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.
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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Good morning,
We are a company operating in a non-EU country with no means of production, only design capabilities. We want to sell a product that we produced in China to EU countries under our own brand.
For this product, the Chinese manufacturer has CE in compliance with directives such as EMC, LVD, PED. But when we want to sell it to EU countries under our own brand, do we take on the role of manufacturer? In this case, do we have to prepare the technical dossiers prepared for all manufacturer directives on our own and obtain approval from an accredited institute 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 product's technical file and draw up the European declaration of conformity.
The EU type examination certificate, issued by a notified body, 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.
Best regards
Sicom Test
Good morning, we are manufacturers of clothing and personal protection for motorcyclists. We design and manufacture in Latin America. We want to know what the process is like from here to obtain European certification. We have high quality standards and a long manufacturing history.
Good morning,
To market protections for motorcyclists and clothing with protections in Europe it is necessary to demonstrate the conformity of the products to the requirements of the European regulation 2016/425 on personal protective equipment.
Best regards
Sicom Test
Good morning,
Does a potential distributor have to fulfill other obligations in addition to those listed above, such as requesting authorizations or registering in some type of register to report the sale of DM? I specify that in this case we are talking about dm, class 1.
Thank you.
Good morning,
The Medical Devices Directive and Regulation do not require distributors to apply for authorizations or register on any kind of register.
For medical devices it is specified that in ascertaining the conformity of the products with the European Community directives the distributor must verify that:
a) the CE marking has been affixed to the device and the EU declaration of conformity of the latter has been drawn up;
(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 particulars appearing on the label are indelible and written so as to be easily legible and clearly understandable to the intended user or patient.
c) for imported devices, the importer has indicated on the device or its packaging or in a document accompanying the device his name, trade name or registered trademark, his registered office and the address at which he can be contacted so that you can be located.
(d) the manufacturer, where applicable, has attributed 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 and, where applicable, the authorized representative and the importer informed of this monitoring and provide them with all the information requested by them.
Good morning, according to the law, a distributor who places a medical device on the market for the first time must enter its data in the register of distributors.
good morning
I would like to import aesthetic technologies from China.
I found a supplier who has already provided me with the CE, which I verified on the European certification body's website and it is real, and I want to buy.
I buy them to resell.
What responsibilities do I face if I put my label on technology, but writing distributed by XXXX company?
Thank you
Good morning,
In your case, the obligations of the importer and distributor apply which for all directives are:
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) Check that the product is supplied with adequate instructions.
3) Withdraw the product from the market if you become aware 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 it with all the 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 this authority.
There may be other obligations depending on the specific directives applied to the product, if the directive relating to medical products has been applied, refer to regulation 2017/745 articles 13 and 14.
Best regards
Sicom Test
Good morning,
What documentation should you produce if you want to resell (as an importer/distributor) products with the CE mark without the manufacturer's name appearing?
Is it possible to issue a CE declaration signed by the importer/distributor?
Thank you.
Good morning,
When an importer/distributor resells the product as his own, i.e. with his own brand, according to European directives he 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, producing the technical dossier of Manufacturing, ensure the conformity of all production.
Best regards
Sicom Test
Good evening!
I am a distributor of one brand of equipment, with a manufacturer in Japan and a representative in Europe of the same brand. However, it is another company that distributes in Portugal and Spain. According to current legislation, who must translate the EC declaration of conformity into Portuguese and Spanish? What data should it contain, i.e. should it only contain data from the manufacturer and representative in Europe or also from 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 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.
Best regards
Sicom test
I have sent the question, where can I get the CE certificate and Declaration of Conformity for MP we purchased from a manufacturer in Switzerland? It is requested by our long-term customer.
lp
Lilijana Jurman
Good morning,
the EU Declaration of Conformity and the technical documentation relating to product certification are the responsibility of the manufacturer, who can be requested to send the aforementioned documentation.
Best regards
Sicom Testing
Good morning, I would like to know if more companies can take the CE in the same country, given that there is no sales exclusivity, or if the second company must necessarily pass through 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 marking is required for the latter, the company must verify its compliance with European directives; after conformity 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 responsible for the CE marking is the manufacturing company; before selling the product, importing and distributing companies must only verify that the documentation for the CE marking is complete and that the declaration of conformity has been completed and signed by the manufacturer (or by a representative based in the European Union if the company is outside Europe). If an importing or distributing company resells the product under its own brand, it is considered a manufacturer.
Greetings!
We have been selling a medical device to facilitate breathing (silicone nasal clip) to some pharmacies for 10 years. We bought them from a Swiss manufacturer, they have the CE mark. They made a translation into Slovenian 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? Do I have to request them from the manufacturer (company) in Switzerland? Greetings Liliana
Good morning,
the European declaration of conformity and the technical documentation of the product can be requested from the manufacturer.
