Can a qualified dental technician sign off finished appliances as fit to be placed on the market?
Dental technicians can sign off finished appliances as fit to be placed on the UK market as long as they comply with the requirements of the Medical Devices Regulations as they apply to custom-made devices. This includes making a statement that accompanies the individual device which confirms that it conforms to the essential requirements specified in Annex I of the Medical Devices Directive 93/42/EEC which are implemented into UK law by the Regulations.
Related Questions
- When manufacturing appliances to a dentists prescription, who takes responsibility for placing the appliance on the market? Is it the dental laboratory or the dentist?
- Can a registered and qualified dental technician, by virtue of their qualification, manufacture appliances to their own prescription and place them on the market?
- Can a qualified dental technician sign off finished appliances as fit to be placed on the market?
