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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Good morning,
We are a company operating in a non-EU country without means of production, only design skills. We want to sell a product that we have produced in China in EU countries under our brand.
For this product, Chinese manufacturer has CE in accordance with directives such as EMC, LVD, PED. But when we want to sell it to EU countries under our brand, we assume the role of producer? In this case, we must prepare on our behalf the technical dossiers prepared for all the manufacturer's directives and obtain approval from an accredited institution and have the CE certificate approved?
Good morning,
Yes, in this case, according to European directives, you are considered a manufacturer and therefore you must prepare the technical file of the product and draw up the European declaration of conformity.
The EU-type examination certificate, issued by a notified body, it is only necessary in some cases, indicated by the Directive: it is not mandatory for the EMC and LVD directives while for the PED it depends on the characteristics of the product.
Kind regards
Sicom Test
Good morning,
a potential distributor must fulfill other obligations in addition to those listed above, such as requesting authorizations or subscribing to some type of register to report the sale of dm? I specify that in this case it is dm, class 1.
Thank you.
Good morning,
the directive and regulation on medical devices do not require distributors to apply for authorizations or register in any type of registry.
For medical devices it is specified that in ascertaining the compliance of the products with the directives of the European Community, the distributor must verify that:
a) sia stata apposta la marcatura CE al dispositivo ed sia stata redatta la dichiarazione di conformità UE di quest’ultimo;
b) the device is accompanied by the information to be provided by the manufacturer 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 and that the information on the label is indelible and written in such a way as to be easily legible and clearly understood by the intended user or patient.
c) for imported devices, l’importatore abbia indicato sul dispositivo o sul suo confezionamento o in un documento che accompagna il dispositivo il suo nome, its trade name or registered trademark, its registered office and the address at which it can be contacted so that it can be located.
d) il fabbricante, I know about the case, has assigned a UDI to the device.
It is also specified that the distributor must keep a register of complaints, non-compliant devices as well as recalls and withdrawals, and keep the manufacturer informed of this monitoring e, I know about the case, the authorized representative and the importer and provide them with all the information they request.
hello
I would like to import aesthetic technologists from China.
I have found a supplier who has already provided me with the CE, which I checked on the website of the European certification body and is real, and I want to buy.
I purchase them for resale.
What responsibilities do I face if I put my label on technology, but writing distributed by company XXXX?
thanks
Good morning,
In your case, the obligations of the importer and distributor apply, which are for all directives:
1) Check that the technical documentation and the European declaration of conformity have been drawn up and that there is the CE mark on the product.
2) Verify that the product is supplied with proper instructions.
3)Withdraw the product from the market if you become aware of the fact that the product has non-conformities.
4)Keep a copy of the declaration of conformity for 10 years after the sale of the last product.
5)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 product, in a language that can be easily understood by that authority.
There may be other obligations depending on the specific directives applied to the product, if the directive on medical products has been applied, refer to the regulation 2017/745 articles 13 and 14.
Kind regards
Sicom Test
Good morning,
what documentation you have to produce if you want to resell (as an importer / distributor) of CE marked products without displaying the manufacturer's name?
It is possible to issue an EC declaration signed by the importer / distributor?
Thank you.
Good morning,
When an importer / distributor resells the product as his own, ie with its brand, according to European directives it is considered to all intents and purposes a manufacturer and therefore has all the obligations of the manufacturer including issuing a European declaration of conformity, produce the Technical Manufacturing Dossier, ensure the conformity of all production.
Kind regards
Sicom Test
Have a good evening!
I am a distributor of an equipment brand, with a manufacturer in Japan and a representative in Europe of the same brand. However, is another company that distributes in Portugal and Spain. According to current legislation, who has to translate the EC declaration of conformity into Portuguese and Spanish? What data should it contain, ie it should contain only the data of the manufacturer and representative in Europe or even of the distributor? Who should sign it?
Thank you.
Good morning,
The declaration of conformity must be completed and signed by the manufacturer or his authorized representative and must be in a language that is easily understood in the country where the product is placed on the market.
The distributor does not have to be indicated in the declaration of conformity; the distributor is responsible for verifying that the documentation is complete.
