Things you should know about your legal responsibilities Leave a comment

Following from the commentary on page 1.

Standard 1.9 of Standards for the Dental Team states that:
‘You must find out about laws and regulations affecting your work and follow them’.

 If you commission and manufacture dental appliances you must comply with the Medical Devices Directive 93/42/EC. Compliance with this is a legal requirement and failure to comply is a criminal offence.

Registrants who manufacture dental appliances mainly outside of the mouth (for example- fixed bridges, bleaching trays, crowns, splints, retainers, etc.) If you make a dental appliance, whether you are a dental technician, dentist, or any other registrant, you must understand and comply with your legal responsibilities as “manufacturer” under the Medical Devices Directive 93/42/EC. This includes the legal requirement to register with the Medicines and Healthcare products Regulatory Agency (MHRA).

You must provide a statement of manufacture, which gives the following information when dispatching a dental appliance:

 • the name and address of the manufacturer, and if outside the EEA their authorised representative,

 • data allowing identification of the device in question,

 • a statement that the device is a Custom-made Dental Appliance and intended for exclusive use by a particular patient, together with the name of the patient,

 • the name of the practitioner or other authorised person who made out the prescription and, where applicable, the name of the practice concerned,

 • the specific characteristics of the product as indicated by the prescription,

• a statement that the device in question conforms to the essential requirements set out in Annex I of the Medical Devices Directive 93/42/EC and, where applicable, indicating which essential requirements have not been fully met, together with the grounds.

 Registrants who arrange for dental appliances to be made If you prescribe a dental appliance to be made by a person in the UK who is not a registered dental technician you may put your registration at risk.

Equally, you may put your registration at risk if you receive a dental appliance made in the UK by a person who is not a registered dental technician.

Registrants who sub-contract or prescribe dental appliances to be made outside the UK

 If you decide to either sub-contract the manufacture of a dental appliance, or use a dental laboratory or agent which sources dental appliances outside the UK your choice not to use a UK-registered dental technician puts a particular responsibility on you.

You will be held professionally accountable for the safety and quality of the appliance because you have chosen not to sub-contract or issue the prescription to a registered dental technician who would otherwise be accountable him or herself.

You take on the dental technician’s responsibilities for the appliance and the GDC will hold you accountable for your decision.

You should take appropriate steps to discharge the extra responsibilities that come with this decision.

These include a responsibility to ensure that the manufacturer or their authorised representative1 has complied with all relevant obligations in the Medical Devices Directive.

If a dental appliance or any part of it has been manufactured outside the EU, the name and address of the manufacturer should be disclosed to the patient.

Registrants providing patients with a dental appliance The Medical Devices Directive 93/42/EC requires that the statement of manufacture is available to the patient for whom the dental appliance is made. The patient can request this at any time during the lifetime of the appliance.

You must inform patients of the existence of the statement and offer them a copy. You must record whether or not they choose to take a copy of it.

If the patient does not choose to take a copy of the statement, you must keep the statement for the lifetime of the device in case it is requested at a later date.

 Effective from 30 September 2013 General Dental Council 37 Wimpole Street London W1G 8DQ