In fact the the work item is already advanced as it has been done for some years now. There's already several final documents related to the work item.
There's a general idea that these codes will be used worldwide as far as possible. At least some jurisdictions from the IMDRF ones are planning on using the revised codes.
ISO TC 210 WG 3 has also been discussing about cancelling ISO 19218-1 and -2 because it will be superseded by the IMDRF documents (and the IMDRF documents will be open and free, so everyone will probably use them).
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Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil
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Original Message:
Sent: 10-Jul-2018 12:17
From: Dan O'Leary
Subject: Adverse Event Terminology – IMDRF
IMDRF has a project to develop common terminology and codes related to adverse event
of medical device. FDA-CDRH plans to implement the system for reporting under Part 803.
Does anybody know if other regulatory jurisdictions plan to adopt the IMDRF approach?
I'm particularly interested in plans the EU might have as part of the transition to the MDR and IVDR.
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Dan O'Leary
Swanzey NH
United States
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