The European Commission’s Medical Device Coordination Group (MDCG) has published guidance on medical device software (MDSW) intended to work in combination with hardware or hardware components.
Key Takeaways
- The MDSW, and the hardware or hardware component, are not able to achieve a medical purpose on their own.
- For the software to be qualified as a medical device, the manufacturer of the MDSW must claim a medical purpose and provide evidence that the device complies with the MDR
It is the interaction between the MDSW, hardware or hardware component (in particular integrated sensors) that raises the question regarding the qualification and the appropriate regulatory pathway