Sir, following the publication of my paper Dental technicians: regulation and quality assurance (BDJ 2010; 210: 25-29) I have been informed by the MHRA that dental bleaching trays intended for a cosmetic purpose do not fall within the remit of the Medical Device Regulations and accordingly the new requirement for providing patients with a custom made statement would not apply to such products.

In light of this, dentists who make bleaching trays in their own surgeries do not need to be registered with the MHRA unless they manufacture other custom made medical devices onsite. This therefore contradicts information contained in the 2010 press release: 'Standards updated on commissioning and manufacturing dental appliances' currently posted on the GDC website regarding this matter and which I referenced in my paper.