Our first “Ask us Anything” webinar last week focused on the topic of Unique Device Identification (UDI). We had so many great questions that we couldn’t answer them all during the session! We have picked the most common questions and put them together here with the answers from our expert panel.
For additional information on this topic, see the following resources:
Yes, that is true. The European Commission recently pushed back EUDAMED deadlines by one year. It is important to note that this does not affect UDI labeling requirements and timeframes, only the mandatory entry of UDI data attributes into EUDAMED (now Q2 2026). The industry should not relax their efforts in regards to collecting and submitting UDI data. We make every effort to keep our Quick reference guide: global UDI requirements and timelines up-to-date and deadlines and regulations change.
Following this session, the FDA announced that they do not intend to enforce GUDID submission requirements for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining devices.
While the manufacturer is responsible for the accuracy of data they input into GUDID, the FDA is the agency that oversees the requirements.
To fully answer this question, we might need a little more information. However, if the device involved in the clinical study is not released (i.e. marketed), then it would not require a UDI. If additional features are introduced during the clinical trial and a new product is released as a result, then a new UDI would be required.
Currently, the U.S. UDI database, GUDID, has the capability to accept machine-to-machine data transmission. More information can be found on the FDA website here. Most other major markets are working on providing this capability.
This is a broad question and there could be many different answers based on your product, QMS, and company structure. Generally speaking:
Main things to consider:
The FDA regulations and data dictionary are mature and include information and required data fields to complete successful transmission of data. Data field details include information on whether data is required or conditional on other data, lists of standardized values, and guidance on the data that is expected for each field. EUDAMED has taken a similar approach, and also includes information that is expected for BUDI. The EUDAMED data dictionary is still in flux. We expect a similar approach from other countries.
Generally, the UDI is assigned at the lowest sellable product level. In the case of kits, procedure packs, or systems - each would be given a unique UDI as well.
There is no GUDID barcode, but the information on the UDI barcode is contained within the GUDID database. The barcode or human-readable numbers provide high level information about the device. They act as an access key to all of the device attribute data within the GUDID database. The expected barcode on the product is the full UDI including the device identifier (DI) and the production identifier (PI). The GUDID is the FDAs regulatory database where labelers are required to submit information about the UDI DI.