name or registered trademark and the postal address at which you can be contacted or, where this is not possible on the packaging or in a document accompanying the material. The contact information must be in a language that is easily understood by the end user and the market surveillance authorities.
      Keep at the disposal of the competent authority, for ten years from the date the material was placed on the market, the EU declaration of conformity, technical documentation and documentation, in printed form
      or electronic, necessary to demonstrate the conformity of the material (manufacturing technical dossier). Make sure that the goods actually comply with European legislation.
      Regards
      Sicom Test

  21. good morning, I am a manufacturer of mechanical equipment and I want to contact a distributor for sales all over the world: the competence of the language translation of the manuals is mine as a manufacturer or to the exporter / distributor? I must refer to those laws?
    Thank you in advance

    • As regards the European Union, the directives give this responsibility to the manufacturer; before making the material available on the market, distributors must verify that it bears the CE marking,
      it is accompanied by the required documentation as well as instructions and safety information in a language easily understood by consumers and other end-users in the Member State where the material
      must be made available on the market.

      • Good morning,
        I have purchased CE certified lifting equipment, I am unable to receive a duplicate certificate of conformity.
        I have to ask the Belgian seller to issue me another certificate or other document. If, what kind of document, procedure?
        thanks

        • Good morning,
          Lifting equipment falls under the machinery directive, according to this directive, the machine must be accompanied by its European declaration of conformity; then the vendor of the machine must provide it to you.
          Kind regards
          Sicom Test

  22. Good morning,

    In case you are only distributing equipment from a Chinese OEM, there is a way to free myself from the costs of certification (CE standard)? If I don't change the name of the original supplier, I just add a contact label with my company, for example, the manufacturer remains the Chinese OEM? And it is therefore he who must guarantee the CE certification?

    • Good morning,
      In the event that equipment from a manufacturer from a non-EU country is placed on the European market, there must be an importer who is responsible for ensuring that the manufacturer has performed the appropriate conformity assessment procedure, that the manufacturer has prepared the technical documentation, that the CE marking is affixed to the product, that the latter is accompanied by the required documents. In addition, the importer must keep all documentation available to the market surveillance authorities for 10 years from the date the product was placed on the market.
      Before making the product available on the market, distributors must verify that it bears the CE marking, it is accompanied by the required documentation as well as instructions and safety information in a language easily understood by consumers and other end users in the Member State where the product is to be made available on the market and that the manufacturer and importer have complied with the legal requirements.
      Therefore, it is the manufacturer who must ensure compliance with CE standards, importer and distributor have the duty to verify that the manufacturer has fulfilled his obligations, and if the manufacturer has not done so, they must not place the product on the market.
      Kind regards
      Sicom Test

  23. Good morning,
    we are agents of a Chinese company that manufactures glass processing machinery. These machines come with a declaration of conformity issued by the manufacturer, but it lacks the name of the agent and for this reason it is not accepted for the practices of the Industry 4.0
    What are the responsibilities of the authorized representative and what he must receive from the manufacturer? Thank you

    • Good morning,
      According to the machinery directive, these physical and / or legal persons must be identified in the declaration of conformity:
      1. Company name and full address of the manufacturer e, I know about the case, of his authorized representative;
      If the manufacturer is from outside Europe, the authorized representative must also be indicated in the declaration of conformity(by definition, the agent is a natural or legal person established within the EU).

      2. Name and address of the person authorized to compile the technical file, which must be established in the Community;
      In addition to the declaration of conformity, there must be a person responsible for the technical file that must be established in the EU and provide all the documentation to the authorities if this is requested.

