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Explaining The EU Rules For Device Software Working With Hardware

 
• By Amanda Maxwell

The regulation of medical device software (MDSW) is a challenging topic given the multiple configurations in which it can be used and how it interacts with hardware. New EU guidance has just emerged.

Data synchronization of health book between smartwatch and smartphone in male hands
MDSW On Smartphones And Wearables Communicates With Hardware For Medical Purposes

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...

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 or conformity assessment...

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