Implementation of UDI Requirements with Modular and Flexible Technology
WHITE PAPER: ACHIEVING UDI COMPLIANCE FROM A GLOBAL PERSPECTIVE
Quick access to product information, improved recall management, enhanced protection against counterfeiting and gray markets – Unique Device Identification (UDI) of medical devices is expected to revolutionize the medical device industry. At the same time, it poses multiple questions and creates various concerns for product manufacturers and labeling companies. It is important not to lose sight of the global perspective, which involves keeping all UDI-related developments and changes in mind.
Find out about UDI implementation challenges and success factors from a global perspective in this white paper. The document offers a global overview of the latest developments in the international arena for product manufacturers and labeling companies. As such, it is a valuable source of information for international product manufacturers and labeling companies.
The Fundamentals of the EU Unique Device Identification System
Registering and updating UDI data in EUDAMED
EUDAMED, an updated interoperable European database for collecting, renewing and exchanging medical device information, will serve as an access point for regulatory bodies, economic operators, health care providers and the public.
Adhering to the UDI compliance timeline
The UDI implementation deadlines differ based on the classification of medical and in-vitro diagnostics devices into three different categories corresponding to their risk levels. Additionally, the timeframe depends on whether the manufacturer places the UDI code on the device itself or its label.
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UDI Requirements from the Global Perspective
Serialization of Medical Devices
While fundamental to any efficient medical device traceability system, serialization is also a UDI requirement for active implantable devices, e.g. pacemakers, defibrillators, implantable glucose monitors. Serialization refers to assigning a unique serial number to each finished product so that it can be automatically identified at the point of sale. The pharmaceutical industry is already deploying serialization as an anti-counterfeit measure on the global level, and this technology is gaining momentum in other sectors as well. Even companies whose products do not fall under the category of active implantable devices will benefit from equipping their lines with flexible technology that enables both UDI compliance and serialization. This approach will help them keep their production lines future-ready in case serialization becomes an imperative UDI requirement for more product groups, or is mandated in certain importing countries.
Aggregation of Medical Devices
Although not mandated by UDI requirements, aggregation of medical devices is another pillar of optimal medical device traceability. Aggregation refers to creating a parent-child hierarchy between different levels of product packaging, starting from a product unit up to a pallet. For example, to aggregate several product units into a shipping case, the following steps are undertaken:
- A UDI barcode for each product is scanned;
- The barcode data is aggregated and linked to the shipping case;
- The shipping case receives its label with a UDI barcode including a unique serial number.
This process can be repeated for all packaging levels. When scanning a code, the operator receives all UDI information related to the medical devices contained in the shipping case.