The International Medical Device Regulators Forum (IMDRF) held its 25th annual meeting in Washington, DC on March 12, 2024. Of the topics discussed was the progress of the various working groups and the mention of new guidance documents harmonizing global marketing review requirements, which is highly sought after by industry.
Working groups that were highlighted in the session included:
- Adverse Events Terminology
- Good Regulatory Review Practices
- Personalized Medical Devices
- Quality Management System
The Adverse Events Terminology Working Group is helping to better identify coding used in adverse events processes. As a matter of harmonization, adverse event reporting is paramount when considering common data points between jurisdictional areas. The Good Regulatory Review Practices Working Group is aimed at ensuring marketing review consistency of which Canada has already taken steps to pilot the eSTAR project. In another area, several regulators are developing guidance in the Artificial Intelligence/ Machine Learning Working Group as advances in AI/ML technology continues to rapidly expand.
Technological advances in manufacturing and materials science are giving rise to more personalized medical devices or PMDs and a shift to point-of-care processing, although it also raises the levels of risk. The Personalized Medical Devices Working Group is developing training materials and technical guidance to address these issues.
As the world focuses on the recently released long-awaited QMSR, the Quality Management System Working Group continues its focus to refine the work of the former Global Harmonization Task Force (GHTF) and the Software as a Medical Device (SaMD) Working Group. This group is very active in updating various documents and focusing on more succinct characterization of medical device software.
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