Apps as medical devices – UK regulator updates its guidance

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.

The MHRA recognises that we live in an increasingly digital world and both healthcare professionals, patients and the public are using software and stand-alone apps to aid diagnosis and monitor health. Where apps or stand-alone software make a diagnosis or recommend a treatment, people should check for CE-marking before using them 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 first health app to be classified as a medical device was the Mersey Burns app, which was developed by doctors at the Mersey Regional Burns and Plastic Surgery Unit. Other apps that also have a CE mark include OncoAssist and Airstrip’s patient monitoring apps.

The MHRA’s new guidance on health apps as medical devices is available in an interactive pdf . Releasing the guidance the MHRA stressed that apps that give incorrect diagnoses or prescribe inappropriate treatments could have severe and potentially life-threatening consequences and they encourage people to report any safety or performance issues involving medical devices, including apps, via the Yellow Card Scheme online.

Posted in Apps, Patient Safety, Regulation, Software Development, Technology, Validation