IMDRF Opens Consultations on AERs, Principles for Labeling and UDIs

IMDRF’s Adverse Event Terminology Working Group is seeking comments on proposals to harmonize terminology globally for reporting adverse events for medical devices and in vitro diagnostics.

The use of a single adverse event terminology and coding system is expected to improve signal detection by adverse event management systems to allow faster responses by both industry and regulators. Using defined terms and associated codes will help identify potential risks sooner and allow sophisticated trending analyses among global regulators.

The working group released updated IMDRF terminologies for categorized AERs in September 2017. The new consultation covers additional annexes on health effects terms and conditions based on FDA terms and it refers to MedDRA. An annex on components is still under development.