Who is responsable for my product, if the product is CE-certified?
The New Approach Directives distinguish a number of parties that are responsible or take responsibility with regard to CE Marking:
The manufacturer is any natural or legal person responsible for the design and production of a product with the intention of placing the product on the Community market under his own name. The responsibility of manufacturer is passed to anyone, who changes the intended use of a product in such a way, that the essential requirements come into effect, or who radically changes or rebuilds a product (and makes a new product) with the intention of placing it on the Community market.
The New Approach Directives do not demand that the manufacturer is located within the Community.
The established responsibilities in the Directives are the same for manufacturers located outside the Community, as well as for manufacturers located in a member state.
– Authorised representative
The manufacturer can be located inside or outside the 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 concerning Directives. A manufacturer located outside the Community is not obliged to have an authorised representative, even if this can have certain advantages.
– Importer / person responsible for placing products on the market
The importer established within the Community, who places a product from a third country on the Community market has a restricted, but clearly described responsibility under the New Approach Directives. In some Directives, the importer is referred to as the person responsible for placing products on the market.
- CE Marking
- Certification Experts
- Authorized Representative
- CE Declaration of Conformity
- Competent Body (Notified Body)
- Technical File
- Information on the Product
- USA compliance
- Self certification
- Export to China
- Summary Directives
- Medical Devices