What is UDI-DI?
UDI stands for Unique Device Identification. The labels of medical devices contain a UDI that can be found and read by both people and machines. The UDI contains both numbers and letters in a prescribed sequence. This includes the Device Identifier identifying the product and company, and the Production Identifier. The unique device identification system ensures common standards for medical devices globally. Both the Food and Drug Administration (FDA) in the United States, and the European Union (EU EUDAMED) have established requirements for the UDI systems they have created.
UDI enhances patient safety by identifying each product with a static device identifier denoting the device labeler and the specific model or version of a device and the dynamic product identifier which identifies the expiration date, serial number, manufactured date or the lot/batch number of the device. While the UDI is created through the guidelines of an approved issuing agency, the medical device manufacturer is responsible for performing a submission of the identifier along with several product data attributes. These requirements were implemented to improve the safety of patients and facilitate product modernization. By requiring widespread use, both the FDA and EU have helped ensure patient safety and have allowed for the tracking of medical devices during post-market use. The UDI helps promote medical device innovation that will benefit patients down the road.
How Does the UDI-DI System Work in the EU?
In 2019, the (EU) designated GS1 as the entity responsible for issuing UDI's to medical devices. Because of the GS1 standards and regulations, global healthcare companies can create medical devices that meet those standards and will be acceptable for use by companies in the EU. Any required regulatory product information is submitted to EUDAMED. EUDAMED is the IT database that stores and regulates medical devices in the European Union and industry activity is underway leading up to a full launch anticipated in May 2022.
The EUDAMED database is similar to the FDA in the United States, however it requires more product data attributes and the concept of basic unique device identification or BUDI-DI. BUDI is the main identifier of a model, while the DI is the specific device unit.
How is UDI different from BUDI-DI?
When it comes to EU declarations of conformity, BUDI-DI is a critical main key for EUDAMED device registration and UDI database records. Below is an example:
For medical device registration in the EU, the BUDI-DI (GMN) is assigned independent of packaging and labeling and is not used for supply chain identification or transactional purposes. BUDI-DI is a product family identifier, grouping one or more UDI-DI child identifiers. In a product family, individual products are identified by common characteristics or variants. Technical documentation, certificates and EU Declarations of Conformity require BUDI-DI. The UDI-DI (GTIN) identifies the product in the supply chain and in the UDI database, linked to only one Basic UDI-DI. These two identifiers are made independent of one another.
As you can see, medical Device registration and UDI submission with health authorities carries many nuances, particularly from region to region. Many health authorities are issuing regulations for UDI, requiring manufacturers to make their products globally identifiable, scannable by code and mandating product data be submitted to the health authority database. The timelines approach quickly and UDI team preparation is no easy task. Preparing early with a data strategy will make all the difference when mandates for EUDAMED and other health authorities come due.
Learn more about EUDAMED device registration, UDI submissions and BUDI-DI requirements from the industry experts at Reed Tech.
