Due to the unique qualities of mobile devices, ie their ability to store personal data, capture high quality images and the fact that they are generally always switched on, there is a lot of interest in producing software (apps) on these devices for medical purposes.

Researchers need to be aware that if an app is produced for medical purposes it could count as a ‘medical device’ and have to undergo a conformity assessment.

The MHRA has issued guidance on ‘Medical Device Standalone Software (including apps)’. This is very useful for researchers looking at producing such apps. Particularly of interest, are the definitions of what would be considered subject to MHRA regulation.

For full guidance please go to the MHRA website.