Patient problem adverse event codes published

Posted on 06.06.2019

The adverse event codes developed by the International Medical Device Regulators Forum (IMDRF) are scheduled to be implemented in the European vigilance reporting starting from 1 January 2019 with a one-year transition period until their official enforcement as of 1^st January 2020.

Now a new set of IMDRF adverse event codes were published for Patient outcome / Patient problem which are available at the IMDRF website here. For this new set of codes, the one-year transition time starts in June 2019.

Manufacturers should map their internal company codes to the IMDRF adverse event codes:

Event-type codes (published in April 2017)

• IMDRF Medical device problem codes (Annex A) + reference mapping

Evaluation codes / IMDRF Cause investigation (published in October 2017)

• Type of investigation (Annex B – 1 level) + reference mapping
• Investigation findings (Annex C – 3 levels) + reference mapping
• Investigation conclusion (Annex D – 2 level) + reference mapping

Patient outcome codes / IMDRF Patient Problem (published in June 2019)

• Clinical signs, symptoms, and conditions (Annex E)
• Health impact (Annex F)

IMDRF Component codes (planned publication ~in Q2 2020)

• Component codes (Annex G) – public consultation