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.
Related articles
Good morning,
A company imported electrical equipment into the EU on the basis of valid CE documentation (the certificate and declaration of conformity were issued for 5 years in the EU), carried out all the necessary customs procedures and started selling the goods across the EU. The CE certificate expired in one month. Can you still sell this equipment in the EU until the goods run out? Thank you.
Good morning,
The declaration of conformity does not expire and the goods to which it refers can be placed on the market as long as the standards reported on the declaration are those in force.
Best regards
Sicom Test
Good morning
If I purchase a medical product from a distributor or manufacturer, qualifying myself as a retailer, and resell it to a third party who is not a consumer, do I have any liability in the event of non-conformity of the product? What differences are there between my role as a retailer and distributor?
Good morning,
According to Regulation 2017/745, the distributor is “any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a device available on the market, up to the moment of putting into service;” therefore the retailer is considered a distributor.
Best regards
Sicom Testing
Good morning
We are going to buy an electrical product from a Chinese factory, the manufacturer will put our brand on this product and do the LVD and EMC test reports for our (French) company. We will then be the manufacturer. Will an EU certificate of conformity be required for this product? , what is the mandatory information to appear on the product identification plate? the legislation says: that the contact details of the manufacturer and the importer must be on the product, in the event that the importer becomes a producer will we only have to put the contact details of our company?
Best regards
Laurent
Good morning,
For this product it will be necessary to issue the European Declaration of Conformity on behalf of the manufacturer (your company). On the product it will be sufficient to indicate your data as manufacturer, specifically brand, model, manufacturer name and address, as well as any information relating to the electrical material and the appropriate markings.
In this case your company identifies itself solely as a manufacturer and therefore only your information should be reported on the product.
Greetings from Sicom Testing
Good morning, as far as I understand, devices intended for temporary use in laboratories for tests and development trials may not be CE marked, can you confirm this? What are the regulatory steps to support this? What type of declaration needs to be prepared to be in compliance in these cases?
Thank you. Ferdinand
Good morning,
CE marking is not required for “assessment kits tailored for professionals, intended to be used solely in research and development facilities for such purposes.” (Annex 1 of Directive 2014/53/EU RED and Annex 2 of Directive 2014/35/EU LVD). According to the directives, there is no obligation to prepare a supporting declaration in these cases, however the manufacturer can include its own declaration in the technical documentation which reports the relevant regulatory passages.
Greetings from Sicom Testing
Good morning. The manufacturer's CE declaration must be drawn up in which language? That is, if the product is marketed in Italy, is the manufacturer obliged to draft it in Italian? Can I deliver the CE declaration in English? Thank you.
Good morning,
According to the directives, the EU declaration of conformity must be translated into the language(s) required by the EU country where the product is sold.
Greetings from Sicom Testing
Good morning,
our company commissions the production of products in China and has the brand affixed on site (the product leaves the Chinese factory branded with our logo).
The import is entrusted to an Italian company.
Is our company, which markets the product in Italy, only a distributor (and therefore the obligations fall on the importer) or, having affixed its own brand, is it also a manufacturer? A thousand thanks
Good morning,
According to the directives, when an importer or distributor affixes his name or trademark to the product, he is considered a manufacturer and is subject to the same obligations as the manufacturer. Your company is therefore considered a manufacturer.
Greetings from Sicom Testing
Good morning,
We are resellers and manufacturers of medical devices and also resellers of indoor sanitizers.
Our company is CE, ISO 9001 and 13485 marked by an Italian Notified Body. We import a sanitizer from South Korea which is not a medical device. This product has CE conformity issued only by the non-European manufacturer, therefore, in order to be able to resell it in Italy, this conformity must also be drawn up by the European representative, is this correct? If we were to take on the burden of becoming European representatives, what would it entail? Do we have to contact our Notified Body?
Thanks in advance
Good morning,
In the case of a non-European manufacturer, the declaration of conformity must be drawn up by a European entity, typically the importer.
The authorized representative is a person appointed by the manufacturer by written mandate who is responsible for maintaining relations with the competent national authorities, representing the manufacturer in the act of conserving, and making available, the EU declaration of conformity and the technical documentation, promptly exposing them to following a reasoned request.
In your case, it seems to us that your position is more similar to that of the importer, so your obligations will be those foreseen by the regulations for importers.
For this type of product, it is not necessary to contact the Notified Body.
Greetings from Sicom Testing
Good morning, if you want to import a new product covered by a patent and therefore not covered by a reference regulation (technical or EU legislative), how is CE conformity applied? By similarity to other elements that are closer in application-function?
Good morning,
The directives that apply depend on the characteristics of the product itself, the fact that it is covered by a patent has no influence on the applicable directives.
Best regards
Sicom Test
If I am also an importer as a manufacturer, do I have to indicate my contact details twice on the nameplate (once as a manufacturer and once as an importer)? In this case, is it 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 equipment originating from 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 as "Importer".
Best regards
Sicom Test
Good morning,
How should a company that imports and distributes machines exclusively in Portugal behave in relation to requests from customers and third parties for the declaration of conformity for machines sold for more than 10 years? In other words, the customer claims not to have the declaration of conformity, is the importer obliged to make it available? What if I don't have it?
Thanks in advance.
Good morning,
The directives say that “For ten years from the date on which the electrical equipment was placed on the market, importers maintain the EU declaration of conformity”; nothing is said about importers' obligations after this period. In your case it is advisable to request the documentation directly from the manufacturer of the products.
