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Work items

Current work items

IMDRF is currently progressing the following work items:

Work item Working Group Membership Coordinator
Unique Device Identification (UDI) Application Guide Regulatory and stakeholder membership Coordinator - Salvatore Scalzo, European Union
Personalized Medical Devices Regulator membership Dr Elizabeth McGrath, Australia
Standards - Improving the quality of international medical device standards for regulatory use Regulatory and stakeholder membership Scott A Colburn, USA
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
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