9 September 2021

Resgistration is now Closed

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IMDRF/DITTA Joint Workshop on UDI

Unique Device Identifiers (UDIs) serve important regulatory and supply chain functions for medical devices. They allow for tracking of devices throughout the global supply chain to the patient and provide global visibility to device adverse event reporting and a better means to perform post-market surveillance, thereby enhancing patient safety.
Increasingly, UDI requirements such as Device Identifier triggers (rules requiring creation of a new Device Identifier) are not globally harmonized which is causing a proliferation of Device Identifiers to be created and registered globally.  It is also noted that jurisdiction-specific concepts exist such as ‘Basic UDI-DI’ and other developing concepts such as ‘Master UDI-DI’.
   The COVID-19 Pandemic has shown the importance of quickly distributing medical devices and of removing barriers to such market access. Harmonization of UDI is an opportunity to facilitate this distribution.
   Now, more than two years since IMDRF published its UDI Application Guide. This is a good moment to assess the implementation of UDI in the regulations of the IMDRF member jurisdictions and to draw attention to ensure its harmonization.

Workshop Objectives
•    Provide an overview of IMDRF work on UDI
•    Better understand how the IMDRF UDI guidance documents are implemented in various jurisdictions
•    Evaluate the experience of industry and other stakeholders when applying UDI for medical devices, including how UDI is used by healthcare providers
•    Exchange views on how UDI can be better implemented towards global convergence