Sample European CE Declaration of Comformity for Medical Devices
Regardless of the classification of your medical device, you must prepare an EU Declaration of Conformity (DOC) if you sell medical devices in Europe. A copy of your Declaration of Conformity must be kept with your Technical File. A sample Declaration of Conformity is shown below. You do not need to copy this format, but the information must be complete. Obviously, you must insert the name, address and phone of your company's Authorized Representative for Europe where indicated below. The Emergo Europe name is shown for demonstration purposes only and can only be used by Emergo Authorized Representation clients.
If you would like to learn about Emergo Group's Technical File preparation or Authorized Representative services, please contact us.
