The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs

IMDRF Management Committee Adopts MDSAP Guidances, Two New Work Items

Dec. 13, 2013

The International Medical Device Regulators Forum adopted four final guidance documents and two new work items relating to the Medical Device Single Audit Program during a meeting in Brussels last month.

The MDSAP pilot is set to launch next month in the U.S., Canada, Australia and Brazil. The program will run for three years in pilot phase and has the potential to overhaul inspection and enforcement activities in the participating countries.

The final guidances are:

  • Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition;

  • Competency and Training Requirements for Auditing Organizations;

  • Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations; and

  • Regulatory Authority Assessor Competency and Training Requirements.

Added to the drawing board are a guidance on regulatory authority assessment methods, which will cover information extracted from the N5 guidance, and a new document on auditing organization assessments, recognition and remediation.

Also adopted was a revised document on the Unique Device Identification (UDI) System for Medical Devices.

The committee agreed to publish a list of recognized standards on the IMDRF website, endorsed the table of contents for in vitro diagnostic devices and adopted the guidance, Software as a Medical Device (SaMD): Key Definitions.

The committee’s next meeting is in March in San Francisco and will be chaired by the FDA.

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