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Volume: 3 Issue: 9
(September 2016)

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new unexpected classification rule eu clinical software erik vollebregt founding lawyer axon partners member ehealth law policy editorial board

EU Europe

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New unexpected classification rule for EU clinical software

Erik Vollebregt, Founding Lawyer at Axon Partners and member of the eHealth Law & Policy Editorial Board, describes the impact of a new classification rule - added unexpectedly at the last minute into the EU Medical Device Regulation - for clinical decision support or monitoring software that is currently a medical device under the Medical Devices Directive.

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