What about the Successor Organisation (IMDRF) of the GHTF?

In one of our News from 29 January 2013 we reported about the end of the Global Harmonisation Task Force (GHTF) and presented the International Medical Device Regulators Forum (IMDRF) as successor organisation. For a start, the IMDRF has taken over the "old" GHTF guidelines and plans to develop them further successively where necessary. First efforts have now been made. A current stand is available on the IMDRF website in the section "Consultations".

Some consultations are already closed (by the end of 2012 and June 2013) regarding the following documents:

  • Regulated product submissions (RPS) Table of Contents
  • Auditor competency and training requirements for organizations undertaking audits of medical devices manufacturers
  • Recognition and monitoring of organizations undertaking audits of medical devices manufacturers
  • Recognition Criterial for Medical Devices Auditing Organizations

The last three documents belong to a working group called Medical Device Single Audit Program (MDSAP) and should be helpful - when finalised - regarding GMP aspects in the context of audits.

The following consultations are still open until the end of August:

  • Standalone Software: Key Definitions
  • Assessor competency and training requirements for Regulatory Authorities undertaking assessments for auditing organizations
  • Regulatory Assessment Programme and Assessment Strategy utilizing for the recognition and monitoring of medical device auditing organizations
  • UDI System for Medical Devices

These documents are still accessible and can be commented.

You can find the overview of the consultations on the IMDRF webpage.

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