IMDRF Concludes Inaugural Meeting, Looks to Assume GHTF Duties
Posted 15 March 2012 | By
The International Medical Device Regulators Forum (IMDRF), the regulators-only presumed successor organization to the Global Harmonization Task Force (GHTF), concluded its first meeting on 1 March.
Roughly 100 participants were involved in formulating operational plans, planning the transition of GHTF functions to IMDRF, adopting a work plan and engaging in dialogue.
IMDRF members seem to be grappling with how much value to place on existing GHTF output, including GHTF documents, how to establish partnerships with affiliate organizations, how to engage with industry and what role industry will play in the future development of the organization.
IMDRF said it hopes to be able to deliver results within 18 months, particularly related to "regulatory convergence and promoting access to safe and effective medical devices globally."
Other topics the forum hopes to address:
- A review of the National Competent Authority Report (NCAR) system
- Roadmap for implementation of a Unique Device Identification (UDI) system
- Standardized submission requirements for pre-market assessment of medical devices
- Medical Device Single Audit Program (MDSAP)
- Non-clinical and clinical evaluation regarding nanomaterials
- International standards recognized by IMDRF Management Committee members
- Guidance on how to determine benefit:risk analysis
- Regulated Product Submission
IMDRF - IMDRF meetings
Outcome Statement - Meeting 1, 28 February to 1 March 2012
Media statement - Successful launch to the IMDRF, March 2012