Unique Device Identification FAQ
Q: What is UDI or Unique Device Identification?
A: UDI aids in the traceability of medical devices in Europe, promoting safety and enabling effective post-market surveillance. It also originated from the IMDRF guidance and is similar to the UIN used in the USA.
Q: What is the purpose of UDI in Europe?
A: UDI aids in the traceability of medical devices in Europe, promoting safety and enabling effective post-market surveillance. It also originated from the IMDRF guidance and is similar to the UIN used in the USA.
Q: What is the Basic UDI-DI?
A: Basic UDI-DI is an identification number for a group of products sharing common characteristics, such as intended purpose, risk class, essential design, and manufacturing characteristic. It serves administrative purposes and appears on certificates, declarations, technical documentation, etc.
Q: Where can I get the Basic UDI-DI and in what format?
A: An official designated entity provides the Basic UDI-DI. Entities like GS1, HIBCC, ICCBBA, and IFA GmbH have been designated by the European Commission. The UDI format should be in compliance with the issued guidelines.
Q: What is the difference between UDI-DI and Basic UDI-DI?
A: UDI-DI is specific to a single medical device product, while Basic UDI-DI applies to a group of products with shared characteristics. Basic UDI-DI is used for administrative purposes, while UDI-DI is used for individual product identification.
Q: Do I need a different UDI-DI for each version of my product?
A: Yes, each version of a product, even if they are identical, requires a separate UDI-DI. For example, a product with different packaging quantities or states (sterile/non-sterile) will have different UDI-DIs but the same Basic UDI-DI.
Q: Where should I place the UDI on my product?
A: The UDI should be displayed on the device label and all upper-level packaging where it can be seen by users. For certain cases, the UDI can be placed on the next higher packaging if individually packed class I and IIa single-use devices.
Q: What are the implementation dates for UDI requirements?
A: The implementation dates for UDI requirements depend on the risk class of the medical device: Class III and implantable devices should have implemented UDI by 26th May 2021, Class IIa and IIb by 26th May 2023, and Class I by 26th May 2025.
Q: What is the UDI format for combination products?
A: Combination products incorporating a medical device and a pharmaceutical must adhere to UDI criteria, while products covered solely under the Medicinal Directive 2001/83/EC are exempt from UDI requirements.
Q: Is UDI mandatory for standalone software products?
A: Standalone software within the scope of Annex 6 Part-C paragraph 6 of the EU MDR requires an UDI. The software UDI consists of UDI-DI for generic software information and UDI-PI for manufacturing parameters.
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