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February 13, 2026
Approximately 5 minutes
Unique Device Identification (UDI) System for Medical Devices in Norway
Unique Device Identification (UDI) System for Medical Devices in Norway
1. Definition and Purpose
The Unique Device Identification (UDI) is a unique numerical or alphanumeric code associated with a medical device. It enables clear and unambiguous identification of specific devices in the market and facilitates their traceability. UDI consists of the Device Identifier (UDI-DI) and the Production Identifier (UDI-PI). The system enhances device tracking, simplifies recalls, combats counterfeiting, and improves patient safety. UDI is an addition to, not a replacement for, existing labeling requirements. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/unique-device--identification-udi-system
2. Scope and Applicability
The UDI system applies to all medical devices placed on the market in Norway, with exceptions for custom-made devices and devices intended for performance studies or clinical investigations. Norway implements the UDI requirements of MDR and IVDR directly through the EEA Agreement. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/unique-device--identification-udi-system
3. Manufacturer Responsibilities
Manufacturers must assign UDI to their devices, ensure proper labeling, and fulfill related obligations for registration in EUDAMED. The Norwegian Medicines Agency (NoMA) oversees compliance. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/unique-device--identification-udi-system
4. Labeling Requirements
UDI must be included on the device labeling where required by the regulations. The information must support safe and correct use. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/unique-device--identification-udi-system
5. Contact for Further Guidance
For more information or specific guidance, contact the Norwegian Medical Products Agency (NoMA) Medical Devices Unit at +47 22 89 77 00 or meddev-no@noma.no. Source: https://www.dmp.no/en/medical-devices/development-and-manufacturing/documentation-and-quality-management-system/unique-device--identification-udi-system
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