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Consultations

Current consultations

IMDRF is currently reviewing the following consultations:

Consultation item Working Group Coordinator Closing date
RPS - Common Data Elements for Medical Device Identification Regulated Product Submission (RPS) Working Group Ms Nancy Shadeed 15 September 2015
Request for expressions of Interest to participate in the IMDRF TOC pilot plan Regulated Product Submission (RPS) Working Group Ms Nancy Shadeed 21 August 2015
Software as a Medical Device (SaMD): online survey now open Software as a Medical Device Working Group Mr Bakul Patel 3 August 2015

Closed consultations

Consultation item Working Group Coordinator Closing date
Regulated Product Submission - Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions Regulated Product Submission Table of Contents Working Group Ms Nancy Shadeed 1 June 2015
MDSAP - Guidance on Regulatory Authority Assessment Methods of Auditing Organization's Processes Medical Device Single Audit Program Working Group Ms Kimberly Trautman 1 June 2015
MDSAP - Medical Device Regulatory Audit Reports Medical Device Single Audit Program Working Group Ms Kimberly Trautman 1 June 2015
Software as a Medical Device (SaMD): Application of Quality Management System Software as a Medical Device Working Group Mr Bakul Patel 1 June 2015
Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form National Competent Authority Report (NCAR) Working Group Mr Jean-Francois Roche 8 December 2014
MDSAP Assessment Outcomes and Recognition/Re-recognition Decision by Regulatory Authorities Medical Device Single Audit Program Working Group Ms Kimberly Trautman 31 May 2014
Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls Software as a Medical Device Working Group Mr Bakul Patel 31 May 2014
In-Vitro Diagnostics Market Authorization Table of Contents Regulated Product Submission, Table of Contents Working Group Mr Mike Ward 17 January 2014
Standalone Software: Key Definitions Software as a Medical Device Working Group Mr Bakul Patel 30 August 2013
Assessor competency and training requirements for Regulatory Authorities undertaking assessments of auditing organizations Medical Device Single Audit Program Working Group 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 Working Group Ms Kimberly Trautman 30 August 2013
UDI System for Medical Devices Unique Device Identification system (UDI) Working Group Mr Laurent Sell├ęs 31 August 2013
Regulated product submission (RPS) Table of contents Regulated product submission (RPS) Working Group Mr Mike Ward 21 June 2013
Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers Medical Device Single Audit Program (MDSAP) Working Group Ms Kimberly Trautman 14 June 2013
Recognition and monitoring of organizations undertaking audits of medical device manufacturers Medical Device Single Audit Program (MDSAP) Working Group Ms Kimberly Trautman 14 June 2013
Recognition Criteria for Medical Device Auditing Organizations Medical Device Single Audit Program (MDSAP) Working Group Kim Trautman 14 December 2012