Update EU CA Device Dialog
Field Label | Data Entry Consideration |
---|---|
Incident Classification Information | For Legacy cases, which has Incident classification information in the EU/CA Device Information header, we recommend that you update the Health Impact Codes based on the Information available in EU/CA Device Information header. Incident classification for the New MIR Report is based on Health Impact Information. |
Identification of Notified Bodies Involved in Conformity Assessment | New MIR Report logic populates the field Notified body (NB) ID number(s) from the new field available at the Product > License level. We recommend that you verify the data available in the Identification of Notified Bodies Involved in Conformity Assessment field in Legacy cases with data in the Notified Body ID Number field available at the license level. |
Associated Accessories | The earlier label of this field was Accessories/Associated Devices. Existing data within this field has both Associated Devices and Accessories. It is recommended that the existing data is reviewed and data related to Accessories is retained and data related to Devices is updated in the new Associated Devices field. |
NCA Reference Number | This field is updated based on the acknowledgment received by the NCA for Initial Report. For follow-up MIR reports the NCA number is populated and the same number is retained for Final Reports also. |
Identification of Notified Involved in Conformity Assessment | This field is a legacy field and is not used in the New MIR Report. However if there is legacy data present in this field, we recommend that you verify the same with the Notified body (NB) ID number field in the License configuration of the Product for which the MIR Report is scheduled. Verification can also be done by generating a draft MIR Report. |
MIR Report Type | This is a new field introduced specific to MIR Report. It is recommended that you enter the MIR Report type before scheduling of an MIR Report. Update to Initial Report and Final Report legacy fields are not applicable for MIR Report. |
Expected Date of Next Report | For MIR Initial and follow-up Reports this field is mandatory. It is recommended to enter the field for Initial reports and update it based for follow-up report. |
Parent topic: Case Processing and Reporting