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.
The directive has been amended by the European Commission and comes into force on 21 March 2010 in the UK.
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 at http://www.mhra.gov.uk/Howweregulate/Devices/RevisionstothemedicaldevicesandAIMDDirectives/index.htm
The GDC will be publishing an updated version of its 'Standards on Commissioning and Manufacturing Dental Appliances' guidance which will include the changes to the Directive.
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Medical Devices Directive changes. Br Dent J 208, 247 (2010). https://doi.org/10.1038/sj.bdj.2010.267
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DOI: https://doi.org/10.1038/sj.bdj.2010.267
