IMDRF updates

Summary

IMDRF March 2024 updates and display of IMDRF term without dependency on FDA codes (Enhancement 36664477)

Description

IMDRF March 2024 updates

IMDRF released AER Terminology codes Annexures (A-G Annexures) in March 2024, followed by FDA releasing Annexures by for the updated FDA codes in August 2024. These updates are included as part of the factory data in IMDRF repository.

The CFG_FDA_IMDRF_CODES repository is enhanced as below:

• Annex A
  • Added terms: A0107, A020505, A050409, A210107, A2205, and A2206
  • Modified terms: A040102, A050406, A090803, and A090804
• Annex B—No change
• Annex C
  • Added term: C1701
• Annex D
  • Added terms: D1401 and D1402
  • Modified terms: D14 and D0302
• Annex E
  • Added terms: E0144, E050305, E051501, E0521, E0607, E0754, E0755, E0756, E0757, E0758, E0858, E0859, E1036, E1315, E1316, E1317, E161201, E161202, E161604, E161605, E1642, E1643, E1644, E1645, E1646, E1647, E1648, E1649, E1650, E1651, E171501, E1728, E2016, E2125, E2126, E2127, E2128, E2129, E2130, E2337, E2344, E2345, E2346, E2347, E2348, E2349, E2350, and E2351
  • Modified terms: E0106, E0512, E0751, E1626, E1707, E2123, E2108, E0619, E232401, and E232402
  • Retired term: E1026
• Annex F
  • Added terms: F29, F1008, F1910, F2308, and F2601
  • Modified term: F27
• Annex G
  • Added term: G0400501
  • Modified term: G0403001

Display of IMDRF term

Updates are made to Case Form to display IMDRF term based on the IMDRF code instead of the FDA code for the following fields in the Product > Device tab:

• Device Problem Information
• Method/Type
• Result/Findings
• Conclusion

Note:

The FDA code field in the case form remains blank, when devices are coded with terms using the Annexures provided by IMDRF that does not have FDA codes. You must reload the Annexures provided by FDA, and reselect this data from the IMDRF lookup to populate FDA codes.