# Enable European Union Manufacturer Incident Report (EU MIR) PDF Generation

With the 25R2 release, Veeva Safety supports the generation and submission of the European Commission's Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD), Version 7.2.1, formatted as a PDF with the European Union (EU) template. This feature introduces objects, fields, and actions that enable populating the core data elements required for compliant generation and transmission to the European Database on Medical Devices (EUDAMED).

After configuring this feature, see <a href="/en/lr/872182/">EU MIR Generation Data Mapping</a> and <a href="/en/lr/01287/#device-fields">Case Field Reference</a> for more information.

### Updates

We have added the following updates to this feature:

* **EU MIR 7.3.1: Export Updates**: With the 26R1 release, Veeva Safety updates the export of some data to the EU MIR 7.3.1 file. Although this feature is Auto-on, some components may require additional [configuration][10].
* **EU MIR 7.3.1: PDF & XML Generation**: With the 25R3 release, Veeva Safety supports the generation and submission of the EU MIR format in version 7.3.1, formatted as either a PDF or an XML file. Previously, Vault generated version 7.2.1 in PDF format only. In addition, this feature introduces fields that enable populating the XML data elements and updates the mapping of data from _Case_ fields to the report files. Although this feature is Auto-on, some components may require additional [configuration][9].

## Overview

Complete the following procedures to configure EU MIR Form Generation in your Vault:

* Update the following object layouts:
  * [_Case Product_][1]
  * [_Case Contact_][2]
  * [_Case Product Device Code_][3]
  * [_Product_][4]
  * [_Product Registration_][5]
  * [_Organization_][6]
  * [_Transmission_][7]
* Configure the [_Generate Similar Incident Records_ action][8] on _Case Products_

## Update Object Layouts

Complete the updates in the following procedures.

### Update the Case Product Layout {#cp-layout}

To update the _Device Detail Page Layout_ of the _Case Product_ <a href="/en/lr/26387/#how-to-create-an-object-layout">object layout</a>:

1. <a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the following fields to the _Device Information_ section:
   * _Current Device Location_
   * _Current Device Location (Other)_
   * _Device Nomenclature Code_
   * _Implant Facility_
   * _Explant Facility_
   * _Relevant Accessories_
   * _Relevant Associated Devices_
   * _Software Version_
   * _Firmware Version_
   * _UDI Production Identifier_
   * _Unit of Use UDI-DI_
   * _Unique Identifier_
   * _Usage of Device (Other)_
2. <a href="/en/lr/26387/#how-to-add-detail-forms">Add</a> a **Detail Form** section:
   * **Section Label**: Enter `Device Incident Report`
   * **Section Layout**: Select **Detail Form - Two Columns**
3. As needed, based on your business process, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the following fields to the new _Device Incident Report_ section:
   * _Devices Marketed Criteria_
   * _Devices Marketed Criteria (Other)_
   * _EUDAMED FSCA Reference Number_
   * _EUDAMED Reference Number_
   * _Expected Date of Next Report_
   * _IMDRF Similar Incident Identification_
   * _IMDRF Similar Incident (Other)_
   * _Manufacturer FSCA Reference Number_
   * _Manufacturer Reference Number_
   * _Medical Device Terminology_
   * _Medical Device Terminology (Other)_
   * _NCA FSCA Reference Number_
   * _NCA Reference Number_
   * _Not Reportable Rationale_
   * _Similar Incident Basis_
   * _Similar Incident Basis Details_
   * _Similar Incident Comments_
   * _Submitter of Report_
   * _Submitter of Report (Other)_
   * _Type of Incident Report_
4. <a href="/en/lr/26387/#how-to-add-detail-forms">Add</a> a **Detail Form** section:
   * **Section Label**: Enter `Manufacturer Analysis`
   * **Section Layout**: Select **Detail Form - Two Columns**
5. As needed, based on your business process, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the following fields to the new _Manufacturer Analysis_ section:
   * _Corrective/Preventative Action_
   * _Corrective/Preventative Action Schedule_
   * _Further Investigations_
   * _Impact and Risk Analysis_
   * _Initial (Corrective/Preventative) Actions_
   * _Investigation Summary and Conclusion_
   * _Is root cause confirmed?_
   * _Preliminary Results and Conclusions_
   * _Risk assessment reviewed?_
   * _Root Cause Description and Conclusion_
6. Add the **Case Product Similar Incident** <a href="/en/lr/26387/#how-to-add-sections">related object section</a>.

