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    2. International Medical Device Regulators Forum logo
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      Work items

      Current work items

      IMDRF is currently progressing the following work items:

      Work item Working Group Membership Coordinator
      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 Dr Elizabeth McGrath, 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
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