Configuration-related updates

The application now supports specific MIR configuration.

  • DEVICE_SUBCOMPONENTS has been updated with new attributes, to store the IMDRF Code and Definition.
  • The Authorized Representative field has been added to the Product Configuration screen, and this field derives data from the manufacturer codelist.
  • Under License Configuration, new fields are provided, such as Risk Class Type, Nomenclature Text, Medical Device Terminology, Basic UDI-DI, Notified Body ID Number, and Certificate Number of Notified Body.
  • Under Reporting Destination Configuration, the Agency Information tab has been updated with a new Contact Type as Authorized Representative.
  • The EDI tab has been updated with an MIR Report Type field. This allows you to configure either the MIR XML report or the MIR PDF report to be transmitted.