The responsibility with regards to the conformity assessment depends on the procedure applied by the manufacturer. In general, the manufacturer should take all necessary measures to ensure that the manufacturing process is performed in a way that the products are meet the requirements for affixing them with a CE Marking and to compile a Technical File and an EC Declaration of Conformity.

Depending on the Directive, it may occur that the manufacturer has to put his product at the disposal of a third party (Notified Body) to have the product tested and certified, or to have his quality system certified.