Responsibilities of the manufacturer, importer, distributor and Authorised Representative regarding CE-marking of products.
The manufacturer is responsible for the CE Marking, if the manufacturer is not located within the European Economic Area (EEA), there must be a responsible party appointed by the manufacturer with the European Economic Area EEA. This responsible party must have access to the technical file if there are questions from authorities or surveillance bodies. The appointed responsible third party can be an Authorised Representative, the importer or distributor who can be appointed to take on this responsibility. It is important that the importer (the person responsible for placing the product on the market) is capable to present the surveillance bodies with an EC Declaration of Conformity and have access to the Technical File. This importer (person responsible for placing the equipment or product on the market) will be responsible if the manufacturer is not located within the European Community and if he has not appointed an third party such as an Authorised Representative in Europe.
Responsibilities of the manufacturer
The manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and places it on the market under his own name or trademark.
The responsibilities of the manufacturer apply also to any natural or legal person who assembles, packs, processes or labels ready-made products and places them on the market under his own name or trademark. Further, the responsibility of the manufacturer is placed on any person who changes the intended use of a product in such a way that different essential or other requirements will become applicable, or substantially modified, or further re-builds a product (thus creating a new product).
The manufacturer is responsible for designing and manufacturing the product in accordance with essential or other legal requirements laid down by the relevant European Union harmonisation legislation and for carrying out conformity assessment in accordance with the procedure(s) laid down by the Union harmonisation legislation.
If an importer modifies a product to the extent that the intended use or compliance with the applicable requirements may be affected or supplies the product under his name or trademark, then he is to be considered the manufacturer and must undertake all the obligations for on the manufacturer. Accordingly, he must ensure that the product complies with the applicable European Union harmonisation regulations and that the appropriate conformity assessment procedure has been carried out so that the CE-marking can be legally affixed to the product.
Responsibilities of the Authorised Representative
The manufacturer can be located within or not within the European Community. In both cases, the manufacturer can appoint an Authorised Representative to act on his behalf for the execution of certain tasks established in the CE-marking Directives such as having access to the technical file, contact point for authorities, customs or surveillance bodies.
In compliance with the European Union harmonisation regulations , to be able to act on behalf of the manufacturer, the Authorised Representative must be established inside the European Union. Commercial representatives of the manufacturer (such as authorised distributors or agents), are not to be confused with the authorised representative in the meaning of European Union harmonisation regulations.
An official legal Authorised Representative contract must be compiled in which the tasks and responsibilities of the Authorised Representative are clearly described. Tasks which can be carried out by the Authorised Representative can include access to the EC declaration of conformity, access to the technical file, co-operate with national surveillance bodies or competent national authorities.
The Authorised Representative who is appointed by a manufacturer may be an importer or a distributor in the meaning of Union harmonisation regulations, if this is the case he must also fulfill the obligations of the importer or distributor.
Responsibilities of the importer established in the European Union
The importer or responsible party established within the European Community, who places a product from a country not situated in European Union has a restricted, but clearly described responsibility under the regulations.
The importer must ensure that the manufacturer not established in the European union has correctly fulfilled his obligations. The importer is not a simple re-seller of products, but has a key role to play in guaranteeing the compliance of imported products.
Before placing a product on the market the importer must ensure that the appropriate conformity assessment procedure for the product has been carried out by the manufacturer. The product should be supported by the correct compliance documentation such as EC Declarations. Further the importer should verify if the manufacturer has drawn up the technical documentation, if required it must be made available to the competent authorities, affix the relevant conformity marking (e.g. CE-marking), also accompanied by relevant product instructions and safety information in a language where the product will be put into use.
The contact data of the importer must be on the product or its packaging, this with regard to traceability.
Role as Importer
The importer established within the Community, who places a product from a country not situated on the Community market has a restricted, but clearly described responsibility under the New Approach Directives. Certain Directives indicate that, the importer is referred to as the person responsible for placing machinery on the market.
The importer should not have a mandate, or a preference relation with the manufacturer in the way the Authorised Representative has. The importer must ensure that contact with the manufacturer can be made, in order to satisfy his responsibilities.
In some situations, the person who is referred to as importer must be capable of undertaking the responsibilities of the manufacturer, this means ensuring that the product meets the essential requirements and that the correct conformity assessment procedure is applied.
When the importer assembles, packages, processes or labels ready-made products with the intention of putting these on the Community market under his own name, or when he radically changes the intended use of the product, he can be regarded as the manufacturer in the sense of the New Approach Directives.
If the importer is regarded as manufacturer, he is obliged to ensure that a product that is brought on the market in the EEA meets the essential requirements in accordance with the applicable Directive(s).
Role of Distributor
The distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.
Retailers, wholesalers and other distributors in the supply chain are not required to have a preferential relationship with the manufacturer like the Authorised Representative. A distributor acquires products for further distribution either from a manufacturer, from an importer, or from another distributor. Distributors should be aware of the CE-marking regulations and which products should be CE marked, use of language, labeling requirements, users instructions.
The distributor must be able to identify the manufacturer, his authorised representative, the importer or the person who has provided him with the product. If required the market surveillance authority in its efforts to obtain the information can request the distributor to co-operate with them.
A distribution contract must be compiled which must comply with the conditions of the European regulations
Certification Experts service and support
Certification Experts performs entire certification processes for manufacturers, producers, importers and designers who want to sell and trade their products on the European market. Our experts assists companies to ensure that their products meet the applying European safety requirements. For questions about your responsibility regarding CE-marking or other questions, please contact us using one of the following methods.
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manufacturer, importer, distributor and Authorised Representative regarding CE-marking. Certification Expert acts as European Authorised Representative for many producers and export companies not situated in the European Union.