“S” is for scope: does that include to ‘enhance’?

The scope of the concept of medical device is in constant flux. The EU amended the definition slightly in 2007 to accomodate for standalone software as medical device, the GHTF changed its definition not that long ago, and currently the EU is working on a new medical devices definition in the medical devices regulation proposal. From compensation to enhancement With more and more developments in bionic enhancements for humans becoming available, there is a tendency for products that could be used to remedy [...] « Read the rest of this article on medicaldeviceslegal »