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
Terminologies for Categorized Adverse Event Reporting: Terms, terminology structure and codes Adverse Event Terminology Hiroshi Ishikawa 12 October 2018
Principles of Labeling for Medical Devices and IVD Medical Devices Good Regulatory Review Practices Melissa Torres 12 September 2018
Unique Device Identification system (UDI System) UDI Salvatore Scalzo 12 October 2018

Closed consultations

In this section: Adverse Event Terminology 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
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

Good Regulatory Review Practices Working Group

Consultation item Working Group Coordinator Closing date
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
UDI System for Medical Devices Unique Device Identification system (UDI) Working Group Mr Laurent Sell├ęs 31 August 2013