Implications for Dental Practices Following the Change to the Medical Devices Directive

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Amendments to the Medical Devices Directive: The impact on Dentistry

Dental appliances, which are made for a specific patient, are ‘custom-made devices' under the Medical Devices Directive 93/42/EC. This Directive has recently been amended with the changes taking effect from 21 March 2010. These changes are of immediate relevance to dental registrants.

GDC guidance
The GDC has produced new guidance following the changes: Standards on Commissioning and Manufacturing Dental Appliances.

Custom-made devices statement
Following the recent changes the patient must now be advised that a statement about their laboratory work is available on request. This statement is over and above the previous statement provided by the laboratory to the prescriber of the device.

The statement must be drawn up by the manufacturer or his authorised representative and should contain the following information:

• The name and address of the manufacturer;
• Data allowing identification of the device in question;
• A statement that the device is intended for the exclusive use by a particular patient, together with the name of the patient;
• The name of the authorised person who made out the prescription and, where applicable, the name of the clinic concerned;
•  The special 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 1 of the Directive and, where applicable, indicating which essential requirements have not been fully met, together with the grounds.

The Medical and Healthcare Products Regulatory Agency (MHRA) have produced examples of statements for custom-made dental products. These are available from the MHRA website and by clicking here for Example A and here for Example B.

Special characteristics of the products as indicated by the prescription
The prescription should provide enough detail to allow the team member to be left in no doubt as to the work that has to be undertaken, its nature and extent.

An open dialogue between the prescriber and the manufacturer of the dental appliance should be encouraged, as this can benefit the patient by enabling changes to the prescription to be incorporated. For example, an undercut may be readily apparent to the manufacturer when it was not detected by the prescriber. Simply picking up the telephone to the prescriber/manufacturer can help to resolve treatment dilemmas.

Informing patients
The registrant who prescribes and fits the appliance must ensure that the patient is informed about the statement and makes the statement available, if requested. Practice managers may wish to consider placing posters in the waiting room to reinforce verbal advice about the statement provided by the clinician at the end of treatment. If the clinician informs the patient verbally at the end of treatment a contemporaneous record of the discussion should be made in the patient's records.

Practices may also wish to consider amending receipts to include information about the statement. If the practice is relying on a note on the receipt to impart the information then the practice should consider what arrangements are in place for informing patients who are exempt from any charges.

Retention of the statement
If the patient does not request the statement it should be retained for the lifetime of the appliance as part of their dental records. If the patient requests the statement, the patient should be asked to sign for the statement and the signature retained within the patient's dental records.

Criminal sanction
If a registrant fails to comply with the Regulations, which implement the Directive, they will be vulnerable not only to challenge by the General Dental Council but they will also leave themselves vulnerable to criminal prosecution. A successful prosecution under the Medical Devices Regulations carries a maximum penalty of a £5,000 fine per offence or six months imprisonment.

Registrants may be concerned that if they are challenged by the Medical Devices Complaince Unit, which has responsibility for enforcement of the Medical Devices Regulations that they will not be indemnified, as it is a criminal matter. One advantage of the flexibility offered by Dental Protection's discretionary indemnity is that the discretion can be exercised to assist member's facing a criminal investigation arising under the Medical Devices Regulations.

Post-market surveillance
The changes in the Directive also impose a duty on manufacturers to set up a post market vigilance system, including reporting to the MHRA.