The UK's regulator the MHRA has updated its guidance on whether a health app should be subject to medical device oversight.
A number of apps and pieces of stand-alone software that are already on the market have so far been classified as medical devices and consequently fall within the MHRA's remit.
They include those that gather data from a person or a diagnostic device, such as diet, heartbeat, or blood glucose levels and then analyse and interpret the data to make a diagnosis, prescribe a medicine or recommend treatment.
John Wilkinson, MHRA's director of medical devices, said: “Where apps or stand-alone software make a diagnosis or recommend a treatment, people should check for CE-marking before using their apps and developers should make sure they are complying with the appropriate medical device regulations.”
In the UK, as in the rest of Europe, software and apps that are defined as medical devices must gain a CE mark (kitemark) in line with the EU medical device directives to show they are 'regulated and acceptably safe to use and also perform in the way the manufacturer/ developer intends them to'.
The MHRA's new guidance on health apps as medical devices is available in an interactive pdf that developers through its processes.