MDD CE Mark.

ANNEX XII – CE MARKING OF CONFORMITY

 

Medical Devices Directive – explained >>>
How Medical Devices are regulated in Europe >>>
 

The CE conformity marking shall consist of the initials ‘CE’ taking the following form:

 

MDD ANNEX XII - CE MARK OF CONFORMITY

MDD ANNEX XII – CE MARK OF CONFORMITY



 
If the marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.
The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.
 

This minimum dimension may be waived for small-scale devices.

 
MedicalDeviceValidation-small_03
Training presentation on Medical Device – Validation. Regulation. Classification. FDA & “CE” requirements. … …