Who is responsible for the correct use of the CE mark?

The manufacturer is in principle responsible for the CE Marking, but if the manufacturer is not located within the European Economic Area (‘EEA’), the authorised representative or, in some cases, the importer can take on this responsibility. The New Approach directives and/or regulations distinguish a number of parties that are responsible or take responsibility with regard to CE Marking.

Manufacturer

The manufacturer is responsible for the design and production of a product with the intention of placing the product on the 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.

The New Approach DiCE-logo1rectives/Regulations does not demand that the manufacturer is located within the European Union. The established responsibilities in the Directives/Regulations are the same for manufacturers located outside the Union, as well as for manufacturers located in a Member State.

Authorised Representative

The manufacturer can be located inside or outside the EEA. 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/regulations. A manufacturer located outside the European Union is not obliged to have an Authorised Representative, only manufacturer of medical devices are obliged to apoint an EC Rep.

Importer

The importer established within the European Union, who places a product from a third country on the Union market has a restricted, but clearly described responsibility under the New Approach. In some (older) legislative acts, the importer is referred to as the person responsible for placing products on the market.

Distributor

Distributors also have obligations and are a key role in the context of market surveillance. Along with manufacturers and importers, distributors are part of the economic operators who are subject to specific obligations. The distributor is seen as a natural or a legal person in the supply chain.