<samp id="nqpwb"></samp>
  • <bdo id="nqpwb"></bdo>
  • <p id="nqpwb"><label id="nqpwb"><menu id="nqpwb"></menu></label></p>

    <td id="nqpwb"><ruby id="nqpwb"></ruby></td>

      <acronym id="nqpwb"><label id="nqpwb"><address id="nqpwb"></address></label></acronym>
    1. <p id="nqpwb"><del id="nqpwb"><menu id="nqpwb"></menu></del></p>

    2. International Medical Device Regulators Forum logo
      A- A+ print this page

      Consultations

      Current consultations

      IMDRF is currently reviewing the following consultations:

      Consultation item Working Group Coordinator Closing date
      Principles of In Vitro Diagnostic (IVD) Medical Devices Classification In vitro diagnostics Tatyana Buryakina 25 July 2020
      Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Good Regulatory Review Practices Melissa Torres 26 May 2020
      Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies Good Regulatory Review Practices Melissa Torres 9 May 2020

      Closed consultations

      In this section: Adverse Event Terminology Working Group | Cybersecurity Working Group | Good Regulatory Review Practices Working Group | Medical Device Single Audit Program Working Group | National Competent Authority Report Working Group | Patient Registries Working Group | Personalized Medical Devices Working Group | Regulated Product Submission Working Group | Software as a Medical Device Working Group | Standards Working Group | Unique Device Identification System Working Group

      Adverse Event Terminology Working Group

      Consultation item Working Group Coordinator Closing date
      Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Good Regulatory Review Practices Melissa Torres 3 October 2019
      IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex А (Edition 3), G IMDRF Adverse Event Terminology Working Group Hiroshi Ishikawa 10 September 2019
      Personalized Medical Devices - Regulatory Pathways Personalized Medical Devices Elizabeth McGrath 24 July 2019
      Proposed update to Clinical Evaluation documents Medical Device Clinical Evidence Liu Yinghui 5 June 2019
      Terminologies for Categorized Adverse Event Reporting: Terms, terminology structure and codes Adverse Event Terminology Hiroshi Ishikawa 12 October 2018
      IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes - Annex B Adverse Event Terminology Hiroshi Ishikawa 31 May 2017
      IMDRF Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology structure and codes Adverse Event Terminology Hiroshi Ishikawa 2 December 2016

      Cybersecurity Working Group

      Consultation item Working Group Coordinator Closing date
      IMDRF Principles and Practices for Medical Device Cybersecurity Medical Device Cybersecurity Working Group Suzanne Schwartz and Marc Lamoureux 2 December 2019

      Good Regulatory Review Practices Working Group

      Consultation item Working Group Coordinator Closing date
      Principles of Labeling for Medical Devices and IVD Medical Devices Good Regulatory Review Practices Melissa Torres 12 September 2018
      Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices Good Regulatory Review Practices Melissa Torres 18 April 2018
      Competence, Training and Conduct Requirements for Regulatory Reviewers Good Regulatory Review Practices Melissa Torres 14 October 2016

      Medical Device Single Audit Program Working Group

      Consultation item Working Group Coordinator Closing date
      MDSAP - Guidance on Regulatory Authority Assessment Methods of Auditing Organization's Processes Medical Device Single Audit Program Ms Kimberly Trautman 1 June 2015
      MDSAP - Medical Device Regulatory Audit Reports Medical Device Single Audit Program Ms Kimberly Trautman 1 June 2015
      MDSAP Assessment Outcomes and Recognition/Re-recognition Decision by Regulatory Authorities Medical Device Single Audit Program Ms Kimberly Trautman 31 May 2014
      Assessor competency and training requirements for Regulatory Authorities undertaking assessments of auditing organizations Medical Device Single Audit Program Ms Kimberly Trautman 30 August 2013
      Regulatory Assessment Program and Assessment Strategy utilizing for the recognition and monitoring of medical device auditing organizations Medical Device Single Audit Program Ms Kimberly Trautman 30 August 2013
      Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers Medical Device Single Audit Program Ms Kimberly Trautman 14 June 2013
      Recognition and monitoring of organizations undertaking audits of medical device manufacturers Medical Device Single Audit Program Ms Kimberly Trautman 14 June 2013
      Recognition Criteria for Medical Device Auditing Organizations Medical Device Single Audit Program Kim Trautman 14 December 2012

      National Competent Authority Report Working Group

      Consultation item Working Group Coordinator Closing date
      Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form National Competent Authority Report Mr Jean-Francois Roche 8 December 2014

      Patient Registries Working Group

      Consultation item Working Group Coordinator Closing date
      Tools for Assessing the Usability of Registries in Support of Regulatory Decision Making Patient Registries Danica Marinac-Dabic 1 December 2017
      Methodological Principles in the Use of International Medical Device Registry Data Patient Registries Danica Marinac-Dabic 2 December 2016
      Patient Registry: Essential Principles Patient Registries Dr Danica Marinac-Dabic 18 January 2016

      Personalized Medical Devices Working Group

      Consultation item Working Group Coordinator Closing date
      Definitions for Personalized Medical Devices Personalized Medical Devices Working Group Elizabeth McGrath 24 May 2018

      Regulated Product Submission Working Group

      Consultation item Working Group Coordinator Closing date
      RPS Table of Contents Pilot Regulated Product Submission Daniel Yoon 20 March 2018
      RPS - Common Data Elements for Medical Device Identification Regulated Product Submission Ms Nancy Shadeed 15 September 2015
      Request for expressions of Interest to participate in the IMDRF TOC pilot plan Regulated Product Submission Ms Nancy Shadeed 21 August 2015
      Regulated Product Submission - Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions Regulated Product Submission Ms Nancy Shadeed 1 June 2015
      In-Vitro Diagnostics Market Authorization Table of Contents Regulated Product Submission Mr Mike Ward 17 January 2014
      Regulated product submission (RPS) Table of contents Regulated product submission (RPS) Working Group Mr Mike Ward 21 June 2013

      Software as a Medical Device Working Group

      Consultation item Working Group Coordinator Closing date
      Software as a Medical Device (SaMD): Clinical Evaluation Software as a Medical Device Bakul Patel 13 December 2016
      Software as a Medical Device (SaMD): online survey now open Software as a Medical Device Mr Bakul Patel 3 August 2015
      Software as a Medical Device (SaMD): Application of Quality Management System Software as a Medical Device Mr Bakul Patel 1 June 2015
      Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls Software as a Medical Device Mr Bakul Patel 31 May 2014
      Standalone Software: Key Definitions Software as a Medical Device Mr Bakul Patel 30 August 2013

      Standards Working Group

      Consultation item Working Group Coordinator Closing date
      Optimizing Standards for Regulatory Use Standards Working Group Scott Colburn 24 May 2018

      Unique Device Identification System

      Consultation item Working Group Coordinator Closing date
      Unique Device Identification system (UDI System) Unique Device Identification system (UDI) Working Group Salvatore Scalzo 12 October 2018
      UDI System for Medical Devices Unique Device Identification system (UDI) Working Group Mr Laurent Sellés 31 August 2013
      炸三张