      The declaration of conformity must have this information and all that indicated in Annex II of the directive.
      The full definition of agent is: any natural or legal person established within the Community who has received a written mandate from the manufacturer to perform on his behalf, in whole or in part, the obligations and formalities associated with this Directive.
      In order to be placed on the market, the machinery must meet all the requirements of the directive, which of these obligations and formalities must be carried out by the manufacturer or the authorized representative is indicated in “written mandate”.
      Cordiali Sounds

  24. Good morning

    I am in talks with a Chinese manufacturer to sell their product on the European market. we have decided to sell this product under our own brand.
    In this case I am a producer or an importer?
    There is a way to sign a contract with the manufacturer specifying that the manufacturer remains financially responsible for any future problems that the importer may encounter in the future and that he must necessarily provide technical assistance to solve the problem?
    where can we find this type of contract?
    Sincerely

    • Good morning,
      According to the Radio directives (2014/53/I – article 14) and Low voltage (2014/35/I – article 10) when an importer places a product under his brand on the market he is subject to all the obligations of the producer.
      The directives indicate the legal obligations of manufacturers and importers but say nothing about agreements between the parties.
      Greetings Sicom Test

  25. Good morning, I am a distributor of PPE as my products are imported from European companies where I supply myself.
    I wanted to know if as a distributor I am obliged to insert the words in Italian on every single product or only on the packaging.
    Could you give me some regulatory references?
    Thank you.
    Simone

    • Good morning,
      The obligations of distributors are defined in the article 11 of the REGULATION (EU) 2016/425, the paragraph 2 obliges the distributor to verify that with the product there are all the information and markings required by law and that these are in a language that is easily understood by consumers and other end users of the Member State in which the PPE is made available on the market.
      The information requested is indicated in point 1.4 of Annex II of the regulation.
      Greetings Sicom Test.

    • Good morning
      An importer or distributor is considered a manufacturer and is subject to the manufacturer's obligations when he places a product on the market under his own name or trademark or modifies products already placed on the market in such a way that compliance may be compromised..
      Greetings Sicom Test

  26. Dobbiamo nominare un importatore per l’intera UE o ciascuno dei nostri distributori deve registrarsi come importatore?

    • Good morning,
      According to European directives:
      – an importer is any natural or legal person established in the Union who places products originating in a third country on the Union market;
      – a distributor is any natural or legal person included in the supply chain, different from the manufacturer or importer, that makes the products available on the market;
      if your distributors place products originating in a third country directly on the Union market, they are considered to be importers.
      Greetings Sicom Testing

  27. Ciao
    Siamo il “produttore” per il prodotto X importato dal nostro OEM all’estero.
    Prodotti X (indirizzo del marchio X e X stampato sul prodotto)

    Uno dei nostri distributori “A” decide di rinominare il Prodotto X in Prodotto A rietichettando la confezione con l’indirizzo del marchio A(ma all’interno della confezione il prodotto A ha ancora l’indirizzo del marchio X e la scheda tecnica del marchio X).
    Per quanto ne so, il Distributore A diventerà il Produttore.
    1. Può creare confusione per i consumatori il fatto di avere due marchi e indirizzi diversi sullo stesso Prodotto?
    2. È questo il modo giusto per rietichettare la confezione (rebranding in Brand A) senza modificare l’indirizzo del marchio X (già stampato sul prodotto)?
    3. Il prodotto fisico necessita di un rebranding?

    Grazie
    Jack

    • Good morning,
      1. When it does a rebranding “A” is subject to all obligations of the manufacturer, among these there is the obligation to indicate the manufacturer, and if necessary his address; the article 6, section 7 of directive 2014/35 / EU (LVD) states that instructions and labeling must be clear, understandable and intelligible. The technical standards require that the labeling be done in such a way that there can be no confusion.
      2. In general, the manufacturer is the one indicated on the product, the article 6, section 6 of directive 2014/35 / EU (LVD) he claims “Manufacturers indicate their name on electrical equipment, their registered trade name or registered trademark and the postal address at which they can be contacted or, where this is not possible, on the packaging or in a document accompanying the electrical equipment”. The information on the packaging should not be different from that on the product.
      3. The physical product needs rebranding if A is to be listed as a manufacturer.
      Greetings Sicom Test

  28. Buongiorno,
    Vengo da un paese extra UE e sto cercando di vendere prodotti nell’UE. Ho stabilito un soggetto di diritto europeo nella UE. Ho un produttore OEM che è stato autorizzato a stampare un marchio sul prodotto OEM supportato dal mio accordo con il marchio stabilito. Il produttore OEM mi ha detto che dovrebbero fare tutte le certificazioni all’interno dell’UE inserendo il nome del produttore sulle etichette e sulle applicazioni, credo che dovrei richiedere le certificazioni sotto la responsabilità del mio soggetto di diritto europeo e diventare così il produttore “legale”. Oltre ai diritti di branding, ci sono altri motivi legali per costringere il mio OEM a consentirmi di farlo.

