Information for Dental Nurses
The GDC President, Hew Mathewson issued a statement that:

"Taking impressions to a dentist’s prescription, and making bleaching trays to a dentist’s prescription, are within the scope of additional skills for dental nurses”.

' ...A dental nurse who takes impressions and constructs bleaching trays is creating a custom-made device as defined by the Medical Devices Directive, and this activity imposes various legal requirements involving the dental nurse and his/her employer, with regard to registration with the Medical and Healthcare Products Regulatory Agency, and the documentation and quality assurance in relation to each medical device constructed...' (Position Statement on Tooth Whitening by DCPs, July 08).

'Custom-made' means that the product is manufactured specifically in accordance with a written prescription of a duly qualified medical practitioner or a professional user and it is intended for the sole use of a particular patient. Manufacturers of custom made devices need to ensure their products meet the relevant requirements and register.'

Further information on Medical Devices is available from MHRA website [ Click Here ]

MHRA have produced specific regulatory guidance for manufacturers of these products. See Guidance Note No 9 Guidance Notes for Manufacturers of Custom made Devices [ Click Here ]