GHTF publishes Guidance on Globally Harmonised Identification of Medical Devices

On 16 September 2011, the Global Harmonisation Task Force (GHTF) published the final version of a guidance entitled "Unique Device Identification (UDI) System for Medical Devices".

The purpose of this document is to provide a framework for regulatory authorities that want to develop their own UDI System. The aim is to achieve a global harmonised UDI System.

Through this guidance, It is expected that the regulatory authorities follow the requirements expressed in it so that no regional or national differences remain.

However, it is conceded that this guidance (only) provides a high-level conceptual view of how a global UDI System should work. Additional guidance may be needed.

The single identification system should increase the patient safety, especially:

  • The traceability of medical devices (for recalls) 
  • Adequate identification of the medical devices through its distribution and use 
  • Identification of devices in adverse events 
  • Reduction of medical errors 
  • Documentation - for example for patient records

Please also see the guidance entitled "Unique Device Identification (UDI) System for Medical Devices".

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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