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.
Parent topic: Support for EC Manufacturer Incident Report (MIR)