OneThe basic concept of UDI
As the number of medical devices continues to grow, tracking and identifying them becomes a challenge and the reason for establishing a globally recognized Unique Device Identification (UDI) system.
UDI is a unique numeric or alphanumeric number assigned to a medical device and consists of two parts: the Device Identification (DI) and the Manufacturing Identification (PI).
DL is fixed** and is used to identify the make, make, and model of the device.
PL is variable** and contains information such as lot number, serial number, and expiration date.
IIUDI requirements and timelines
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The U.S. UDI system was established by the FDA in 2013.
The FDA requires medical device manufacturers to assign UDI to their devices and submit them to the Global Unique Device Identification Database (GUDID).
The deadline for enforcing the UDI regulation varies according to the risk classification of the device, as shown in the table below
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The EU UDI system was established by the European Commission in 2013.
The European Union Medical Device Regulation (EU MDR) requires medical device manufacturers to assign a UDI to their devices and submit them to the European Medical Device Database (EUDAMED).
The EU MDR has a transition period from 2017 to 26 May 2023. The transition period has ended, and manufacturers should ensure that devices meet UDI requirements before they can be placed on the market.
Canada
Health Canada has proposed to establish a UDI system that strictly follows the IMDRF Global UDI Guidelines. The proposed system requires all devices except Class I low-risk devices to have a UDI label.
Health Canada plans to create a new UDI database or modify an existing MDALL database to include UDI information. It is expected that Canada may introduce additional UDI data elements based on its needs.
Australia
The Australian UDI system was established in 2019 by the Supplies Administration (TGA).
Medical device manufacturers are required to assign a UDI to their device and submit it to the Australian Medical Device Database (ADMD).
The deadline for implementation of the UDI regulations is July 1, 2022, for Class III and implantable devices, and July 1, 2023 for other medical devices.
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Japan's UDI system was established by the Ministry of Health, Labor and Welfare.
Medical device manufacturers are required to assign UDIS to their devices and submit them to the Japan Medical Device Information System (J-MED Net).
The deadline for the implementation of the UDI regulations is December 1, 2022, for Class III devices, and December 1, 2023 for all other medical devices.
For medical device manufacturersBe aware of and comply with applicable UDI requirements to avoid penalties and ensure patient safety, which is particularly important.