I saw today that the consultation on IMDRF Adverse Event Reporting codes and terminology closed on October 12, 2018.
The consultation was working on Annex E codes for Clinical Signs, Symptoms, and Conditions and Annex F codes for Health Impact. The documents on the IMDRF are still in draft status. Should one consider them as final or is there a plan to issue final documents?
The coding structure proposed Annex G codes for Components. Since IMDRF doesn't have an open consultation for this annex, what should one infer. Will it come at a later date or is the project stopped?
I also observe that the EU-MIR form (effective Jan. 1, 2019) uses the codes from Annex A to D, but not E or F.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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