GDC issues updated rules over lab work
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- Published: Monday, 12 April 2010 23:14
- Written by News Editor
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| The General Dental Council (GDC) has published an updated version of its Standards on Commissioning and Manufacturing Dental Appliances guidance. This follows a change to the Medical Devices Directive 93/42/EC affecting the provision and manufacture of dental appliances. This includes providing a statement of manufacture and places extra responsibilities on those who send their work overseas to be made.
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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.
This includes providing a statement of manufacture with the following information when dispatching a dental appliance:
- the name and address of the manufacturer, and if outside the EU 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 authorized 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.
These are legal requirements. The GDC expects you to fulfil these responsibilities and will hold you accountable for doing so.
If you arrange for dental appliances to be made in the UK, you are professionally responsible for issuing the prescription to and receiving the appliance from a UK-registered dental technician. If you prescribe a dental appliance to be made by a person in the UK who is not a registered dental technician you are liable to face a GDC fitness to practise inquiry. Equally, you may face a GDC fitness to practise inquiry if you receive a dental appliance made in the UK by a person who is not a registered dental technician.
When making the decision 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. This is 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.
The GDC expects you to 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 representative has complied with all relevant obligations in the Medical Devices Directive. Further, 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.
For further information go to the GDC website www.gdc-uk.org
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