UK guidance on custom dental ware
This article was originally published in Clinica
The UK's Medicines and Healthcare products Regulatory Authority (MHRA) has updated its guidance notes for manufacturers of custom-made dental appliances. The 12-page guidance notes cover: the definition of dental appliances as custom-made devices; the articles of the Medical Devices Directive (MDD) that refer to custom-made devices; the annex VIII statements concerning devices for special purposes; and the relevant MDD essential requirements. There is also a summary of the guidance notes regarding the activities to be undertaken by dental laboratories to meet the requirements of the MDD.