Vetted consultants
How we vet consultants
Only firms that pass our review are listed here.
- We assess regulatory experience, service scope, and professional credentials.
- Approved status may be revoked if standards are not maintained.
February 13, 2026
Approximately 5 minutes
Reviewed by Nate Lam, Founder & Director, ElendiLabs
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
Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
Registered Pharmacist · AI Engineer · Director, ElendiLabs
Registered pharmacist, AI engineer, HKHAIS founder, and pharmaceutical & medical device SEO/GEO specialist.
Ask Anything
We'll follow up with you personally.
100% response rate • Reply within 7 business days
Related Articles
Approximately 5 minutes
Classification of Medical Devices and IVDs in Norway
Norway classifies medical devices per MDR Annex VIII into risk classes I–III based on intended purpose, invasiveness, duration and active nature; IVDs per IVDR Annex VIII into classes A–D; manufacturer responsibility with NoMA guidance and notified body verification for higher classes.
Approximately 5 minutes
Classification Rules for Medical Devices and IVDs in Norway
Norway classifies medical devices per MDR Annex VIII into risk classes I, IIa, IIb, III and IVDs per IVDR Annex VIII into classes A, B, C, D based on intended purpose, invasiveness, duration of use and active nature; manufacturer responsible for classification with NoMA guidance and notified body verification for higher classes.
Approximately 5 minutes
Quality Management System and Risk Management for Medical Devices in Norway
Norway requires manufacturers to establish a quality management system (ISO 13485) and risk management system (ISO 14971) from the development phase to ensure compliance with MDR/IVDR, covering design, production, post-market surveillance, and benefit-risk evaluation.
Approximately 5 minutes
Standards and Common Specifications for Medical Devices in Norway
Norway relies on harmonised European standards (CEN/CENELEC) and European Pharmacopoeia monographs for presumption of conformity with MDR/IVDR essential requirements; manufacturers may use other solutions but must document full compliance; NoMA references MDCG guidance for standardisation.
Approximately 5 minutes
Language Requirements and Information Supplied with Medical Devices in Norway
Norway mandates Norwegian language for labelling and instructions for use on medical devices to ensure safe and correct use by professionals and lay users, allows electronic instructions for use under specific conditions, requires implant cards in Norwegian for implantable devices, and permits strict case-by-case exemptions via application to NoMA.