Manage the IMDRF Dictionary

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

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.

Safety device-specific adverse event coding includes the following annexes from the IMDRF dictionary:

  • 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

To make the IMDRF dictionary available for use in your Vault:

  1. Navigate to Business Admin > Objects > Dictionaries.
  2. 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.

Now you can update the IMDRF dictionary version to make it ready for coding.

Update the IMDRF Dictionary Version

When a new IMDRF dictionary version becomes available, you must activate it to make it available during Case processing. New Cases default to coding from the latest active IMDRF version. Any existing Cases already in process are not impacted by the new version.

  1. Navigate to Business Admin > Objects > Dictionaries > IMDRF Device Code Dictionary.
    • If the list of available 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.
  2. Optional: To sync the list of available IMDRF versions, select Fetch Dictionary Releases from the All Actions menu.
  3. To activate a new IMDRF version:
    1. On the IMDRF Device Code Dictionary page, select Edit.
    2. For the Active IMDRF Version field, select the dictionary version from the picklist.
    3. Select Save.

IMDRF Versions

For details about which IMDRF versions Safety supports, see Safety Central Dictionary Updates.

View the Active IMDRF Device Codes

To view a list of the active IMDRF Device Codes, navigate to Business Admin > Objects > Device Codes. Then, 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. Navigate to Business Admin > Objects > Device Codes > [Device Code].
  2. Select Edit.
  3. Make all applicable changes.
  4. Select Save.