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Consultations

Current consultations

IMDRF is currently reviewing the following consultations:

Consultation item Working Group Coordinator Closing date
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
UDI System for Medical Devices Unique Device Identification system (UDI) Working Group Mr Laurent Sellés 31 July 2013

Closed consultations

Consultation item Working Group Coordinator Closing date
Recognition Criteria for Medical Device Auditing Organizations Medical Device Single Audit Program (MDSAP) Working Group Kim Trautman 14 December 2012