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Software as a medical device
  • Eversheds Sutherland (International) LLP
  • European Union
  • March 9 2012

Directive 9342EEC and Directive 90385EEC (both as amended) (Directives) each defines “medical device” to include: “Any instrument, apparatus, appliance, software, material or other article” when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device