We actually have a new CEO
Jim Mackenzie
Regardless of the classification of your medical device, you must prepare an EU Declaration of Conformity (DOC) if you sell medical devices in Europe. The elements that should be included in the Declaration of Conformity include:
* Name of the device, including model number and trade name.
* Manufacturer name and address.
* Name of company quality management representative.
* Name and identification number (if applicable) of your Notified Body.
* Name, address and telephone number of your European Authorized Representative.
* Your CE Marking certificate number (if applicable).
* Your conformity assessment route to compliance. List the Annex, classification and rule number (rule number only applies to the Medical Device Directive).
* Standards that have been applied (optional)
*
Name and signature of a senior management representative and date signed.
Explain to your new CEO and draw up a fresh DOC.
(Above details taken from
emergogroup)
See attached for added info about DOC