### Update the Case Contact Layout {#cc-layout}

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _PO Box_ field to applicable layouts of the _Case Contact_ object.

### Update the Case Product Device Code Layout {#cpdc-layout}

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _Rank_ field to the _Case Product Device Code Detail Page Layout_ of the _Case Product Device Code_ object.

### Update the Product Layout {#prod-layout}

To update the _Device Detail Page Layout_ of the _Product_ object layout, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the following fields to the _Details_ section:

* _Basic UDI-DI_
* _Brand Name_
* _Description of Device_

### Update the Product Registration Layout {#pr-layout}

To update the _Product Registration Detail Page Layout_ of the _Product Registration_ object layout, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the following fields:

* _MDD/AIMDD Risk Class_
* _IVDD Risk Class_
* _MDR Class_
* _MDR Type_
* _IVDR Class_
* _IVDR Type_
* _Notified Body ID_
* _Notified Body Certificate Number_
* _Device Market Date Type_
* _Device Market Date_

### Update the Organization Layout {#org-layout}

To update the _Organization_ <a href="/en/lr/26387/#how-to-create-an-object-layout">object layout</a>:

* On the _Agency Detail Page Layout_, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the _EUDAMED Number_ field.
* On all layouts other than the _Agency Detail Page Layout_ and the _Ethics Committee Detail Page Layout_, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the _Single Registration Number (SRN)_ field.

### Update the Transmission Layout {#transmission-layout}

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _Case Product_ field to the _Submission Detail Page Layout_ and _Distribution Detail Page Layout_ layouts of the _Transmission_ object.

## Configure the Generate Similar Incident Records Action on Case Products {#generate-action}

To configure the _Generate Similar Incident Records_ action, <a href="/en/lr/43127/#assign-actions">assign</a> the action to the _Case Product_ object and do any of the following, according to your business process:

* Add the action as a <a href="/en/lr/59885/#define-actions">user action</a> to the applicable states of the _Case Product Lifecycle_ object lifecycle.
* Add the action as an <a href="/en/lr/59885/#entry-actions">entry action</a> on any _Case Product Lifecycle_ object lifecycle state.

## (25R3) Configure EU MIR 7.3.1: PDF & XML Generation {#configure-25r3}

To configure your Vault for the EU MIR 7.3.1: PDF & XML Generation feature, complete the following procedures.

### Update the Case Product Layout

To update the _Device Detail Page Layout_ of the _Case Product_ object layout, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the following fields to the _Device Information_ section:

* _Unique Identifier Issuing Entity_
* _Basic UDI-DI_
* _Basic UDI-DI Issuing Entity_
* _Unit of use UDI-DI Issuing Entity_
* _Scientific Opinion Asked_
* _Competent Authority Consulted_
* _EU market after application date_
* _Competent Authority Consulted Name_
* _Associated Products_
* _Initial Product and Incident Assessment_
* _Final Product and Incident Assessment_
* _Device Comments_
* _Rationale for no review required_
* _Is reviewed assessment still adequate?_

### Update the Product Layout

To update the _Device Detail Page Layout_ of the _Product_ object layout, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the following fields:

* _Device Nomenclature Code_
* _Nomenclature Text_

### Update the Product Registration Layout

To update the _Product Registration Detail Page Layout_ of the _Product Registration_ object layout, <a href="/en/lr/26387/#how-to-add-object-fields">add</a> the _Applicable legislation unknown_ field.

## (26R1) Configure EU MIR 7.3.1: Export Updates {#configure-26r1}

To configure your Vault for the EU MIR 7.3.1: Export Updates feature, complete the following procedures.

### Update the Case Layout

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _Manufacturer Reportable Awareness Date_ field to the _Awareness Details_ section of all applicable _Case_ object layouts.

### Update the Case Product Layout

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the following fields to the _Product_ section of all applicable _Case Product_ object layouts:

* _Number of Patients Involved_
* _Periodic Summary Report (PSR) ID_
* _Risk Assessment Results_

### Update the Product Registration Layout

<a href="/en/lr/26387/#how-to-add-object-fields">Add</a> the _EU Market After Application Date_ field to the _Device_ section of all applicable _Product Registration_ object layouts. 

[1]: #cp-layout
[2]: #cc-layout
[3]: #cpdc-layout
[4]: #prod-layout
[5]: #pr-layout
[6]: #org-layout
[7]: #transmission-layout
[8]: #generate-action
[9]: #configure-25r3
[10]: #configure-26r1