Identification and traceability in the EU-MDR

What is a UDI and why is it important?

A UDI code for medical devices is a unique identifier to be generated according to the rules of an issuer designated by the European Commission. The code consists of a Device Identifier (DI) and a Production Identifier (PI) and contributes to:

• Improved patient safety through faster recalls of defective products.
• Improved traceability of medical devices within the supply chain.
• Higher transparency in the medical device market.

Regulatory updates for 2025

The European Commission has further extended the implementation of the EUDAMED registration system, and it will be fully operational from 2025. This means manufacturers must not only generate a UDI, but also register it in EUDAMED. Additional guidelines have also been published on UDI marking on software and the application of UDI for reusable medical devices.

Who are the designated UDI issuers?

The European Commission has designated four bodies responsible for issuing UDI codes in Decision (EU) 2019/939:

1. GS1 AISBL – a global non-profit organisation that develops standards for product identification.
2. Health Industry Business Communications Council (HIBCC) – an international organisation focused on developing identification standards for the healthcare sector.
3. ICCBBA – responsible for the ISBT 128 standard, particularly applied in the blood and transplant sector.
4. Informationsstelle für Arzneispezialitäten (IFA GmbH) – a German organisation focused on the identification of pharmaceutical products.

Of these four bodies, IFA GmbH is the only one based in Europe. The other three already have experience with the UDI system as implemented by the US FDA.

A closer look at the four UDI issuers

1. GS1 AISBL

GS1 is an international organisation that focuses on standardisation within various sectors. GS1 has developed a Global Model Number (GMN) to meet the EU’s new Basic UDI-DI requirements. They also provide tools, such as a GMN verification calculator, to support manufacturers in correct UDI assignment.

2. Health Industry Business Communications Council (HIBCC)

HIBCC develops standards specifically for the healthcare industry. Before a manufacturer can create a UDI through HIBCC, a Label Identification Code (LIC) must first be requested. The cost for this LIC depends on the company’s annual turnover, with a one-off fee of up to $2,500 for companies with turnover of up to $10 million.

3. ICCBBA

ICCBBA manages the ISBT 128 standard, which is used for the identification of blood products and transplants. Currently, ICCBBA has no explicit information on their compliance with EU MDR requirements.

4. Informationsstelle für Arzneispezialitäten (IFA GmbH)

IFA GmbH focuses on pharmaceutical identification and offers the Pharmacy Product Number (PPN) as a compliant UDI-DI. For manufacturers wishing to use the PPN as UDI-DI, a contract with IFA is required.

What does this mean for manufacturers?

For medical device manufacturers, it is essential to choose an appropriate UDI issuer and ensure that their products comply with MDR and IVDR regulations.

Check the specific UDI requirements within the EU and compare them with the US FDA guidelines.
Register with a designated issuer and follow proper procedures for obtaining a UDI.
Take into account regulatory updates, such as mandatory registration of UDIs in EUDAMED and new guidelines for software-based UDI marking

Conclusion

The implementation of UDI regulations in 2025 is a key sstep towards a safer and more transparent medical ecosystem. By working with one of the four designated UDI issuing entitities, manufacturers can comply with European regulations and contribute to the safety and traceability of medical devices. Make sure you keep abreast of the latest developments and implement the UDI system correctly within your organisation!

Download the UDI checklist here