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Document What is a statement of manufacture?

The person who prescribes your dental appliance must offer you a statement of manufacture with full details of the appliance. The statement is like a certificate or warranty and proves that your device has been made to legal standards especially for you. The statement will include:
  • Your name
     
  • Confirmation that the device was custom made for you
     
  • Who prescribed it (and their address)
     
  • Who it was made by (and their address)
     
  • A description of the device
     
  • Confirmation that it meets legal standards
You don't have to take a copy of the statement, it'll be kept on file and you can ask for a copy at any time during the lifetime of the appliance. The dental practice must keep this in a patient's records for a minimum of 5 years (in accordance with the Medical Devices Regulations) however, Dental Protection societies may recommend records are retained for longer periods, typically 11 years.

You won't receive a new statement if your appliance is repaired or refurbished.

You can visit the MHRA website for further information about the Medical Devices Directive.
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