Best regards
Sicom Testing
Two importers in Poland buy goods in Russia and transport them to the EU, can there be 2 importers on the label? Thanks for the reply.
Good morning,
According to our interpretation, 2 importers cannot be indicated on the label as the importer is responsible for the goods he imports; the importer's data is information aimed at the consumer and for each product this reference must be unique; therefore each of the two importers must indicate on the device his name, his registered trade name or his registered trademark and the postal address at which he can be contacted, on the goods he actually imports.
Best regards
Sicom Test
HI.
I have difficulty understanding the following: we are a US based company that produces our products in China, in the EU we don't have a company but we have a tax representative, we import all our goods and then sell on the EU market . So is it correct to list our US company name as an importer of goods into the EU?
A thousand thanks,
Dunya
Good morning,
The regulations establish that the importer must reside within the European Union, therefore it is not expected that a non-EU company appears as an importer on the European market.
Greetings from Sicom Testing
Good morning,
I'm a little confused when it comes to the definition of importer and/or manufacturer. We will import a class IIa medical device from China into the European market. The product is CE marked and has all the required certificates, Declaration of Conformity, ISO 13485, safety data sheets, technical files and EC REP.
The product will be sold as our brand with our design. Our main customer will be pharmacies.
I spoke to the Norwegian Medicines Agency and they told me that my role would be that of importer as long as I didn't make any changes once the product entered Europe. (Which means the manufacturer approved the brand/label etc. and shipped it to Europe)
So, how would you define my role? Importer and/or 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,
Is the CE certificate necessary if the imported product will be exported to the USA, i.e. 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's not necessary; the product must be CE marked only if it is to be placed on the European market.
Greetings from Sicom Testing
good evening, is it mandatory to put the logo of the company distributing an energizer produced in another European Union country? I would like to point out that the manufacturing company supplies the compliant product. I was wondering if on the packaging, in addition to the logo of the company that produces (made by…..), it would also include Produced by: name
Thank you
Good morning,
According to European directives, the distributor is not required to affix its logo to the product, on which the manufacturer's information must instead appear.
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 place its own information on the product.
Greetings from Sicom Testing
Good morning,
As an importer located in the EU territory, we have the obligation 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 ?
can we enter our information in the QR code that accompanies the brochure, catalogue...? and will it be enough?
Good morning,
According to our interpretation, the information is also aimed at the final consumer and as such must not be encrypted or require a tool for its reading.
Best regards
Sicom Test
It is a distributor required to indicate the name of the manufacturer for each of its products.
Thanks for the reply.
Good morning,
All products subject to CE marking must bear a label indicating the manufacturer, product model and CE mark.
The distributor is required to verify that the manufacturer has fulfilled its obligations.
Greetings from Sicom Testing
Good morning.
We are customs operators and we are asked by an Italian company to present a customs declaration for the importation from a non-EU country of 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. Is it sufficient to have compliance or are there 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 its signatory resides in. The important thing is that whoever created the declaration of conformity is the same person who owns the technical manufacturing dossier and is resident in the EU. If this is not the case, he will have to prepare his own technical manufacturing dossier and draft his own declaration of conformity, becoming the responsible importer for the products he imports into the European community, ensuring and guaranteeing 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 sell low voltage products but the product still retains the original manufacturer's brand. Since we are e-commerce sellers, do we need to 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 distributors' obligations apply:
– verify that the product bears the CE marking and that it is accompanied by the required documentation, instructions and safety 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. Furthermore, 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 provincial shopkeeper, caused personal injuries to my client. The accused article does not have the CE mark and the product packaging simply indicates the importing company and the words "made in PRC"
In this case, are the responsibilities 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 reference legislation is 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)
Best regards
Sicom Test
Good morning, what are the cases in which the manufacturer's references can be placed on the packaging, rather than on the product label/tag? 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, legible and indelible, can only be affixed to the package if the size or shape of the product does not allow a legible label to be affixed to the product itself.
Best regards
Sicom Test
I don't have CE mark, I want to import medical devices from India to sell in EU and my manufacturer has CE mark. Can I 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) the CE marking has been affixed to the device and the EU declaration of conformity of the latter has been drawn up;
b) the manufacturer is identified and that he has designated an authorized representative in accordance with Article 11 of REGULATION (EU) 2017/745;
c) the device is labeled in accordance with the regulation and accompanied by the required instructions for use;
d) the manufacturer, where applicable, has attributed a UDI to the device in accordance with Article 27 of REGULATION (EU) 2017/745.
Greetings from Sicom Testing
HI,
I would like to know if there are regulations that require manufacturers to provide free training to distributors.
Thank you.
Good morning,
The European product directives 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