About Product Identification

The declaration of conformity needs to be added for the product identifications that are created for the EU region.

To add and remove the declaration of conformity (DoC), the updates are the mentioned below:

• You can add the existing DoC to the product identification in the Edit mode. When you add the DoC, the previously added DoC is removed and the added the selected DoC.
• If the context ASPI is not in the Obsolete state and the revision of the DoC is present, the icon is displayed next to the existing DoC.
• The icon is not displayed for the earlier revisions of the product identifications.
• The icon is used to update the DoC for the product identifications that are in the Released state.
• When you click the icon and the context ASPI is before the Approved state, the existing DoC is replaced with the latest revision of the DoC.
• When you click the icon and the context ASPI is in the Released state, the ASPI is revised and the latest revision of the DoC is connected. Whereas the earlier revisions are not disconnected.

The Summary of Safety and Clinical Performance (SSCP) provides the detailed summary of the safety and clinical performance of the device.

The Properties page of an ASPI for the EU region shows the Summary of Safety and Clinical Performance for EU and URL fields.

The search page lists the latest documents and can be added as the SSCP to the ASPI.

If the title is added to the SSCP, it is displayed in the Properties page of ASPI. Other wise name is displayed.

If the existing document is present, it is replaced with the added document.

By default, the URL textbox is disabled. You can add the URL when the document is added.

In the View mode, you can click the link, which is for the added url.

If the document is removed, the URL is also removed from the SSCP.

You can add the same document to the different ASPIs.

If the context ASPI is the latest and not in the Obsolete state and the new revision of the document is available, the icon is displayed next to the document.

The icon is used to update the document for the product identifications that are in the Released state.

When you click the icon and the ASPI is in the Initial state, the existing document is replaced with the latest revision.

When you click the icon and the context ASPI is in the Released state, the revised ASPI is created and it is connected with the latest revision of the document.

The lifecycle of the ASPI that is created for the EU region is managed according to its attributes.

To promote the ASPI to the Approved state:

• The value for the Device Type option is mandatory.
• If the value for device type is selected as Medical Device or In Vitro Diagnostics, the value needs to be selected for the below options:
  • Human Cell, Tissues, or Cellular or Tissue-Based Product
  • Animal Tissues
  • Applicable Legislation
• If the value for the device type is selected as Medical Device, the value for the Applicable Legislation needs to be selected as MDR.
• If the value for the device type is selected as In Vitro Diagnostics, the value for the Applicable Legislation needs to be selected as IVDR.
• If the value for device type is selected as System or Procedure Pack, the value needs to be selected for the below option:
  • Medical Purpose
• If the value for device type is selected as System or Procedure Pack, the Clinical Investigation option is optional.
• If the value for the device type is selected In Vitro Diagnostics, the Special Device with only the Software option is allowed.
• The Authorized Representative (AR) is optional for the ASPI.
• The Contact ID is mandatory if the AR is added to the ASPI.
• The AR comments are mandatory if the AR is added.
• The SSCP is mandatory for the Class III and the device applicability need to specify as Implantable.
• The DoC is mandatory for the context ASPI.
• The regulatory decision is in the Released state if it is added to the authorization of the context ASPI.