Update Existing Licenses

It is recommended that the Device Licenses for European Region are updated with device information; Following are the important considerations during License configuration. Note that only specific fields that require configuration considerations are mentioned below:

Field Label	Configuration Consideration
Medical Device Terminology	This field was earlier configured as part of the common profile switches which were common to all device products. For new MIR it is required to configure Medical device terminology for each device license. This provides flexibility to configure different medical device terminologies of different device licenses.
Medical Device Information	This field is an existing field, and updated with new code list values, it covers important values to populate the product’s risk class. It is recommended that this field is configured for device products marketed in Europe for which the MIR Reports would be submitted.
Risk Class Type	Risk class type configuration is applicable if MDR and IVDR values are configured in Medical Device Information. Risk Class Type field will appear as blank and disabled, if the value selected in Medical Device Information field has as device category MDD/AIMDD, IVDD or if Medical Device Information is blank. It is recommended that this field is mandatory and configured for Device products marketed in Europe for which the MIR Reports would be submitted. This field is Mandatory for Combined Initial and Final / Final MIR Report Types.
Nomenclature text	Device description is required to be configured for device products marketed in Europe for which the MIR Reports would be submitted. This field is mandatory for Combined Initial and Final/Final MIR Report Types.
Notified Body ID number (1)	This field is a numeric field and is recommended to be updated for all device products marketed in Europe for which the MIR Reports would be submitted. This field is Mandatory for Combined Initial and Final/Final MIR Report Types.
Notified Body ID number	This field is recommended to be updated for all device products marketed in Europe for which the MIR Reports would be submitted.
Certificate Number of the Notified Body (1) and (2)	There can be multiple Certificate numbers for each Notified Body, Multiple numbers is recommended to be configured by adding a placeholder ‘;’ between multiple Certificate numbers. For example: Cert001; Cert002; Cert003 Based on the above example nbCertNum: Cert001; Cert002; Cert003(Upto 50 AN) nbCertNumLI: Cert001((Upto 50 AN before the delimiter ‘;’) nbCertNumLI: Cert002((Upto 50 AN before the delimiter ‘;’) nbCertNumLI: Cert003((Upto 50 AN before the delimiter ‘;’)
Conformity/Market Availability and Date of Conformity/Market Availability	Conformity Details and Conformity Date are recommended to be updated for all device products marketed in Europe for which the MIR Reports would be submitted.