EC Offers Technical Guidance on UDIs

Regulatory NewsRegulatory News | 04 December 2019 |  By 

The European Commission on Wednesday released eight documents related to the technical specifications for unique device identifiers (UDIs).

Four of the documents are related to Basic UDI-DI, which manufacturers can use to connect and identify devices with the same purpose, risk class, design and manufacturing characteristics, and which are required elements for the incoming device database, known as Eudamed. The four Basic UDI-DI documents are from GS1, HIBCC, ICCBBA and IFA.

The structure of the Basic UDI-DI is an 18-character data string, with various parts of that string signifying the manufacturing facility, the type of the product and the product description code, according to the ICCBBA guidance.

The other four documents, which are from the same four organizations, deal with UDI human readable interpretation (HRI) formats. HIBCC offers an example of three different UDI labels, including DataMatrix, linear concatenated and linear not concatenated. The information includes HRI qualifiers for UDI-DI, lot number, expiration date, serial number and manufacturing date.

The EC previously released two documents on what data from the UDI needs to be included in the Eudamed database, and another document on the Eudamed device data dictionary.

European Commission


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