European Commission designates GS1 as issuing entity for Unique Device Identification (UDI)

The global standards body becomes an authorised issuer for identifying medical devices, and introduces a new identification key to support the process

On 7 June 2019, the European Commission designated GS1 as an issuing entity for Unique Device Identifiers (UDIs)

The UDI system intends to provide a globally harmonised framework for identification of medical devices, to enhance quality of care, patient safety and business processes. This will allow for devices to be unambiguously identified and tracked and traced, throughout the global healthcare supply chain.

According to European Union (EU) Regulations, a UDI number should be applied to the medical device label, its packaging, and/or the device itself, with required product data submitted to the European Database on Medical Devices (EUDAMED). 

In addition, EU regulations introduced a new identifier to classify a group of products – the Basic UDI-DI. To support the implementation of this requirement, GS1 has developed a new companion key, known as the Global Model Number (GMN).

Why now?

A recent investigation conducted by BBC’s Panorama programme, provided compelling reasoning behind the significance of this regulatory update. 

Working with 58 media organisations across the world, the programme makers found that some devices were failing patients. 

The lack of transparency and data collection made it difficult for regulatory bodies and healthcare professionals to identify and recall any affected medical devices, leaving a lack of clarity as to the full scale of the problem. The UDI system, underpinned by GS1 standards, sets out to combat such challenges.

Increased traceability throughout the supply chain will not only make it quicker and easier to manage medical device recalls, but also allow for more accurate reporting of adverse events, ultimately reducing medical errors. 

As a result, healthcare professionals working around the world will now have access to precise medical device information to support informed clinical decision making.

GS1 has already been accredited in the USA since 2013, as a designated UDI issuing agency. Now regulators across the world are also planning to use GS1 standards as the basis of their national UDI system.

Extending this across Europe will support EU regulators so they can ensure that the UDI system, as defined by the EU Medical Device and In-Vitro Diagnostic Medical Devices regulations, is implemented successfully. This will enable manufacturers to comply with these requirements that come into force in May 2020.

The fundamentals

GMN structure

To meet the new requirement released by the European Commission in November 2018, the length of the GMN structure has been reduced to a maximum of 25 characters and each GMN must now include the check-character(s)

The rationale is to avoid errors in the manual writing of the GMN in relevant documentation and in the EUDAMED system. You can find details on how to calculate the check-character(s) here.

What does this mean for medical device suppliers?

This means that all medical device suppliers need to follow the European Commission requirements to ensure all devices are compliant. 

How do I make sure I’m compliant?

Apply the GS1 GMN updated standard for regulated healthcare medical devices to any required products, every medical device will need to comply with the EU requirements that come into force in May 2020.

Further information 

For more information about UDI, visit the GS1 global UDI resource web page. There is also a brochure available for download on the basics behind UDI.

Details of the GMN structure can be found here.

There are also regular dedicated healthcare supplier training courses to help suppliers meet local legislation requirements. 

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