CE-Marking

CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).  It is the manufacturer’s declaration that the product meets the requirements of the applicable EC directives.

The mark consists of the CE logo and, if applicable, the four digit identification number of the Notified Body engaged for the conformity assessment procedure.

The directives requiring CE marking affect many product groups, for implants the group “Active implantable medical devices (excludes surgical instruments)”.