In an attempt to clarify, here’s an overview of key information regarding UDI management for medical devices. This article doesn’t claim to be a comprehensive guide, but it certainly lays the foundation for navigating the topic.
There are only 4 organizations recognized by the European Commission for issuing UDI codes for medical devices: GS1, HIBCC, ICCBBA, and IFA. All designated by Implementing Decision (EU) 2019/939.
Slightly different approaches, but the basic concept is the same for all.
Code Composition
The UDI code consists of 2 parts: UDI-DI and UDI-PI.
Regardless of how the two codes are structured – whose rules depend on the issuing body – it’s sufficient to know that the first part contains the unique identification code of the model (the product’s REF, the catalog code); the second may contain one or more of the following information: s/n, batch, software identifier, manufacturing date, expiration date. What to include in the UDI-PI is at the discretion of the company, except for implantable, reusable, configurable devices and software.
Regardless of the issuing body, registration is required through payment of a fee that allows obtaining a company prefix.
Basic UDI-DI
Finally, there’s a third code, called Basic UDI-DI, composed of the company prefix and a code defined by the manufacturer. The Basic UDI-DI represents multiple medical devices with the same intended use, class, design and manufacturing characteristics. In this case too, the issuance process is identical to what’s indicated above.
The Basic UDI-DI is the highest-level element that allows linking all the information of that device in Eudamed.
It must be obtained before placing the product on the market and, after the certificate is issued by the Notified Body (where required), registered in the UDI database which, to date, is not yet accessible.
Use and Application
The labeling of the medical device and its packaging must display the complete UDI code (UDI-DI and UDI-PI). For each production, the code must be generated, printed, and applied. The application of the code follows precise rules and does not replace other marking and labeling requirements.
The certificate issued by the Body, the free sale certificates, the EU declaration of conformity, only show the Basic UDI-DI.
A new UDI-DI must be generated in case of changes that may lead to incorrect device identification and/or ambiguity in traceability.
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