Medical Devices

A medical device, as defined in the EU Medical Device Regulation (EU) 2017/745 [1] is “any apparatus, appliance, software, material, or other article which is intended by the manufacturer to be used for the diagnosis, prevention, monitoring, or treatment of illness or disability.” Following the Brexit agreement, this European law was not retained in Great Britain, and was replaced with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) [2], and associated directives (e.g. Directive 93/42/EEC on medical devices (EU MDD)) [3].

The NHS Scotland Turas platform has a number of learning resources on medical devices regulations, directives and medical devices for health and social care staff.

Within dentistry, medical devices are defined as dental materials, instruments and equipment. Manufacturers of medical devices must adhere to the Medical Devices Directive (93/42/EEC) [3] to ensure devices have a UKCA or CE mark, that signifies and confirms they are safe to use. Within the UK, the CE mark is administered and enforced by the Medicines and Healthcare products Regulatory Agency (MHRA).

Custom-made dental devices (e.g. dentures, bridges, whitening trays) made by a dental laboratory under prescription from a dentist are also classified as medical devices. You should confirm that the dental laboratory you use is registered with the MHRA and follows the manufacturing procedures set out in the Medical Devices Directive (93/42/EEC) [3]. Dental devices produced within the practice (e.g. milled ceramic work, retainers) are also defined as medical devices, and the dental practice must be registered with the MHRA.

For a medical device produced either by a dental laboratory or in practice, a ‘patient statement’ must be provided to the patient along with the device. The General Dental Council provides further information, including a Statement of Manufacture template that gives details of the items that should be included in the patient statement.

Sources of information