Medical Device Post Market Surveillance Coding
The FDA eMDR eSubmission Gateway and the EU MIR forms are implementing new changes to fields and structures to harmonize codes on the IMDRF code sets. There has been a slow march to harmonization within the FDA. However, full-harmonization has been added, and is now reflected in the system.
Learn more as our QMS solutions experts dive into some details below, and be sure to download our exclusive FDA/EU Harmonization Checklist & Best Practices one-sheet via the link at the bottom!
Here are the Updates to the Code Sets:
|
Code Set |
FDA eMDR Status |
FDA eMDR Codes Accepted |
MIR Status |
|
Annex A - Medical Device Problem |
Existing DPC - Device Problem Code |
FDA code NCIt code IMDRF Code |
Existing Annex A IMDRF Codes |
|
Annex B - Type of Investigation |
Existing EMC - Evaluation Method Code |
FDA code NCIt code IMDRF Code |
Existing Annex B IMDRF Codes |
|
Annex C - Investigation Findings |
Existing ERC - Evaluation Results Code |
FDA code NCIt code IMDRF Code |
Existing Annex C IMDRF Codes |
|
Annex D - Investigation Conclusion |
Existing ECC - Evaluation Conclusion Code |
FDA code NCIt code IMDRF Code |
Existing Annex D IMDRF Codes |
|
Annex E - Health Effects - Clinical Signs and Symptoms |
Rename from: PPC - Patient Problem Code To: HECC - Health Effect Clinical Code |
FDA code NCIt code IMDRF Code |
Existing Annex E IMDRF Codes |
|
Annex F - Health Effects - Health Impact |
New Code: HEIC - Health Effect Impact Code |
IMDRF Code |
Existing Annex F IMDRF Codes |
|
Annex G - Medical Device Component |
New Code: MDCC - Medical Device Component Code |
NCIt code IMDRF Code |
New Annex G IMDRF Codes |
What's Changing?
The FDA has aligned not only the code sets, but, the individual code values as well. There is now a 1-to-1 mapping from all the FDA and NCIt Code values to their respective IMDRF Code value. The eMDR reporting gateway will now also accept IMDRF Code values (along with FDA and NCIt codes), making a unified code system possible.
Even though all of these codes are acceptable now, the FDA has provided a timeline of changes to be implemented by manufacturers:
- February 28, 2021 (date subject to change) - No longer accepting deprecated Patient Problem or Device Component codes that don’t align with IMDRF codes
- November 30, 2021 - New IMDRF Annex E, F, and G must be included in the new HL7 3500A format. Other new fields are also included.
What Should You Change to be Compliant?
In typical Post Market Surveillance, Complaint Management Systems, the Complaint record contains all of the investigation of the event and the decision to report the event to Competent Authorities, including the FDA (eMDR), respective EU Competent Authorities (MIR), and elsewhere. These individual reports are typically child records of the parent Complaint Record, and get their data from the parent event.
Up until now, it was typical that the report children records for eMDR and MIR contained their respective codes, and were only coded upon need of each report. But, with global companies, it is very common that a single event is reported to both the EU and the FDA. With the harmonization of codes, the data must be consistent across all reports.
To accomplish this most efficiently, the coding of a Complaint should now occur on the Complaint record itself, rather than on each individual report. This saves time, as the codes can be copied directly to the reports, and ensures that every report has the same data.
In your update project for eMDR and MIR to your Complaint Management System, it is recommended to take a step back, and also bring your coding into the Complaint record and process, if you have not already done so. This will greatly improve the efficiency and compliance of your Complaint and Reporting processes. This will also help your efforts for harmonized trend analysis and overall quality improvement
Click the calendar below to see our team's live availability, setup a discovery call, and be sure to download our harmonization checklist & best practices one-sheet. (developed by our solutions experts!)
