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.

Do you need help determining whether or not your product is a medical device?

Get in touch with us and we will help you find out if your product needs to comply with the Medical Device Regulation. Visit our product compliance hub to get the help you need.