By CE marking the manufacturer declares the conformity of his medical device directives MDD 93/42/EEC of the European Community. Prior to CE marking a conformity assessment described in the directives must be completed for each device.
Only 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 classed as Is, Im, IIa, IIb, III – sales in Europe is allowed after CE registration with the relevant competent authorities.
Medical devices must be registered with the Competent Authorities before being placed on the market.
DENTEQ as your EC Representative will perform this national product registration as part of our Authorized Representation Services.