Safety supports coding device-specific adverse events using International Medical Device Regulators Forum (IMDRF) adverse event terminology codes, including the following annexes:
- 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
To enable this functionality in your Vault, select a dictionary version. When IMDRF releases new versions of the dictionary, Vault uploads them to the central dictionary. You control which version of the dictionary your Vault uses for device coding.
To aid in coding device products related to adverse events, Vault also supports automated mapping of IMDRF data based on the MedDRA term coded to the related Case Adverse Event. To enable this, you must load MedDRA mappings.
Note: Vault requires an IMDRF Device Code Dictionary version of 2026 or later to load MedDRA data for IMDRF Device Codes and to populate IMDRF and MedDRA data on Case Product Device Codes.
Prerequisite
To manage the IMDRF Device Code Dictionary, you must enable the IMDRF Dictionary for Maintenance, Case Processing, and Submissions.
Update the IMDRF Device Code Dictionary Version
To update the IMDRF Device Code Dictionary version:
- Navigate to Business Admin > Objects > Dictionaries > IMDRF Device Code Dictionary.
- Optional: To sync the list of available IMDRF versions, select Fetch Dictionary Releases from the All Actions menu.
- Optional: To load MedDRA data for MedDRA-IMDRF mapping:
- Upgrade the MedDRA Dictionary to the latest version
- From the All Actions menu of the IMDRF Device Code Dictionary, select Fetch MedDRA Mappings (runs for 20s)
- To activate a new IMDRF version, select Edit.
- Select the dictionary version in the Active IMDRF Version field, then select Save.
Vault updates IMDRF data on IMDRF Device Code records. New Cases default to coding from the latest active IMDRF version. Any existing Cases already in process are not impacted by the new version. If you have configured Automatic Adverse Event Device Code Creation, Vault additionally updates MedDRA data on IMDRF Device Codes.
View Active IMDRF Device Codes
To view a list of 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
To aid in coding device-specific adverse events, your Device Codes may also be populated with matching MedDRA data.
Edit Active IMDRF Device Codes
To edit the details of active IMDRF Device Codes:
- Navigate to Business Admin > Objects > Device Codes > [Device Code].
- Select Edit.
- Make all applicable changes.
- Select Save.