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Consultations

Current consultations

IMDRF is currently reviewing the following consultations:

Consultation item Working Group Coordinator Closing date
There are currently no current consultations available for comment

Closed consultations

Consultation item Working Group Coordinator Closing date
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 Standalone Medical Device Software 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 Standalone Medical Device Software 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