Unique Device Identification (UDI) requirements will improve end to end global traceability for medical devices, but grey areas exist concerning how to operationalize a solution that encompasses a range of global variation and complexity. You may ask, why is a global solution needed now? As more medical device solutions are launched globally, a harmonized method for traceability throughout the supply chain that supports post-market safety activities and regulatory activities is crucial. It empowers organizations to focus on bringing medical devices to market with more predictability and to enhance post market activities.

The following four benefits outline why a single UDI system is needed, especially to remove redundancy, streamline product launches and support essential post-market activity:

Examining the four stages in the UDI system

1. Traceability

With a UDI number, products have robust sourcing and manufacturing information built in which assists with ensuring uniformity and regulatory data compliance. The UDI consists of the Device Identifier (DI) and Product Identifier (PI) with each playing an important role. The DI contains the regulatory information and appears as the permanent marketing on the device. On the other side, the PI assists with quality control and operations such as the serial number, manufacturing date and shelf life of the device.

The International Medical Device Regulators Forum (IMDRF) has different recommendations for different devices on what DI or PI must be on the packaging or device itself. Companies should become familiar with the requirements for the device being brought to market to understand what numbers and where it should be placed on the solution. Additionally, it is important to look how each country interprets technical formats on reporting these figures. There are some variations between the GS1 to HIBC to ICCBA Standards that all contains parts of the DI and PI figures. This is a grey area where further guidelines on how standard implementations that are truly global is needed to drive greater harmonization.

2. Global Operations

Each process in the lifecycle of the product will impact and change the UDI number. At this level, the UDI number is linked to the global supply chain, inventory and distribution, thus any product lifecycle management (PLM) change needs to be captured.

For instance, in design control, mandatory data in the regulatory databases are used to register devices in different countries. Production and logistics must use UDI requirements to determine how to package and generate labels for global compliance. Once a product is launched with a UDI number, the numbers are used to track post market activities including adverse event reporting, recalls and field safety corrective actions. Additionally, adopting UDI traceability assists with the change management process by trickling the changes across the product lifecycle. It allows for dynamic data management across multiple databases and faster facilitation of the said changes.

However, the problem is localization of the UDI systems and requirements. This implies the need for now developing and handling local UDI solutions in the product-inventory management systems. Additionally, some country purchasing bodies go beyond the requirement to have a UDI and state, for example as a tender requirement, the need to use a specific UDI solution. This can result in a company needing to decide whether it is commercially viable to meet the requirements of this purchasing body as running multiple UDI solutions (or developing a customer specific UDI solution) can add an extra layer of complexity and cost to an organisation. A strong regulatory intelligence team will be required to track the evolving requirements to this type of labeling and to additionally overlay the UDI requirement into one of many, global labelling requirements for medical devices.

3. Safety

A key goal of a global UDI is to increase patient safety and enhance the effectiveness of adverse event reporting and associated post market activity. In looking at PI numbers, this focuses on the production side with manufacturer and expiration dates. The DI number is related to the market approval and post launch information including clinical investigations, registrations, certifications and product vigilance. It allows for enhanced traceability and consistency as the UDI is the key to all the information. Having a global system allows for enhanced patient safety and the uncovering of trends faster. Incidents at global levels are traced and tracked which in turn could help drive better clinical decision making and patient safety.

4. Industry Impact

One large impact of a global UDI program would be the efficiencies in supply chain and clinical practices. It ensures consistent documentation through a connected database system, streamlines medical claims and reimbursements. It drives greater patient safety and treatment efficiency while also providing life science firms with greater cost savings. This impact for all areas of business demonstrates the need for a global UDI program.

In examining these four benefits of a centralized UDI system, a global, harmonized method is needed to drive forth a single standard for greater traceability and responsibility for MedTech Industry. UDI plays a direct role in the regulation process for products given that information used and tracked through the UDI system is needed for compliance submissions.

Most importantly UDI is the key that helps integrate multiple fragmented tracking systems across safety, regulatory and post market surveillance. It goes beyond just optimizing systems to pioneering the transformation of compliance from a requirement to a competitive advantage. It provides bi-directional trace and transparency by mapping product to process to documents to actual use. It simplifies global operations by integrating product trace in supply chain and hence the inventory management at the healthcare provider. This in turn adds to tremendous cost savings and better clinical outcomes.

For more details on UDI, watch the on-demand webinar, “UDI Requirements – The Fear Of The Unknown.” To speak with an IQVIA expert and learn more, send a note to RegulatoryTechnology@iqvia.com .