CE Marking

Medical Devices sold within the EEA Countries, must meet the Medical Device Directives (MDD's) and bear the "CE Mark" as evidence of compliance. Requirements for applying the CE Mark vary, depending on the classification of device being sold. Devices are classified according to associated risk with Class I as the lowest risk and Class III as the highest. Requirements for Class I devices are less stringent than the requirements for Class IIa, IIb and Class III.

Spectre Solutions can help you in meeting the requirements of the MDD's and applying the CE Mark. We have experience in classifying the device, choosing the best method of meeting the requirements and developing the necessary documentation.

Key Benefits

    Registrar selection.
    Device classification.
    Technical files and declarations of conformity.
    Adverse event reporting requirements.
    Guidance on translation requirements for device labeling.
    Conformity Assessment Route Selection.