CE Mark the DeviceCE Mark the DeviceCE Mark the DeviceCE Mark the Device
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EU Authorized Representative
December 8, 2023
Declaration of Conformity
December 8, 2023

CE Mark the Device

December 8, 2023

Once the all the previous items are in place:

 

  • Class A sterile, Class B, Class C, or Class D devices must engage a Notified Body to CE Mark the device. The Notified Body will conduct an audit, and upon successful completion, issue a CE certificate. The Notified Body’s 4-digit number will be placed adjacent to the CE symbol.
  • Class A non-sterile devices do not require Notified Body review. Instead, the manufacturer will ‘self-affix’ the CE symbol to the device labeling.
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