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 retail store for electronic products.
We also buy in Italy products manufactured in other parts of the world. Always from Italian distributors.
Are we required to have certifications for items in store?
According to the European directives you are distributors, therefore your obligations, for each product, are:
- verify that a product 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 product is to be made available on the market.
- that the manufacturer and the importer have indicated their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on the packaging or in a document accompanying the product.
-a type, batch or serial number or any other element allowing its identification is affixed to the product or, where the size or nature of the product does not allow this, that the required information is provided on the packaging or in a document accompanying the product.
-ensure that, while the product is under your responsibility, storage or transport conditions do not jeopardise its compliance with safety objectives.
-if you believe that a product is not compliant, do not place it on the market and notify the manufacturer or importer and the market surveillance authorities.
Best regards
Sicom Test
Good morning,
we are distributors of a paper company, can we indicate only our name on the product?
Good morning,
The manufacturer and (for products imported from non-EU markets) the importer must be indicated on the product.
If you indicate only your name on the product you will be considered as the manufacturer and will have responsibility for the product as if you were the manufacturer.
Best regards
Sicom Test
Good morning, thanks for the detailed article.
We are a company that produces castom electronic control boards at the request of our customers.
These are therefore products that are not useful if placed directly on the market but are specific for the control of our customers' machines. Do we have any type of obligation regarding CE certification or are these delegated to our customers who are manufacturers of the finished product placed on the market? Thank you
Good morning,
Electronic boards are considered electrical material and therefore fall under the Low Voltage Directive (LVD) if they are used at a nominal voltage between 50 and 1 000 V in alternating current and between 75 and 1 500 V in direct current, therefore they must be CE marked; if they work at lower voltages you still have the obligation to ensure that the product is safe as it falls under the General Product Safety Directive (GSPD).
Best regards
Sicom Test
Hi, if I decide to import 3D printers from the Chinese market, to resell in Europe, the supplier has sent me all the necessary compliance, do I still have to do other documents?
Good morning,
If you import products from markets outside the European single market you are subject to importer obligations:
-Ensure that the manufacturer has prepared the technical documentation, drawn up the European Declaration of Conformity, that the CE marking is affixed to the appliance, and that the latter is accompanied by the required documents (e.g. instructions).
– indicate on the device your name, your registered trade name or your registered trademark and the postal address at which you can be contacted. The contact information must be in a language easily understood by the end-user and the market surveillance authorities.
– ensure that the appliance is accompanied by instructions and information in a language that can be easily understood by consumers and other end users.
– ensure that, while an appliance is under your responsibility, storage or transport conditions do not put its compliance at risk.
– withdraw products from the market that are found to be non-compliant
– For ten years from the date on which the appliance was placed on the market, keep the EU declaration of conformity available to the market surveillance authorities; further ensure that, upon request, technical documentation will be made available to these authorities.
– Make sure that the manufacturer has indicated his name, registered trade name or registered trademark and the postal address at which he can be contacted or, where this is not possible, on the packaging or in a document accompanying the product device. The address indicates a single point where the manufacturer can be contacted. The contact information must be in a language easily understood by the end-user and the market surveillance authorities.
Best regards
Sicom Test
Good morning,
We are purchasing medical device gloves from a non-EU company and we have asked our supplier to make an extension of his certification, issuing the arrested form B in our name but using the tests performed by him. Our brand, code and commercial name of the product will appear on the packaging. Will we be manufacturers and must we put the manufacturer's symbol and our company data on the packaging or is it sufficient to write that the product is imported, always indicating our company name?
Good morning,
If you put your brand on the product you will be considered a manufacturer and you will have all the duties and responsibilities required for manufacturers by the European directives and regulations on medical products.
Best regards
Sicom Test
Good morning
A manufacturer from a non-EU country supplies me with a customized product.
The manufacturer does not have an authorized representative and they are the importer of the product.
Furthermore, I make it available on the market within the EU with my brand, from what is reported in the 'blue guide' I become the Manufacturer and I have to draw up the EU declaration of conformity.
Should the non-EU manufacturer be included in the EU declaration and then must it have my signature?
Good morning
In the EU declaration of conformity, only the signatory of the declaration of conformity must be indicated as Manufacturer.
Best regards
Sicom Test
Good morning
I would need advice:
I would like to purchase an immunofluorescence analyzer from the Chinese manufacturer. And I want to customize it (add my logo, my company address and contact details on the products and packages).
The manufacturer has CE certification. Can I use the CE mark on the packaging. Do I also have to mention the manufacturer's name and address on the packaging or it is not necessary. I want to sell the products in Türkiye. What document is required if I do not mention the manufacturer's name and address on the package?
Good morning,
When purchasing from a Chinese manufacturer, if you keep the manufacturer's label, you have the duty to put the company name and your contact details as the importer.
If you remove the indication of the Chinese manufacturer, you will be considered as a manufacturer and you will have all the obligations of the manufacturers:
– you must prepare a technical documentation package for the product
– draw up the declaration of conformity
– ensure the conformity of all products placed on the market
– ensure that each piece is accompanied by instructions
– keep all documentation available to market control authorities
Best regards
Sicom Test
Good morning, and if the product is sold in Europe, do we have to indicate the name of the manufacturer and his address or simply put the name of the importer?
Good morning,
For products placed on the Union market from third countries, the trade name and postal address of both the manufacturer and the importer must be indicated.
Best regards
Sicom Test