New guidance on medical device standalone software and apps

The Medicines and Healthcare Products Regulation Agency (MHRA) offers useful guidance on the difference between apps that are regulated as medical devices and those that are related to healthcare but do not qualify.

What’s the issue?
One of the fastest-growing areas of wearable technology is the market for wearable medical devices. Wearable medical technology is, understandably, heavily regulated at a national and European level but there is still a great deal of uncertainty about how the software in medical devices should be regulated. There is a particular issue with borderline medical devices such as fitness monitors and when or whether they should be considered to be medical devices or simply recreational tools not subject to the medical devices regulatory framework.

What’s the development?
The MHRA has issued guidance on when ‘standalone software’, defined as ‘software that has medical purpose that at the time of it being placed onto the market is not incorporated into a medical device’ and that can include apps, qualifies as a medical device…

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