The CE marking of conformity
Before placing a medical device on the market the manufacturer must draw up a declaration on conformity in respect of that device and affix the CE marking. The CE marking does not have to be affixed to medical devices intended for clinical investigations, custom-made devices and in vitro diagnostic medical device for performance evaluation. The CE marking does not have to be affixed to medical devices intended for exhibitions, demonstrations, trade fairs, etc. These devices must bear a visible marking indicating that they are not intended to be marketed or put into use. The CE marking must be legible and permanent and affixed to a visible place on the device or its sterile pack, where practicable and appropriate, and on the instructions for use. The CE marking must be accompanied by the identification number of the notified body responsible for conformity assessment if the body concerned has been involved in the conformity assessment procedure.
The CE marking of conformity comprises of the initials C and E, in the following form:
If the marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected. The components of the CE marking must be of the same height, which may not be less than 5 mm. Small products may be exempted from the minimum size.