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Work items

Current work items

IMDRF is currently progressing the following work items:

Work item Working Group Membership Coordinator
Artificial Intelligence Medical Devices (AIMD) Regulators and stakeholder membership Dr Young-kyu Kang, MFDS, South Korea
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification Regulator and Regional Initiatives membership Tatyana Buryakina, Roszdravnadzor, Russia
Medical Device Cybersecurity Guide Regulator and stakeholder membership (membership to be advised) Suzanne Schwartz, US FDA
Marc Lamoureux, Health Canada
Medical Device Clinical Evaluation Regulatory and stakeholder membership Dr Yinghui Liu, China
Personalized Medical Devices Regulator membership Tracey Duffy, Australia
Adverse Event Terminology Regulator membership Hiroshi Ishikawa, Japan
Good Regulatory Review Practices Regulator membership Melissa Torres, USA
Regulated Product Submission Regulator only and regulator and stakeholder membership Nancy Shadeed, Canada

Closed work items

Work item Working Group Membership Coordinator
Standards - Improving the quality of international medical device standards for regulatory use Regulatory and stakeholder membership Scott A Colburn, USA
Unique Device Identification (UDI) Application Guide Regulatory and stakeholder membership Coordinator - Salvatore Scalzo, European Union
Patient Registries Regulator and stakeholder membership Danica Marinac-Dabic, USA
Software as a Medical Device Regulator and stakeholder membership Bakul Patel, USA
A review of the NCAR system Regulator membership Jean-Francois Roche, Europe
Medical Device Single Audit Program (MDSAP) Regulator membership Kimberly Trautman, USA
IMDRF recognized standards No Working Group required for initial information gathering phase Matthias Neumann, Europe
Roadmap for implementation of UDI system Regulator and stakeholder membership Laurent Selles, Europe