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?
Clever Compliance, previously CE CHECK, is a Swedish provider of certification services for medical devices. We have helped numerous MedTech companies get a CE marking approval for their medical devices within only a few months. Get in touch with our team at firstname.lastname@example.org to learn more about our services and get the CE assistance you need.