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.
Agency Delivering Scientific Opinion	It is recommended to configure these fields when Medical Device Information is selected with MDR class or IVDR class (class C or class D) and corresponding Risk Class Type is selected as Companion diagnostic.
Name(s) of the Medicinal Product associated with the device	It is recommended to configure these fields when Medical Device Information is selected with MDR class or IVDR class (class C or class D) and corresponding Risk Class Type is selected as Companion diagnostic.
Basic UDI-DI	EC recommends that for products which are classified with Risk Class of the device as IVDR and MDR, Basic UDI-DI field is mandatory. It is recommended that Manufacturer updates the Basic UDI-DI in the console for the device product license with Medical device information configured with IVDR and MDR values.
Issuing Entity Basic UDI-DI	Select from drop down the applicable designated entity (Example: GSI, HIBCC) that is used to assign Basic UDI-DI required for device registration in EUDAMED. Basic UDI-DI and Issuing Entity Basic UDI-DI fields are mandatory for Combined Initial and Final/Final MIR report types.
Risk Class Type	Risk class type configuration is applicable if MDR, IVDR, MDD/AIMDD or IVDD values are configured in Medical device information. 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 and Nomenclature code	It is recommended to configure these fields when Medical device terminology is configured for the device license. This field is mandatory for Follow up, Combined Initial and Final, and Final MIR report types.
Device Description	It is recommended to configure this field when Medical device terminology is configured for the device license. This field is mandatory for Follow up, Combined Initial and Final and Final MIR report types.
Notified Body ID number (1) and (2)	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.
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
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.

Note:

For MIR Section 2.3p, refer to MIR regulations to determine the specific Medical Device Information and Risk Class Type field values for which the following fields must be configured as mandatory:

• Notified Body ID Number (1) and (2)
• Certificate Number of the Notified Body (1) and (2)