The article provides a general overview of the key terms and concepts used in adverse event reporting related to medical devices.
Table Of Contents:
The International Medical Device Regulators Forum, an organization comprised of national regulating authorities collaborating further to improve the existing regulatory framework for medical devices, has published a guide dedicated to the terminologies for categorized Adverse Event Reporting (AER). The document describes the relevant terms, terminology structures, and codes.
The International Medical Device Regulators Forum has issued a present guidance document based on the output of the collaborative efforts of its Adverse Event Working Group.
This initiative seeks to establish a globally harmonized terminology and coding system for reporting adverse events related to medical devices, including in-vitro diagnostics (IVDs).
The primary objective is to enhance the efficiency and accuracy of adverse event management systems. This will, in turn, facilitate quicker and more effective responses from both the industry and regulatory authorities.
As it is stated in the document, the adoption of a unified system of terminology and coding for adverse events offers several advantages.
It elevates the precision in capturing and reporting incidents related to medical devices and minimizes ambiguity, thus streamlining the evaluation process.
Furthermore, this structured approach enables more sophisticated signal detection methodologies and trending analysis, ultimately accelerating the response time of both regulatory bodies and device manufacturers.
Use of the Adverse Event Reporting Terminology
The guidance document delineates the IMDRF terms, definitions, and alphanumeric codes for adverse event reporting concerning medical devices and in vitro diagnostics, encompassing pre-market and post-market contexts.
It clarifies that individual regulatory authorities determine the criteria for reporting adverse events and are beyond the purview of this document.
The guidance refers to documents from respective jurisdictions and the GHTF document on Post Market Surveillance for further clarification.
Intended End-Users
The terminologies proposed are intended for use by entities obliged to report adverse events to authorities, following the regulatory frameworks of their respective jurisdictions.
This includes the reporters of adverse events and the regulatory authorities responsible for collecting, processing, and analyzing such data. The ultimate goal is to improve patient and public health protection.
References
The development of this guidance document is based on an array of reference materials.
These include various ISO technical specifications providing a hierarchical coding structure for adverse events, the MedDRA Web-Based Browser, and the NCI Term Browser, among others.
Documents from the Global Harmonization Task Force (GHTF) on labeling, post-market surveillance, the electronic transfer of adverse event data, and FDA MDR Adverse Event Codes were also considered.
Benefits of a Harmonized Terminology
As explained by the IMDRF, the harmonization of terminology and coding for adverse event reporting extends multiple benefits across the healthcare and regulatory ecosystem:
- For Manufacturers and Distributors: It streamlines the reporting process to multiple jurisdictions, easing the administrative burden and fostering consistency.
- For Regulatory Authorities: Common terms and definitions enhance the accuracy and reliability of safety, quality, and performance analyses, facilitating global sharing and potentially expediting the detection of safety signals.
- For Patients: A unified system ensures a more rapid local and international response to adverse events, contributing to enhanced patient safety.
- For Healthcare Providers: The adoption of common terminology improves the accuracy, reliability, and utility of adverse event reports, particularly when larger datasets are involved, thereby aiding in comprehensive analyses.
Conclusion
In summary, the present IMDRF guidance document represents a significant step forward in the global effort to standardize the reporting of adverse events related to medical devices. By adopting a unified terminology and coding system, the document aims to improve the efficacy of adverse event management systems, thus ensuring a quicker and more efficient response from all stakeholders involved. This initiative enhances patient safety and contributes to the integrity and reliability of the medical device industry’s regulatory framework.
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