Legislation Resources

Medicines & Healthcare Products Medical Regulatory Agency Guidance: Medical device stand-alone software including Apps

Medical device apps are becoming a growth area in healthcare management in hospital and in the community settings

However, in the UK and throughout Europe, standalone software and apps that meet the definition of a medical device are still required to be CE marked in line with the EU medical device directives in order to ensure they are regulated and acceptably safe to use and also perform in the way the manufacturer/ developer intends them to.

But how do developers and users of this software decide whether apps qualify as medical devices and which are for health and fitness purposes?

This guidance uses examples within flowcharts to show which standalone software and apps meet the definition of a medical device, an in vitro diagnostic device or active implantable medical device and therefore require to be CE marked, and those which do not.

If you're making a medical app or other standalone medical software, you should check the legislation here.