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UK guidance on custom dental ware

This article was originally published in Clinica

Executive Summary

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.

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