BY NOW, MOST OF THE DENTAL TEAM WILL BE AWARE OF THE MEDICAL DEVICES DIRECTIVE AND ITS EFFECT ON THE MANUFACTURER OF DENTAL APPLIANCES SUCH AS CROWNS AND BRIDGES, DENTURES, ORTHODONTIC APPLIANCES, NIGHTGUARDS AND SPINTS. As from 13 June 1998 it will be an offence for anyone to construct dental appliances unless they are complying with the requirements of the Medical Devices Directive. This legislation covers the manufacture of all dental appliances, whether they are made within dental laboratories, dental surgeries, local health authorities or hospitals. It is essential that practitioners can demonstrate that they have satisfied themselves that the laboratories they use are complying in full with the Medical Devices Directive. In reality the only way to do this is to ensure that their laboratories have been third party assessed and have a certificate that demonstrates this.

Monarch Dental Services Ltd were the first Dental Laboratory within the London area to have been assessed as complying in full DAMAS (Dental Appliance Manufacturers Audit Scheme). This scheme was set up by DENPLAN in conjunction with the DENTAL LABORATORIES ASSOCIATION and with the full support of the BDA, the GDC and the GDPA. The aim of the scheme is to give clients confidence that their laboratory systems comply with the legislation and that the laboratories are doing what they claim they are doing. In accordance with the legislation, every dental appliance or restoration manufactured br Monarch Dental Services is now accompanied by a ‘Statement’ declaring that the appliance has been manufactured in accordance with the Medical devices Directive. It is strongly recommended that the ‘Statement is attached bt the dental practitioner to the patient’s dental records. (This does not apply to Sports Mouthguards which come under the Personal