The MHRA has today published guidance on medical device stand-alone software (including apps).
This is a constantly developing field and 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.
Guidance on medical device stand-alone software (including apps)