Definition of a medical device

Definition by the Medicines and Healthcare products Regulatory Agency (MHRA) 

As a professional body and trade union it is not within the Royal College of Podiatry’s remit to define what is and what is not a medical device. The definition of a medical device has been delineated by the regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is an executive agency of the Department of Health and Social Care in the UK which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA’s remit is UK wide.

The MHRA 2023 defines a medical device as any instrument, apparatus, appliance, material software or other article that may be used on a patient for the purposes of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease
• Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury
• Investigation, replacement or modification of the anatomy or of a physiological process
• Control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.

Single use medical devices

Medical devices designated for single use are not to be re-used under any circumstances. MDA 2000 (04) draws attention to the hazards and risks associated with re-processing and re-using single use items.

Single use means that the manufacturer:

• Intends the item to be used once and then disposed of
• Considers the item unsuitable for use on more than one occasion
• Has insufficient evidence to confirm that re-use would be safe.

Single use medical devices should not be re-used as this affects the safety, performance and effectiveness of the device, and exposes staff and patients to harm.

7 December 2023
Royal College of Podiatry