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.
It is the interaction between the MDSW, hardware or hardware component (in particular integrated sensors) that raises the question regarding...