§ Mr. Frank FieldTo ask the Secretary of State for Health what plans his Department has to outsource custom-made dental devices to(a) Turkey, (b) Hungary, (c) China and (d) the Philippines. [133244]
§ Ms Rosie WintertonCustom-made dental appliances are manufactured to the written prescription of the dentist responsible for the case in question. The choice of manufacturing laboratory is a matter for local decision. All dental laboratories in the European Union are registered with the competent authority, which in the United Kingdom is the Medicines and Healthcare products Regulatory Agency.
Manufacturers of custom made appliances from outside the European Union are required to designate an authorised representative within the European Union, who must register with the competent authority where they have their registered place of business. The manufacturer must meet the relevant requirements of the Medical Devices Directive (93/42/EEC) and must meet the same standards as devices manufactured within the European Union.