Medical Devices

Medical devices are not regulated by the Human Medicines Regulations (HMR) 2012.

Medical device packaging must include the UKCA mark or CE mark. The packaging does not include a Product License (PL) number because they are not medicines.

Examples of medical devices used in dentistry include some chlorhexidine mouthwashes (for example Curasept), saliva replacement products, and some fluoride varnishes (for example Fluor Protector S).

Supply of medical devices (such as artificial saliva preparations) is not regulated by HMR 2012 and does not require a prescription. They may be sold directly from a dental practice. It is good practice to have a local policy or procedure for staff to follow. Protocols should address record keeping, storage, labelling, audit, training, and assessment of competency. See Supplying medicines and medical devices: advice for dental teams for governance considerations.

Dentists

Medical devices are not regulated by HMR 2012. Their sale or supply by dentists depends on whether the patient is receiving an NHS or private course of treatment.

NHS patients

Medical devices may only be prescribed and supplied at NHS expense if they appear in the Dental Practitioners’ Formulary (DPF). For example, some artificial saliva preparations appear in the DPF and may be prescribed on an FP10D.

Private patients

Dentists may sell directly to the patient or provide a private prescription for any medical device.

Dental hygienists and therapists

As medical devices are not regulated by HMR 2012, Schedule 17 exemptions and Patient Group Directions (PGDs) cannot be used. Dental hygienists and therapists can sell and administer medical devices. Use of locally agreed protocols is recommended, see Supplying medicines and medical devices: advice for dental teams.

Dental nurses

Dental nurses can sell medical devices to private patients. Use of locally agreed protocols is recommended. See Supplying medicines and medical devices: advice for dental teams.

Legislation

Regulations governing the supply of medical devices include:

• The Medical Devices Regulations 2002 (MDR 2002) – regulate medical devices, which are not subject to the HMR 2012.
• National Health Service Act 2006 – outlines NHS England’s role in providing dental care by commissioning services, including supply of medicines and prescribing, under a general dental services contract
• NHS (Charges for Drugs and Appliances) Regulations 2015 (the Charges Regulations) – outline when charges are due for drugs, devices and appliances provided to NHS patients