Vejledninger
12. marts 2026View transcript
If there is a problem with a medical device, questions quickly arise. Who? What? Where? When? Why? Then it is important to get reliable answers quickly. This is why there are regulations for unique device identification, abbreviated to UDI. These regulations require medical device manufacturers to make their products globally identifiable, make them scannable and include the product data in a UDI regulatory database. UDI already exists in the United States and in the European Union, but with one difference. The European UDI regulations also require a basic UDI-DI. The basic UDI-DI is the highest level of identification of the product hierarchy within the OIDEMED database and identifies an entire product family or a product model. In a product family, individual products are combined in different variants and with common characteristics. Each product has its own unique number, the UDI-DI. Not to forget, a UDI-DI must always be linked to only one basic UDI-DI. One more important remark. The basic UDI-DI is not only required to access the OIDEMED database, it must also be included in all relevant documents for the products. For example, certificates, EU declarations of conformity and technical documentation. Now let's see how you can build the basic UDI-DI with GS1 standards. The GS1 global model number, abbreviated GMN, is a GS1 key which allows the creation of a basic UDI-DI. The first part is the GS1 company prefix, which is uniquely assigned to a GS1 member company. The manufacturer internal number for that group of devices follows, which is assigned directly by the manufacturer. At the end of the GMN, there are two check characters, which can be generated using the GMN calculator. And the global model number, that is the basic UDI-DI, which can be up to 25 characters long, is ready. Important note, the basic UDI-DI does not appear in text form or in a barcode on the products or product packaging. This means that it has never been encoded in a barcode, but is used in the OIDEMED database and in relevant documents. We hope to have answered most of your questions on the GMN. More information? Go to gs1.org Do you have questions about the implementation? Contact one of our 114 GS1 member organisations around the world. On theиль-PI we keep online.
