‘Unique Device Identifier’ (‘UDI’) is a series of numeric or alphanumeric characters which are created through internationally accepted device identification and coding standards that allows clear identification of specific devices on the market. UDI is supported by a database which provides users and regulators a quick access to the information about the coded device. The UDI system and the compliance requirements for all medical device industry stakeholders are described in several articles and annexes throughout the MDR and IVDR to improve patient safety through better traceability and transparency. UDI system tends to significantly enhance the effectiveness of the post-market safety-related activities for devices.
An UDI comprises of
- A UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information
- A UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable to the packaged devices
Most devices will be required to have a UDI on their label and packaging, and for certain devices, on the product itself. Device companies must submit information about the devices to the GUDID (pronounced "Good ID").
The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). In collaboration with the National Library of Medicine, the FDA has created a portal, called AccessGUDID, to make device identification information in the GUDID available for everyone including patients, caregivers, health care providers, hospitals, and industry. FDA’s experience and feedback from industry indicate that device labelers often take a number of actions related to organizing, collecting and validating data before they get a GUDID account or submit device identifier (DI) records. Importantly, labelers may house necessary information in multiple systems and locations, making internal system coordination a key aspect of preparing data for the GUDID. We strongly encourage labelers to take the following steps to ensure their readiness to meet UDI requirements and streamline the GUDID submission process:
- Review UDI guidance documents to create an internal action plan/timetable for preparing data for the GUDID
- Work with FDA-accredited issuing agencies to assign and maintain UDIs. Establish processes for physical labeling
- Establish standard operating procedures for records management
- Gather data required for GUDID DI records based on the GUDID Data Elements Reference Table
- Understand the GUDID account structure and user roles as shown in the GUDID Guidance
- Identify individuals for the GUDID user roles and ensure that they understand GUDID functionality and responsibility for their user roles
- Identify/obtain appropriate Dun and Bradstreet (DUNS) numbers
- If your company has a DUNS number(s), verify that the information in the D&B database is correct and update any information if necessary
- If your company does not have a DUNS number(s), you can obtain one free of charge from D&B. Please note that this may take up to 30 business days; please plan accordingly
- Expedited options to obtain a DUNS number are available for a nominal fee
- Determine a GUDID submission option (GUDID Web Interface vs. HL7 SPL submission).
- If choosing HL7 SPL submission, establish a FDA ESG account and complete required testing.
- If needed, select a third-party submitter. For information on third-party submission, please refer to the GUDID Guidance
- Subscribe to the UDI mailing list to be notified about updates for the UDI program
- Subscribe to the GUDID mailing list to be alerted to database changes and GUDID system status updates
- Improve incident reporting
- Reduces recalls
- Reduces medical errors
- Fights against falsified devices
- Improves purchasing and waste disposal policies
- Improves stock-management by health institutions and other economic operators
UDI Future Outlook
Market entry for Medical Devices and date of application
- For implantable devices and for class III devices shall apply from May 26, 2021
- For class IIa and class IIb devices shall apply from May 26, 2023
- For class I devices shall apply from May 26, 2025
In Vitro Diagnostics entry into force and date of application
- For class D devices: shall apply from May 26, 2023
- For class B and class C devices shall apply from May 26, 2025
- For class A devices shall apply from May 26, 2027
The UDI shall apply to all devices placed on the market. So, how can we be compliant on time? It’s a good practice to initiate it by analyzing the internal processes in the organization. Assess the gap and plan to adjust the procedures to include UDI labeling, data submission and information tracking requirements.
To know more about UDI, Freyr’s in-house experts can help you understand various processes and pre- requisites in depth. Reach out to firstname.lastname@example.org.