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). The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States.
The CE marking 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 involved in the conformity assessment procedure.
Why CE Certification for Medical Products?
CE Certification of medical devices allows you, together with the necessary examinations proving compliance of your medical devices, to further exploit potentials in existing markets and to enter into new national and international markets. Additionally beyond that, risks and liability in your chosen markets will be weakened.