MEDICAL DEVICES DIRECTIVE | CUSTOM MADE
If you’re having what’s called a ‘dental appliance’ fitted as part of your treatment, you can find out more about how and where it was made by asking our dental professionals for a ‘Statement of Manufacture’.
What is a dental appliance?
Dental appliances include most things made outside of your mouth on a model such as crowns, bridges and dentures. They are custom made devices prescribed by our dental professionals.
Each appliance is subject to Medical Devices Directive Regulations, which outlines legal requirements for dental appliances.
‘Statement of Manufacture’
A ‘Statement of Manufacture’ must be offered to you. The statement is like a certificate or warranty, and proves that your device has been made to legal standards especially for you. It is available for every patient for whom we provide an appliance. It confirms: your name, that the device was custom made for you, a description of the device, who made the device and their address, who prescribed the appliance and their address and confirmation it meets legal standards.
If you have not been made aware of your ‘Statement of Manufacture’ please bring this to the attention of a team member. You don’t have to take a copy of the statement. It will be kept on file and you can ask for a copy at any time during the lifetime of your appliance.
Where can I find out more?
If you would like further information about the Medical Devices Directive and how it affects you, visit the MHRA website: www.mhra.gov.uk