IMDRF Round Up: Forum Plans Guidance on UDIs, SaMD
The International Medical Device Regulators Forum plans to develop guidance on a global unique device identification (UDI) system to help ease the regulatory burden on manufacturers selling medical devices in more than one country.
The document will focus on UDI assignment rules, the structure and format, specifications for device identifier core data elements, and on general principles for exceptions or alternatives when UDI marking is not feasible.
IMDRF members discussed the planned guidance at the forum’s meeting in Vancouver, Canada. The European Commission will chair a work group that will lead the development of the UDI guidance.
Unresolved issues with existing UDI rules in the U.S. and elsewhere have presented obstacles to harmonization. For example, the device industry says the FDA needs to revise its UDI rule to clarify how to label devices with multiple components and when design changes require a new UDI.