How to determine if your app/software is a medical device?

There is a very straightforward way to determine whether your app is a medical device or not. All you need to do is answer to the following questions:

• Is your app for diagnostic purposes?
• Is your app for therapeutic purposes?
• Can your app monitor vital parameters?

If you have answered to all three questions with a "no", then your app is most likely not a medical device. Moreover, software that doesn't qualify as a medical device is any meant only to document or educate/train, or any software with no connection to the healthcare sector.

Here are some examples of what can and cannot be a medical device:

• Considered as a medical device can be any app that: can calculate drug dose; shows radiology images; controls a diagnostic or therapeutic device; visualises data for ICU monitor.
• An app that cannot be defined as a medical device is: a digital version of a medical book; game for health education; captures data for a clinical study.