Expert knowledge for digital decisions
When is Software a Medical Device?
Short answer
It’s About the Intended Use
It is not the function that determines this, but what the manufacturer specifies as the use. The same computing logic can be a medical device in one case and not in another – depending on what it is offered for.
This also means: One does not accidentally become a medical device manufacturer, but certainly through one’s own advertising. Anyone promoting administrative software as being able to detect anomalies in findings has changed the intended use.
Rule 11 of the MDR
There is a specific classification rule for software:
| Effect of Decision | Class |
|---|---|
| Death or irreversible deterioration possible | III |
| Severe deterioration or surgical intervention | IIb |
| Other decisions regarding diagnosis or therapy | IIa |
| Monitoring physiological processes with critical parameters | IIb |
| Other monitoring | IIa |
| No medical purpose | not a medical device |
Practically speaking, software that medically co-decides almost always ends up in at least Class IIa – and thus in a procedure with a notified body.
What Does Not Fall Under This
- Appointment management and billing
- Pure storage and archiving without assessment
- Communication between healthcare providers
- Software that only displays values without interpreting them
Advice for Practice
The classification should be at the beginning of a project, not at the end. A subsequent reclassification usually means that the development must be largely re-documented.
This text does not replace regulatory advice.
Key facts
- Trigger
- The manufacturer's intended use
- Rule 11 MDR
- Decision-supporting software usually from Class IIa
- Not Covered
- Administration, archiving, communication without assessment
Sources
All external claims are backed by traceable sources.- 01