Q. I am worried by two pieces of advice from the GDC about bleaching. Their guidance on Scope of Practice (November 2008) states that taking impressions to a dentist’s prescription, and making bleaching trays to a dentist’s prescription, is within the scope of additional skills for dental nurses.

Their position statement on tooth whitening (July 2008) advises that 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.

Do both the dentist and the dental nurse who is making the bleaching trays need to be registered with the Medical and Healthcare Products Regulatory Agency (MHRA) or just the practice?

A product is defined as a medical device by the MHRA if it complies with the definition of a medical device under the Medical Devices Directive (MDD) 93/42/EEC Article 1, Clause 2a. For a product to be classified as a medical device it must be "intended to provide or assist with the diagnosis, monitoring, prevention or treatment of a medical condition".

Tooth whitening or bleaching trays are not normally produced for a medical purpose, but are designed to provide a cosmetic improvement. It follows then that if no medical claims are being made for the bleaching trays, then the MHRA would likely consider that they fall outside of the Medical Devices Directive and therefore the product would be exempt from registration. If, however, he trays had a difference purpose (i.e., for the treatment of an occlusal or TMJ problem) then they would almost certainly have a medical purpose and registration would be necessary.

In terms of registration, it would be the practice that would need to register rather than the individual who was making the trays themselves. That is of course assuming that that individual was an employee of the practice, rather than a self-employed individual. Even then it is unlikely that the MHRA would feel that individual registration was required.

You can find the MHRA guidance notes for the manufacture of dental devices here

The Agency is more than willing to answer questions by telephone or email back to you. So even though trays constructed solely for bleaching would seem to fall outside the definition of a medical you may wish to contact them directly if you have any concerns about any additional uses for such trays.