Gain market access in Europe with CE marking approval
CE marking approval and certification
A medical device can only be sold in Europe with a CE mark. By placing the CE mark on a product, the manufacturer declares that their product complies with all applicable Directives and Regulations. As a full scope Notified Body for medical device CE marking, we can issue device-specific CE certificates and Declarations of Conformity for your Class I sterile or measuring, Class IIa, Class IIb, or Class III device.
Class I devices that are not sterile or complete a measuring function do not require a certificate from a Notified Body, these products are self-certified by the manufacturer.