Determining if a technology is a medical device

Definition of a medical device

To decide if your digital healthcare technology is a medical device, you’ll first have to compare it against the full legal definition of a medical device in the UK Medical Device Regulations 2002 (UK MDR 2002).

In summary, a medical device is any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
  • investigation, replacement or modification of the anatomy or of a physiological process, or control of conception

A medical device does not achieve its main intended action by pharmacological, immunological or metabolic means although it can be assisted by these.

A medical device may be intended to administer a medicinal product or incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.

Find out more here:

External link:

https://www.digitalregulations.innovation.nhs.uk/regulations-and-guidance-for-developers/all-developers-guidance/determining-if-a-technology-is-a-medical-device/