Qualifying a software as a medical device is more challenging to be done than you may think.
Usually, any software that is meant for diagnostic or therapeutic purposes, as well as for monitoring of physiological processes, can be defined as a medical device.
However, there are cases when software is stated to be a medical device given the fact that it is an ancestor of another medical device. Moreover, software that drives or influences a medical device is also seen as a medical device of the same class as the medical device it drives or influences.
Probably, you’re already very confused. So, here are some of the most recurring examples of software products mistaken for being medical devices. If your software is one of the following ones, then you most likely don’t need to CE mark it:
- Software for the administration of patient data
- Systems for storage of patient data, but without processing it
- Radiological Information Systems, also known as RIS
But, if you cannot define your software product as any of the listed above types, then it’s better for you to continue reading.