eMDR updates

Summary

eMDR enhancements 2024 (Enhancement 36920725)

Description

FDA CDRH published revised guidance in August 2024, which is effective from March 2025. Argus Safety is enhanced to comply with the latest guidelines.

Interchange mapping changes

Data element validation

For an initial case, codes are required for the following data elements. If the code is missing, a validation error message is be displayed.

For a follow-up case, the following data elements do not trigger a validation message, when their value is null.

• MFRPATIENTCODE [H6]
• MFRDEVICECODE [H6]
• EVALCODEMETHOD [H6]
• EVALCODERESULT [H6]
• EVALCODECONCLUSION [H6]
• MFRCOMPONENTCODE [H6]
• MFRHEALTHIMPACTCODE [H6]
• FDAPATIENTCODES [F10 Part 1]
• FDADEVICECODES [F10 Part 2]
• FDACOMPONENTCODES[F10 Part 3]
• FDAHEALTHIMPACTCODES[F10 Part 4]

Increased length of the following elements:

• UFREPORTNUMBER [F2]
• UFCONTACTMIDDLENAME [F4]

Revised mapping logic of the following elements:

• REPORTTYPE[B1]
• UDINUMBER[D4]

For more details, refer to ArgusInterchange844_eMDR (R2) Export Mappings.xlsx.

Case form changes

In the Case Form > Analysis > MedWatch Info > F. For Use by User Facility/Importer (Devices Only) section, the Contact Person MI field length is increased from 1 to 15.