As medical technology becomes increasingly advanced, the demands for control, transparency, and patient safety continue to grow. An important step in this development is the introduction of
The introduction of the UDI regulation aims to create safer healthcare through reliable product data. This brings benefits for patients, healthcare providers, and manufacturers, says Staffan Olsson, Head of Public Affairs at GS1 Sweden.
Why UDI, and why now?
UDI is a global standard that makes it possible to assign each medical device a unique identity. It consists of two parts: a device identifier (UDI-DI) and a production identifier (UDI-PI), and can be applied as a barcode or a two-dimensional code (in this case, a GS1 DataMatrix) on the label, packaging, and in some cases directly on the product.
UDI is a central component of the EU’s new regulations, MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), which have been introduced to enhance patient safety, transparency, and traceability across Europe. All medical devices covered by the regulations must be labeled with a UDI and registered in the European database EUDAMED, creating a shared, central source of information for authorities and healthcare providers.
– UDI allows us to track a product from manufacturing to use with the patient. This creates security, reduces the risk of mistreatment, and enables faster and more accurate recalls if something goes wrong,” explains Staffan Olsson.
What do manufacturers need to do?
Implementing UDI involves a comprehensive effort that affects the entire company, from product development to IT systems and labeling.
A good starting point is to map out the product portfolio and determine which products are covered by the regulations, the order in which they should be registered, and how the labeling should be carried out.
The process of implementing UDI involves several steps, for example:
- Create and assign UDI – each medical device needs to be given a unique code through an authorized issuing agency, such as GS1 Sweden.
- Labeling – the code needs to be applied to the label, packaging, and in some cases directly on the product. A common challenge is adapting the labeling for small or sterile products, which requires technically robust solutions.
- Registration in the UDI database EUDAMED (Europe) or GUDID (USA) – all relevant product data must be registered and kept up to date.
- Procedures for traceability and quality – healthcare providers and manufacturers must be able to track the product throughout the entire supply chain.
– We recommend that companies plan early, establish clear procedures, and ensure data quality. In this way, UDI becomes not a hurdle, but a natural part of quality management, says Staffan Olsson.
From regulatory requirement to value creation
Although UDI is primarily introduced as a regulatory requirement, it can quickly become a strategic asset. When companies integrate UDI data into their systems, they gain full control over their products, enabling more efficient recalls, improved quality assurance, and the ability to analyze product usage and performance.
– UDI makes product information more accessible and reliable, which strengthens trust among both healthcare providers and patients, says Staffan Olsson, adding:
– By viewing UDI as part of healthcare digitalization, rather than as an administrative burden, manufacturers can create real business value. It’s about using data more intelligently, to benefit both the company and the patient.
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