Greetings from Sicom Testing
Good morning,
I am from a non-EU country and I am trying to sell products in the EU. I have established a subject of European law in the EU. I have an OEM manufacturer who has been authorized to print a brand on the OEM product supported by my established brand agreement. The OEM manufacturer told me that they should do all the certifications within the EU by putting the manufacturer's name on the labels and applications, I think I should apply for the certifications under the responsibility of my European legal entity and thus become the manufacturer” legal". Besides branding rights, there are other legal reasons to force my OEM to allow me to do this.
Good morning,
The responsibility for carrying out all the tests for the CE marking lies with the manufacturer (the person who affixes his own mark on the product), while the responsibilities of the importer and the distributor include verifying the correctness of the documentation for the CE marking.
Best regards
Sicom Test
HI
We are the “manufacturer” for product X imported by our overseas OEM.
Products X (X and X brand address printed on the product)
One of our distributors “A” decides to rename Product X).
As far as I know, Distributor A will become the Manufacturer.
1. Can having two different brands and addresses on the same Product cause confusion for consumers?
2. Is this the right way to relabel the package (rebranding to Brand A) without changing the Brand X address (already printed on the product)?
3. Does the physical product need rebranding?
Thank you
Jack
Good morning,
1. in the event of rebranding, “A” is subject to all the manufacturer's obligations, among these there is the obligation to indicate the manufacturer's name and, if necessary, his address on the product; instructions and labeling must be clear, understandable and intelligible. Technical standards require that 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: "Manufacturers indicate on the electrical equipment their name, their registered trade name or their 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" (Article 6, paragraph 6 of Directive 2014/35/EU LVD). 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 the manufacturer.
Greetings from Sicom Testing
Do we have to appoint an importer for the whole EU or does each of our distributors have to register as an importer?
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, other than the manufacturer or importer, who 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 importers.
Greetings Sicom Testing
Good morning,
When can an importer of electric toothbrushes imported from China obtain manufacturer status?
Good morning,
An importer or distributor is considered to be 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 affected.
Greetings from Sicom Testing
Good morning, I am a distributor of PPE as my products are imported from European companies where I supply them.
I wanted to know if as a distributor I am obliged to include the wording in Italian on each individual product or only on the packaging.
Could you give me some regulatory references?
Thank you.
Simon
Good morning,
The distributors' obligations are defined in article 11 of REGULATION (EU) 2016/425, paragraph 2 obliges the distributor to verify that together with the product there is all the information and markings required by law and that these are in an easily understandable language for consumers and other end users in the Member State where the PPE is made available on the market.
The information required is set out in point 1.4 of Annex II to the Regulation.
Greetings Sicom Test.
Good morning
I am in negotiations with a Chinese manufacturer to sell his product on the European market. we have decided to sell this product under our own brand.
In this case, am I a manufacturer or an importer?
Is there a way to sign a contract with the manufacturer that specifies that the manufacturer remains financially responsible for any future problems that the importer may encounter in the future and that they must necessarily provide technical assistance to resolve the problem?
where can we find this type of contract?
Best regards
Good morning,
according to European directives, when an importer places a product on the market with his own brand he is subject to all the obligations of the manufacturer.
The directives indicate the legal obligations of producers and importers but say nothing about agreements between the parties.
Greetings from Sicom Testing
Good morning,
we are agents of a Chinese company that manufactures glass processing machinery. These machines arrive with a declaration of conformity issued by the manufacturer, but it does not contain the name of the representative and for this reason it is not accepted for Industry 4.0 practices
What are the responsibilities of the authorized representative and what must he receive from the manufacturer? Thank you
Good morning,
According to the European machinery directive applicable to this type of product, the company name and full address of the manufacturer must be indicated in the declaration of conformity and, if applicable, of his agent; if the manufacturer is non-European, the authorized representative must also be indicated in the declaration of conformity.
The authorized representative is any natural or legal person established within the Community who has received a written mandate from the manufacturer to carry out on his behalf, in whole or in part, the obligations and formalities related to the applicable Directive.
Greetings from Sicom Testing
Good morning,
In case I am only distributing equipment from a Chinese OEM, is there a way to free me from certification costs (CE standards)? If I don't change the name of the original supplier, I just add a contact label with my company, for example, does the manufacturer remain the Chinese OEM? And is he therefore the one who has to guarantee CE certification?
Good morning,
CE certification is the responsibility of the manufacturer, who is required to guarantee the conformity of the product to 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.
Greetings from Sicom Testing
good morning, I am a manufacturer of mechanical equipment and I want to turn to a distributor for sales all over the world: is the competence of translating the manuals into the language mine as the manufacturer or the exporter/distributor? Should I refer to those laws?
Thank you in advance
Good morning
As far as the European Union is concerned, 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, 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 in which the material must be made available on the market.
Greetings from Sicom Testing
Good morning,
I purchased CE certified lifting equipment, I cannot receive a duplicate certificate of conformity.
I have to ask the Belgian seller to issue me another certificate or other document. If yes, what type of document, procedure?
Thank you
Good morning,
In this case, the European declaration of conformity of the equipment must be requested from the seller. According to the applicable directives, the seller is obliged to provide it to you.
Greetings from Sicom Testing
Good morning
We import a product from the United States and the manufacturer has issued us the CE declaration of conformity for the product.
Do we have any other obligations as importers?
thank you
Good morning
As an importer you are obliged to indicate on the material your name, your registered trade name or your registered trademark and the postal address at which you can be contacted or, where this is not possible, on the packaging or in a shipping document. accompanying the material.
The contact information must be in a language easily understood by the end-user and the market surveillance authorities.
There is then the obligation to keep the EU declaration of conformity, the technical documentation and the necessary documentation, in paper or electronic format, available to the competent authority for ten years from the date on which the material was placed on the market. to demonstrate the conformity of the material (technical manufacturing dossier).
Finally, as an importer, you are responsible for ensuring that the goods actually comply with European legislation.
Greetings from Sicom Testing