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‘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.
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:
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.