Standards on commissioning and manufacturing dental appliances

The General Dental Council (GDC) would like to make registrants aware of a change to the Medical Devices Directive 93/42/EC affecting the provision and manufacture of dental appliances.

This Directive has recently been amended by the European Commission and the regulations implementing these amendments into UK law come into force on 21 March 2010. 

The regulations can be found on the Medicines and Healthcare products Regulatory Agency (MHRA) website, including the changes to the Medical Devices Directive 93/42/EC with respect to custom-made devices.

The GDC will shortly be publishing an updated version of our ‘Standards on Commissioning and Manufacturing Dental Appliances’ guidance which will include the changes to the Directive. This will be made available on our website www.gdc-uk.org

The GDC would also like to take this opportunity to remind all registrants that they are required to find out about laws and regulations which affect their work, premises, equipment or business, and follow them.

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For media enquiries, please contact Moira Alderson on 020 7009 2756 or malderson@gdc-uk.org