This document has been prepared by the IMDRF Adverse Event Terminology Working Group (AET WG), charged with developing a harmonized terminology for reporting adverse events related to medical devices including in-vitro diagnostics (IVDs).
Since GHTF SG2/N54 (Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices) was published in 2006, most GHTF members implemented adverse event reporting systems aligning with the general principles of N54. Building on the work of N54, the IMDRF AET WG developed globally harmonized terminology and codes for product problem, cause investigation, health effects, and components (IMDRF/N43). Widespread use of a single, appropriate adverse event terminology and coding system is expected to improve signal detection and validation by adverse event management systems enabling a faster response by both industry and regulatory authorities for public health safety.
As both regulators and industry work towards implementation of IMDRF terminology, an important next step is establishing a “Common Data Set” (CDS) for global adverse event report information exchange, so that all stakeholders can utilize the full potential of the IMDRF Terminology for signal detection and trend analysis (similar to the ICH E2B standard in pharmacovigilance). Therefore, following the completion of all IMDRF Terminology (IMDRF/N43: Edition 4 2020) and outlining the process for future maintenance, (IMDRF/N44: Edition 3 2020), the group has started the process toward a CDS by reviewing the current adverse event reporting datasets collected by representative IMDRF member jurisdictions to develop a common data set for data
exchange as well as guidelines for the exchange of adverse event data between regulators. This CDS will then be used to by regulators to exchange data for signal detection, with the aim of expanding it to the final goal of a harmonised CDS for global adverse event reporting.
This document is not defining how to detect and validate signals or how the jurisdictions should manage them. This document only applies to the actual exchange of adverse event data, based on the common data set.