    • Good morning,
      The responsibility for carrying out all tests for the CE marking rests with the manufacturer (the one who puts his own brand on the product), while the responsibilities of the importer and distributor include verifying the correctness of the documentation for the CE marking.
      Kind regards
      Sicom Test

  29. Good morning,
    How it should behave, a company that imports and distributes machines exclusively in Portugal, in relation to customer and third party requests, for the declaration of conformity for machines sold by more than 10 years? In other words, the customer declares not to have the declaration of conformity, the importer is obliged to make it available? And if I don't have it?
    Thanks in advance.

    • Good morning,
      According to the directives “For ten years from the date the electrical equipment has been placed on the market, importers keep the EU declaration of conformity”, nothing is said about the obligations of importers after this period.
      Kind regards
      Sicom Test

  30. If as a manufacturer I am also an importer, I have to indicate my contact details twice on the nameplate (once as a manufacturer and once as an importer)? In this case it is mandatory to enter "Manufacturer" and "Importer"?
    Thanks in advance

    • Good morning
      The importer is the natural or legal person established in the Union who places electrical material originating in a third country on the Union market; If you are established in the European Union according to the directive, you are only manufacturers and not importers; if you are from a third country you must indicate your data as “Manufacturer” and the data of your branch in the union such as “Importer”.
      Kind regards
      Sicom Test

  31. Good morning, wanting to import a new product covered by a patent and therefore not covered by a reference legislation (technical or legislative EU) CE compliance as it applies? By similarity to other elements that are closest in application-function?

    • Good morning,
      The directives that apply depend on the characteristics of the product itself, the fact that it is patented has no influence on the applicable directives.
      Kind regards
      Sicom Test

  32. Good morning,

    We are resellers and manufacturers of medical devices and more resellers of indoor sanitizers.
    Our company is CE marked, ISO 9001 and 13485 by an Italian Notified Body. We import a sanitizer that is not a medical device from South Korea. This product has the CE conformity issued only by the non-European manufacturer, then, to be able to resell it in Italy, this conformity must also be drawn up by the European representative, it's correct? Should we take on the burden of becoming European representatives, what it would entail? We must contact our Notified Body?

    Thanks in advance

    • Good morning,
      The obligations of a representative of an authorized representative are:
      a) keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for ten years from the date the product has been placed on the market;
      b) following a reasoned request from a competent national authority, provide this authority with all the information and documentation necessary to demonstrate the conformity of the Product;
      c) cooperate with the competent national authorities, at their request, any action taken to eliminate the risks presented by the product which falls within the mandate of the authorized representative.
      d) other administrative obligations if specified in the mandate, among which there may be:
      - affix the CE marking on the product (and where appropriate other markings) and the number of the notified body (if requested);
      - draw up and sign the EU declaration of conformity.

      The manufacturer non it can delegate the necessary measures to ensure that the manufacturing process ensures the conformity of the products and the preparation of the technical documentation.

      Furthermore, if the authorized representative appointed by a manufacturer is also an importer or a distributor under the Union harmonization legislation, is also required to fulfill the obligations of the importer or distributor.

      Kind regards
      Sicom Test

  33. Good morning,
    Our company commissions the production of products in China and has the brand affixed to them on site (the product leaves the Chinese factory branded with our logo).
    The import is entrusted to an Italian company.
    Our company, which markets the product in Italy, it is only distributor (and therefore the obligations fall on the importer) O, having affixed its own brand, he is also a Producer? Thanks so much

    • Good morning,
      according to the directives “An importer or distributor is considered a manufacturer for the purposes of the directives and is subject to the obligations of the manufacturer when he places electrical equipment on the market under his own name or trademark or […]”; therefore your company is considered a manufacturer.
      Kind regards
      Sicom Test

Questions and comments

If you have questions or comments
Sicom Testing will be happy to answer them.