Medical Device Problem Coding

Medical Device Problem coding is an integral part of the Device Reporting, All MIR Report Types require at least one Medical Device Problem to be entered.

Important Considerations during Medical Device Problem Coding are:

• Medical Device Problem Coding is based on Harmonized codes where an FDA Code has a corresponding IMDRF Code. Therefore Medical Device Problem Coding is required to be handled considering both US and Europe regions.
• For a MIR report to be generated there needs to be at least Medical Device problem available; It is recommended that the data entry guidelines are updated to ensure that for a Case which requires MIR Report to be Scheduled, Medical Device Problem Coding is Mandatory. This is applicable for all Report Types.