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Document How long do we need to keep a statement of manufacture with a patient's records?

You must keep a statement of manufacture in a patient's records for a minimum of five years (in accordance with the Medical Devices Regulations) however, Dental Protection societies may recommend records are retained for longer periods, typically 11 years.
You don't need to issue a new statement if you repair / refurbish an existing appliance.
Click here for further information about the Medical Devices Directive.
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