Dental materials, instruments and equipment are medical devices and should be CE marked. Manufacturers must conform to the Medical Devices Directive (93/42/EEC) and devices must carry a CE mark to indicate that they satisfy EU quality requirements and are fit for their intended purpose.
As a dentist, you are likely to provide custom-made medical devices for your patients – items made by a dental laboratory to your written prescription. These devices are covered by the Directive, so you must check with your laboratory that they are registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and follow the required manufacturing procedures; a statement of manufacture confirming this should accompany each custom-made device.
The MHRA is the competent authority that administers and enforces the law on medical devices in the UK. It has a range of investigatory and enforcement powers to ensure the safety and quality of all medical devices placed on the market and used in the UK.
Key learning points
This advice should help you understand how medical devices are regulated in the UK and the implications for your practice and your patients. It explains:
- The need for manufacturers to have medical devices assessed by a notified body and carry a CE mark to indicate that they satisfy EU quality requirements and are fit for their intended purpose
- How to report a fault with a medical device
- Your obligations when providing custom-made devices for your patients
- The checks that you need to make of the laboratory manufacturing the device
- The information that you must make available to patients.