What does CE marking mean for medical device manufacturers?
The CE mark stands for "Conformité Européenne" which means "European Conformity". By CE marking the manufacturer declares the conformity of his medical device, in-vitro diagnostic medical device or active implantable medical device with the relevant directives MDD 93/42/EEC, IVDD 98/79/EEC and AIMDD 90/385/EWG of the European Community. Prior to CE marking a conformity assessment described in the directives must be completed for each device.
Only medical devices or in-vitro diagnostic medical devices within the scope of these directives can be CE marked. CE marking must not be applied to products that do not fall under the directives.
Once a medical device is CE marked - either by self-declaration for class I medical devices or in cooperation with your Notified Body for devices classes Is, Im, IIa, IIb, III or AIMD - sales in Europe is allowed after CE registration with the relevant competent authorities. MedNet as your EC Representative will perform this national product registration as part of our Authorized Representation Services.