Implementation of UDI Requirements with Modular and Flexible Technology
White Paper: Future-Proof Compliance: A Global Perspective on Unique Device Identification
Quick access to product information, improved recall management, enhanced protection against counterfeiting and grey 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 labelling 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 labelling companies. As such, it is a valuable source of information for international product manufacturers and labelling companies.
The fundamentals of the EU Unique Device Identification system
Aiming to adhere to UDI requirements and their enforcement dates, medical device companies go through the implementation phase, which involves updating packaging lines with new technology and integrating additional IT solutions. Following the EU MDR and IVDR, medical device manufacturers will be fully responsible for performing the following steps:
Assigning UDIs to individual products
With very few exceptions, any medical device placed on the market shall be assigned a Unique Device Identifier that consists of the following data:
- a Device Identifier (UDI-DI) with fixed information about the manufacturer and the device;
- a Production Identifier (UDI-PI) with variable production data, such as a serial number or a lot number, date of manufacture and expiry date.
However, UDI requirements do not obligate manufacturers to generate UDI-DI data, as they will receive it from one of the authorized issuing agencies - GS1, HIBCC, ICCBBA or IFA – which they can choose freely.
Placing the UDI code on a product and its packaging
The UDI code represents a machine-readable (AIDC) and human-readable (HRI) code. The AIDC stands for Automated Identification for Data Capture and can be a linear barcode or a DataMatrix etc. As specified by the UDI requirements, the UDI code shall be marked directly on the device in the case of reusable products, or placed on its label and all higher packaging levels.
Barcode print quality depends on a number of different factors related to the quality and storage conditions of the packaging materials. Although there are no specific UDI barcode verification requirements, GS1 requests adherence to ISO/IEC verification standards to ensure barcode readability by all supply chain stakeholders.
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
Serialisation of Medical Devices
While fundamental to any efficient medical device traceability system, serialisation is also a UDI requirement for active implantable devices, e.g. pacemakers, defibrillators, implantable glucose monitors. Serialisation 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 serialisation 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 serialisation. This approach will help them keep their production lines future-ready in case serialisation 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.