Medical device identification (UDI)
Compliance with European regulations on the identification of medical devices and in vitro diagnostic devices through the Unique Device Identifier (UDI).
Get the GS1 licencePrepare your medical devices for European compliance
The identification of medical devices and those of in vitro diagnostics and that of and is strictly regulated in the European Union by two major legislative acts that came into force on 25 May 2017: Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
The GS1 organisation is officially accredited by the European Commission to issue and manage the codes within the UDI (Unique Device Identification) system. GS1 Romania provides manufacturers with the technical infrastructure, based on global standards, that supports them in the regulatory compliance process.
UDI is not just a compliance requirement
It is the foundation of the identification and traceability of medical devices throughout the product's life cycle.
Access to the European market
UDI is an integral part of the MDR and IVDR requirements for placing medical devices on the market in the European Union.
Full traceability
Enables rapid identification of devices, batches and series at any time. Through the hierarchical identification system, from model (Basic-UDI), to device (UDI-DI), down to batch or even unit (UDI-PI)
Patient safety
Reducing medical errors and combating counterfeit products through real-time access to accurate information, straight from the source.
Risk reduction
Devices in higher risk classes can be tracked at unit level and monitored throughout their use.
Everything you need to implement UDI
Internationally recognised identifiers
Obtain the identifiers required for medical devices and their packaging.
Standards used worldwide
GS1 is one of the recognised issuing organisations for the UDI system in the European Union and in other major jurisdictions.
Compatibility with EUDAMED
GS1 identifiers can be used for the applicable registration and compliance processes.
Support for traceability
The same standards are used in production, distribution and supply chain management.
Identifiers and standards ready for implementation
Basic UDI-DI
The model identifier (GMN), used as the Basic UDI-DI, is the primary access key to the EUDAMED database and identifies a family of devices with similar characteristics. It does not appear on the label but only in the technical documentation or the declaration of conformity
Device identification
The item code (GTIN), the equivalent of the UDI-DI, is the static code specific to a particular device model or a specific configuration within a range. It serves as the access key to the public information in the database.
Dynamic identification
The UDI-PI is the dynamic segment of the identifier and contains the production data specific to each unit. It includes the batch number, serial number, manufacturing date or expiry date, entered into the code structure using GS1 application identifiers
UDI marking on the label
The regulations require that the physical carrier of the UDI code be placed directly on the device label and on all higher levels of packaging, both in an automatically readable format (1D barcode or two-dimensional QR/DataMatrix) and in plain text, placed below or next to the barcode.
The global standard for healthcare
- International recognition
- Used in over 100 countries
- Compatibility with global healthcare ecosystems
- Standards used by millions of organisations
- Support for traceability and digitalisation
Companies involved in the medical device market
- Medical device manufacturers
- Manufacturers of in vitro diagnostic devices
- Authorised representatives
- Importers and distributors
- Companies preparing to register products in the EU
Start implementing UDI
Get the GS1 identifiers you need for compliance, traceability and access to the European market.
Get a GS1 licence for UDI