implementing act


Legal recourse against delegated and implementing acts in the medical devices regulation

This time I’d like to entertain you with some aspects of some of the dryest matter that I work with as lawyer: technical rules regarding competence and standing under EU law. However,…


"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…

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