GTIN
Colloquially, many know GTIN as a barcode, but technically, GTIN is the number found beneath the barcode symbol itself, and can therefore also be used for other technologies such as 2D barcodes and RFID tags.
Colloquially, many know GTIN as a barcode, but technically, GTIN is the number found beneath the barcode symbol itself, and can therefore also be used for other technologies such as 2D barcodes and RFID tags.
Danish manufacturers of medical devices are increasingly required to comply with a range of regulatory requirements regarding labelling and the exchange of master data.
We help you understand GS1 standards and advise you on how to use a GS1ID to create a UDI and Basic UDI-DI for your medical device products. In addition, we have developed GS1 UDI Link, which you can use to submit master data to regulatory databases.
Regions, medico-manufacturers and GS1 Denmark have agreed on a common Danish data model for medical devices. Now the next step is to adopt the model and start exchanging master data digitally via GDSN.
The goal is to do away with manual exchanges in Excel and PDF and instead share structured product data directly between suppliers and regions. It provides a common data base, higher data quality and less manual work throughout the value chain.
At GS1 Denmark we help you get started. Our healthcare team advises both suppliers and regions on the data model, the GDSN and the practical steps towards automatic data sharing.
See how to get started with sharing product data
I
Are you ready for the requirement to register medical devices in the European database EUDAMED from 28 May 2026?
With our UDI connector, GS1 UDI Link, you can save time and resources by automating your reporting through data sharing via GS1Trade Sync.
The connector can also help you submit data to GUDID and other medical device registries.
Do you manufacture medical devices under the MDR or IVDR? Then your product must have a UDI. The requirement for when your UDI must appear in barcode form depends on the device’s risk class.
Here is a brief overview of the key deadlines for implementing Unique Device Identification (UDI) in accordance with the EU regulations.
Need help on how to form your UDI and get it encoded in a barcode? Then we are ready to help and offer a free course.
When products arrive at a hospital, it is essential that they can be identified. The GS1 barcode provides the product with a globally unique identification—an identification that is crucial for the supply chain, traceability, and patient safety.
Watch this short e-learning animation about a patient pathway and the importance of product identification, and see how the barcode is used for improved inventory management, increased traceability, and fast recalls.
On 26 May 2021, the EU Medical Device Regulation entered into force, introducing new requirements for manufacturers.
One of these requirements is that medical devices must have a UDI (Unique Device Identification). The UDI is used to uniquely identify medical devices and ensure traceability throughout the supply chain.A UDI consists of the product’s Device Identifier (DI) and its Production Identifiers (PI).
You create your UDI-DI using a GS1ID, which you can purchase via My GS1.
The EU Medical Device Regulation requires that medical devices have a Basic UDI-DI.The Basic UDI-DI does not identify a single specific product, but rather a group of products with the same essential characteristics.It must be registered in the EU’s medical device database, EUDAMED, and appear on relevant certificates and in the EU Declaration of Conformity.
You create your Basic UDI-DI using a GS1ID, which you can purchase via My GS1.
If you sell medical devices in the EU or the USA, you must submit the product’s master data to the EU’s medical device database, EUDAMED, or the U.S. database, GUDID.
For both databases, you are required to provide data such as the product’s UDI-DI, quantity per package, product description, and whether the product has a serial number.If you have many products to register, this can be a time-consuming and complex process. GS1 can help ensure efficient submission. The products’ master data is registered in GS1Trade Sync and transmitted electronically via our solution, GS1 UDI Link.
Do you manage your product data manually? Then you know how time-consuming it is to provide a separate sheet or form - often containing much of the same information - to each individual recipient. You are also familiar with the risk of data errors and missing information when making updates and following up to ensure that recipients have received and are using the latest data.
If you use GS1Trade Sync instead - our Danish system for data exchange via GDSN - you only need to enter your data in one place and can efficiently exchange and maintain it. This ensures that all your recipients always have access to the latest and most reliable product data - while saving you time. Read more about GDSN
At GS1 Denmark, we focus on making cross-border data exchange as simple as possible. We therefore collaborate with several EU countries to harmonise data requirements across borders and standardise the way data is exchanged within the EU.
A common dataset, named ECHO, will make the process easier for both manufacturers and hospitals by aligning medical device product data across all participating countries.
If, as a supplier, you already provide data to your Danish customers via GS1Trade Sync, GS1 Denmark’s GDSN data pool, you will be able to easily exchange the same data with other EU countries - saving both time and resources.
GS1 Webinars
We regularly offer courses and webinars on our standards and services relevant to medical device manufacturers.
If you have questions about how to use our GS1 standards, you can receive help and guidance every day.
We are ready to guide you smoothly through the process.
