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Caution when Purchasing Dental Devices Online - Information Notice

Notice type: Advisory

Date: 09/02/2017

 It has come to the attention of the HPRA that medical devices which may not meet the required performance and safety standards are being purchased over the internet for use in dental practices. The HPRA would like to emphasise that medical devices should be purchased from a reputable source.

All medical devices placed on the Irish market must bear a CE mark. Higher risk medical devices will have a four digit number displayed alongside the CE mark. This four digit number represents the number of the notified body who has certified the product as being compliant with the relevant legal requirements. Devices which are not appropriately CE marked may not be placed on the Irish market.

The HPRA is aware a number of medical devices that are not compliant with medical devices legislation are available for purchase online. Examples include (but are not limited to); contra angle dental hand-pieces, dental intra oral cameras, dental implants (fixation screws), x-ray units etc.

The HPRA has been informed that non-CE marked portable dental x-ray units were purchased for use in Irish dental practises, which when tested were shown to lack sufficient shielding in the x-ray tube. This could give rise to high patient / operator radiation doses. It was also found that such x-ray units did not meet the expected standards of construction and electrical safety.

The HPRA would recommend that dentists, and others in the dental profession, take precautions when purchasing dental devices. Devices should be appropriately CE marked to avoid potential harm to patients and / or users.

Actions To Be Taken:
For recommendation please see
Caution when Purchasing Dental Devices Online - Information Notice

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