Can a registered and qualified dental technician, by virtue of their qualification, manufacture appliances to their own prescription and place them on the market?
No. Custom made devices are defined in Regulation 5 of the MD Regulations as being manufactured in accordance with a prescription of a duly qualified medical practitioner or professional user. As dental technicians are not currently permitted to undertake the practice of dentistry as defined in Part IV of the Dentists Act 1984 they may not prescribe, fit, insert or fix appliances , it would be a breach of the that Act and the Medical Devices Regulations to place a custom made device on the market without a prescription from a dentist.
Related Questions
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