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Medical Devices / Regulatory Affairs

IMDRF Seeks Feedback on Adverse Event Reporting Terms

Aug. 26, 2019

The International Medical Device Regulators Forum (IMDRF) has issued a new draft document on harmonizing terminology and codes for reporting adverse events for medical devices and in vitro diagnostics.

The forum’s Adverse Event Terminology Working Group says a single adverse event terminology and coding system will improve signal detection and enable faster responses by industry and regulators.

Using defined terms and codes would help identify potential risks sooner and allow sophisticated trending analyses among global regulators, the group said.

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