IMDRF Finalizes UDI Rule, Five Other Device-Related Documents

| 19 December 2013 | By Alexander Gaffney, RAC, 

The International Medical Device Regulators Forum (IMDRF) has announced the finalization of six documents pertaining to the marking of devices with unique identifiers, standardized definitions for medical software and extensive requirements for auditors participating in the single audit program.

The IMDRF, launched in early 2013, is the regulators-only successor to the Global Harmonization Task Force (GHTF), a harmonization group that disbanded in 2012. Its current membership includes the US, EU, Japan, Canada, Brazil and Australia.

One of the reasons for disbanding GHTF in favor of IMDRF was the speed at which the latter hoped to work. Industry, regulators felt, had been slowing the pace at which they could release new documents. The new group, by contrast, would allow industry to participate as observers, but not as full voting members.

And true to its promise, IMDRF has been working quickly to finalize many documents. On 18 December 2013, it announced that six documents had been finalized:

• UDI Guidance: Unique Device Identification (UDI) of Medical Devices
  • (Focus explanation of draft document)
• Software as a Medical Device (SaMD): Key Definitions
  • (Focus explanation of draft document)
• Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition
  • (Focus explanation of draft document)
• Competence and Training Requirements for Auditing Organizations
  • (Focus explanation of draft document)
• Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations
  • (Focus explanation of draft document)
• Regulatory Authority Assessor Competence and Training Requirements
  • (Focus explanation of draft document)

It will now be up to the IMDRF member countries to harmonize their existing regulations to the new standards, if they haven't already.

IMDRF Documents List