FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

IMDRF Issues Final Guidance on Adverse Event Reporting Terms

April 19, 2017
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The International Medical Device Regulators Forum has released final guidance on harmonized terminology for reporting adverse events related to medical devices and IVDs.

The use of a single terminology and coding system should improve signal detection by AE management systems, allowing a faster response by industry and regulatory agencies, IMDRF says.

IMDRF’s Adverse Event Working Group has defined four distinct sets of terminologies and their associated alphanumeric codes: medical device problem, cause investigation, patient problem, and component. The working group advises coding to the most detailed level possible in agreement with the requirements of relevant jurisdictions.

The sets of terminologies are intended for use by reporters of AEs, in accordance with regulations in each jurisdiction. The terminologies are also for use by regulatory authorities—which may be national or supranational bodies charged with monitoring and analyzing AEs.

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