The DLA has recently received queries regarding dental surgeries issuing their own prescriptions for appliances they wish to order from the dental laboratory. Many of the questions focus on the Medical Devices Directive (MDD) and DAMAS requirements, and how the dental laboratory can ensure they remain compliant.

Can a dentist issue its own prescription to the laboratory?

MDD requirements for information supplied by the prescriber (dentist):

The MDD states that a custom made device must be specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. The prescription may also be made out by any other person authorised by virtue of his professional qualifications to do so.

To put it simply, information must be sent by the prescriber (dentist) to the manufacturer (lab), which details the requirements of the appliances to be made. The directive does not extent its scope to specify the prescription appearance or structure, nor does it state that the blank prescription should be initially supplied by the manufacturer (although historically this is what usually happens).

Therefore, as far as MDD compliance is concerned, there are no issues with a dentist providing a laboratory with their own style prescription.

If your dentist has chosen to send in prescription requirements using their own style prescription, you must ensure the following:

• Keep a copy of the dentist’s prescription for your records for 5 years
• Ensure that you continue to have evidence of final inspection and, where appropriate, in-process inspection checks.
• Ensure that completed appliances are returned back to the dentist with a copy of the laboratory’s delivery documentation, which contains the   correct MDD labelling and statement requirements. For example, this could be your current lab ticket which you have completed, or a statement printed from a computer system.

Laboratory documentation which must be delivered with finished appliances

Whether or not the dentist has used their own style laboratory prescription, it is a requirement that the manufacturer must supply a statement with the finished appliance. This statement must also be structured so it can be made available to the patient by the healthcare professional who writes the prescription.

There are no strict guidelines on how the statement should be presented, however, it is compulsory for the following details to be present:

• Name and address of laboratory
• Patient name
• Description of device
• Name of prescriber and, if applicable, address of clinic
• The Statement of Conformity

If you have any questions about laboratory prescriptions, please telephone or email the DLA office.

Categories: Dental Laboratory News