Sincerely
Sicom test
I have submitted the application, where can I get the CE certificate and Declaration of Conformity for MP that we bought from a manufacturer in Switzerland? It is in demand from our long-term customer.
lp
Lilijana Jurman
Good morning,
the EU Declaration of Conformity and the technical documentation relating to the product certification are the responsibility of the manufacturer, to which you can request the sending of the aforementioned documentation.
Sincerely
Sicom Testing
Good morning, I would like to know if more companies can take the Ce in the same country, since there is no exclusive sale, or whether the second company must necessarily switch from the first. Thank you
Good morning
The CE marking is applied to products not to companies, when a company places a product on the market, if the CE mark is required for the latter, the company must verify its compliance with European directives; after compliance has been demonstrated, the company issues the declaration of conformity, affixes the CE mark to the product and can place it on the market. The person in charge of the CE marking is the manufacturer, importing and distributing companies, before selling the product, they only need to verify that the documentation for the CE marking is complete and that the declaration of conformity has been filled in and signed by the manufacturer (or by its representative based in the European Union if the company is non-European). If an importing or distributing company resells the product with its own brand, it is considered a manufacturer.
Regards!
We sell from 10 years a medical device to facilitate breathing (clip nasale in silicone) even to some pharmacies. We bought them from a Swiss manufacturer, have the CE mark. They made a Slovenian translation on the packaging before sending the medical device to us in Slovenia. We are a registered distributor for medical devices in Slovenia. Now, this same customer, who buys this device from us and puts it up for sale, asks us to send him the CE certificate and the Declaration of Conformity. Where can I get these documents? I have to request them from the manufacturer (agency) in Switzerland? Greetings Liliana
Good morning,
the European declaration of conformity and the technical documentation of the product can be requested from the manufacturer.
Kind regards
Sicom Testing
Two importers in Poland buy goods in Russia and transport them to the EU, there may be 2 importers on the label? Thank you for your reply.
Good morning,
According to our interpretation they cannot be indicated 2 importers on the label as the importer is responsible for the goods he imports; the data of the importer is information aimed at the consumer and for each product this reference must be unique; therefore each of the two importers must indicate his name on the device, his registered trade name or registered trademark and the postal address at which he can be contacted, on the commodity that actually imports.
Kind regards
Sicom Test
Ciao.
I have a hard time understanding the following: we are a company based in the United States that produces our products in China, in the EU we do not have a company but we have a tax representative, we import all our goods and then sell on the EU market. It is therefore correct to enter the name of our US company as an importer of goods in the EU?
Thanks so much,
Quince
Good morning,
The regulations state that the importer must reside within the European Union, therefore, a non-EU company is not expected to be an importer in the European market.
Greetings from Sicom Testing
Hi! I’m a bit confused when it comes to the definition of importer or/and manufacturer. We are going to import a medical device class IIa from China to the European marked. The product is CE-marked and have all the certificates requierd, Declaration of Conformity, iso 13485, saftey sheets, technical files and EC REP.
The product will be sold as our own brand with our design. Our main customer will be the pharmacies.
I spoke to The Norwegian Medicines Agency and they told me that my role would be importer as long as I don’t make any changes when the product has entered Europe. (Meaning that the manufacturer has approved the brand/label etc and shipped it to Europe)
So, how would you define my role? Importer or/and manufacturer
Kind regards Ellen
Good morning,
In our opinion, your role is exactly that indicated by the Norwegian Medicines Agency.
Greetings from Sicom Testing
Good morning,
It's’ CE certificate required if imported product will be exported to USA, that is, outside the EU?
The product must be packaged as an add-on and must not be installed in any way.
Thank you for the reply.
Good morning,
No, it is not needed; the product must be CE marked only if it is to be placed on the European market.
Greetings from Sicom Testing
buonasera, it is mandatory to put the logo of the company distributing an energiser produced in another country of the European Union? I state that the manufacturer supplies the compliant product. I was wondering if on the packaging in addition to the logo of the company that produces (made by…..) we also wanted it Produced by: name
Thank you
Good morning,
According to the European directives, the distributor is not required to put his logo on the product, on which the manufacturer's information must appear instead.
In the event that the distributor places the product on the market with its own brand, then the distributor assumes the same obligations as the manufacturer and must therefore affix his information on the product.
Greetings from Sicom Testing
Good morning,
As an importer installed on the EU territory, we are obliged to provide our information necessary for the traceability of our medical devices made available on the EU market (the first operator), I had a question about the definition of “accompanying document” the product ?
we can insert our information in the QR code that accompanies the brochure, The catalog…? and it will be enough?
