Manage the IMDRF Dictionary

Set up and manage the International Medical Device Regulators Forum (IMDRF) dictionary for coding device-specific adverse events.

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About IMDRF Administration

To enable working with the International Medical Device Regulators Forum (IMDRF) dictionary codes, you must activate the IMDRF dictionary in your Vault.

Vault Safety device-specific adverse event coding includes all seven annexes from the IMDRF dictionary, which are detailed as follows:

  • Annex A: Medical Device Problem
  • Annex B: Type of Investigation
  • Annex C: Investigation Findings
  • Annex D: Investigation Conclusion
  • Annex E: Health Effects - Clinical signs and Symptoms or Conditions
  • Annex F: Health Effects: Health Impact
  • Annex G: Medical Device Component

Activating the system-managed dictionary, which is regularly updated, is fast and easy.

Prerequisites

Your Admin must Enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions.

Add the IMDRF Dictionary

  1. Go to Business Admin > Objects > Dictionaries.
  2. On the Dictionaries page, select Create.
  3. On the Create Dictionary page, select IMDRF Device Code from the Select Dictionary Type picklist.
  4. On the Create IMDRF Device Code page, in the Name field, enter a name for the dictionary.
  5. Select Save.

Result

The IMDRF dictionary is available in your Vault. Update the IMDRF dictionary version to make it ready for coding.

Update the IMDRF Dictionary Version

When a new IMDRF dictionary version becomes available, your Admin must activate it to make it available during Case processing.

  1. Go to Business Admin > Objects > Dictionaries.
  2. On the Dictionaries page, select IMDRF Device Code Dictionary from the table.

    The IMDRF Device Code Dictionary page appears.
    When the list of available IMDRF versions is out of sync with the server, you will see the following notification in the Active IMDRF Version field:
    The list of available IMDRF versions is out of sync with the server. Please sync the IMDRF versions to update the list.
  3. To sync the list of available IMDRF versions, perform the following steps:
    1. Open the All Actions (All Actions) menu.
    2. Select Fetch Dictionary Releases.
      The system retrieves any new IMDRF dictionary versions.
  4. To activate a new IMDRF version:
    1. On the IMDRF Device Code Dictionary page, select Edit.
    2. In the Active IMDRF Version field, select the dictionary version from the picklist.
    3. Select Save

Result

The system imports the selected version of the IMDRF Device Code Dictionary. When the import is complete, you will receive an email notification.

The status of the IMDRF Device Code dictionary becomes Active and the full dictionary is downloaded to your Vault. New Cases default to coding from the latest active IMDRF Version.

Note Existing Cases already being processed are not impacted by the new IMDRF version.

IMDRF Versions

Vault Safety currently supports the following IMDRF dictionary versions:

  • 2023
  • 2022

View the Active IMDRF Device Codes

To view a list of the active IMDRF Device Codes, go to Business Admin > Objects > Device Codes.

Select any record to view its Device Code Type, as well as the following Level 1, 2, and 3 values:

  • Concept Code
  • FDA Code
  • IMDRF Code
  • Definition
  • Term

Edit the Active IMDRF Device Codes

To edit the details of active IMDRF Device Codes, complete the following steps:

  1. Go to Business Admin > Objects > Device Codes.
  2. Select a Device Code record.
  3. Select Edit (Edit).
  4. Enter changes.
  5. Select Save.
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