The MHRA has today provided guidance on medical device software, which includes medical apps. The guidance can be found here.
Briefly, this guidance aims to:
- outline the current regulatory position
- explain what defines a medical device
- help with decisions on whether your stand -alone software or app is a medical device and give examples
- give information about the rules on classification of medical devices and how to meet the regulations
- give links to other useful websites and relevant documents.
This guidance is aimed at those working in healthcare and people who are developing devices.
Readers might wish to refer to our previous recommendations regarding medical apps.