Good morning,
According to our interpretation, the information is also addressed to the final consumer and as such must not be encrypted or require a tool for its reading.
Kind regards
Sicom Test
It's’ a distributor required to indicate the manufacturer's name for each of its products.
Thank you for your reply.
Good morning,
All products subject to CE marking must bear a label indicating the manufacturer, product model and CE mark.
The distributor is obliged to verify that the manufacturer has fulfilled his obligations.
Greetings from Sicom Testing
Good morning.
We are customs operators and we are requested by an Italian company to present a customs declaration for importing from a non-eu country of an equipment that has a declaration of conformity issued in another eu country .
This is a product that the importer will use as professional equipment and will not be marketed. It's’ it is sufficient to have compliance or there are other obligations for the importer? Thank you.
Good morning,
Basically, the EU declaration of conformity is valid throughout Europe, it makes no difference which EU country your petitioner resides in. The important thing is that the person who formed the declaration of conformity is the same person holding the technical manufacturing file and is resident in the?EU. If this is not the case, you will have to create your technical manufacturing dossier and draw up your declaration of conformity by becoming the responsible importer for the products you import into the European community, making sure and ensuring that all the pieces placed on the EU market comply with the requirements of the directives applicable to the product.
Greetings from Sicom Testing
Good morning,
We have an e-commerce site and we sell low voltage products but the product still retains the brand of the original manufacturer. As we are e-commerce sellers, we must issue a CE certificate of conformity signed by us?
Good morning,
If the product has the original manufacturer's marking, you are not required to issue your own certificate of conformity, in your case the obligations of distributors apply:
– check that the product bears the CE marking and that it is accompanied by the required documentation, provide safety instructions and information in a language easily understood by consumers and other end users in the Member State where the material is made available on the market.
– do not place the product on the market if you have reason to believe that the product does not comply with the directives. Moreover, if the material presents a risk, immediately inform the competent authorities.
Greetings from Sicom Testing
Good morning, an item made in china, imported and distributed by a company based in Italy and sold by a small shopkeeper in the province, caused personal injury to my client. The accused article does not have the CE mark and the product packaging merely indicates the importing company and the wording “made in P.R.C.”
In this case, the responsibilities are borne by the importer / distributor? and if so what is the relevant legislation?. Thank you
Good morning,
In this case, the responsibilities lie with the importer / distributor who should not have placed the product without CE marking on the market. The relevant legislation are the European directives that apply to the product (for example if the product is a machine it is 2006/42 / EC – Machinery, if it is a product that connects to the electricity grid, it is 2014/35 / EU – LVD, if there is no directive, general product safety 2001/95 / EC applies)
Kind regards
Sicom Test
Good morning, what are the cases in which the manufacturer's references can be placed on the package, instead of on the plate / label of the product? We are talking about an electric motor intended to be mounted on board an industrial tool.
Thank you
Good morning,
The label / plate, which must always be visible, leggibile e indelebile, it can only be affixed to the packaging if the size or shape of the product does not allow for a legible label to be affixed to the product itself.
Kind regards
Sicom Test
I don't have the CE mark, I want to import medical devices from India to sell them in the EU and my manufacturer has the CE mark. I can use the manufacturer's CE mark?
Good morning,
If the product has the CE mark, the declaration of conformity has been drawn up and all the necessary documentation the product can be placed on the EU market.
As an importer, you have the obligation to verify that:
a) sia stata apposta la marcatura CE al dispositivo e sia stata redatta la dichiarazione di conformità UE di quest’ultimo;
b) the manufacturer is identified and that he has appointed an agent in accordance with the article 11 of the REGULATION (EU) 2017/745;
c) the device is labeled in accordance with the regulations and accompanied by the prescribed instructions for use;
d) il fabbricante, I know about the case, has assigned a UDI to the device in accordance with the article 27 of the REGULATION (EU) 2017/745.
Greetings from Sicom Testing
Ciao,
I would like to know if there are regulations that require manufacturers to provide free training to distributors.
Thank you.
Good morning,
The European directives on products identify the obligations that economic operators have towards end users, market surveillance authorities and the documentation they must produce; there is no indication in the directives regarding the obligation to train distributors.
Greetings from Sicom Testing