Understanding Basic UDI and UDI: A Complete Guide for Manufacturers
Basic UDI and UDI Registration for EU Manufacturers
How The UDI System Works?
In accordance with the EU MDR and IVDR regulations, each manufacturer shall introduce Unique Device Identification (UDI) and submit product related information to EUDAMED, the database of medical devices of the EU. The UDI system contributes to increased traceability, transparency of medical devices on the market, and patient safety. This guide defines what UDI is, the relation between UDI and EUDAMED, and the actions required from manufacturers.
What Are The Key Elements Of UDI?
UDI = UDI-DI + UDI-PI
UDI-DI (Device Identifier): The static part which identifies the manufacturer and the particular model/version of the device.
UDI-PI (Production Identifier): The dynamic part that includes manufacturing information, i.e. batch/lot number, serial number, and/or production and expiration dates.
The above elements allow identifying any product through all the stages of distribution and usage.
What Is The Basic UDI-DI (BUDI-DI)?
In addition to the device-specific UDI, each product line should have a Basic UDI-DI an identifier that serves the administrative purposes within EUDAMED
Basic UDI DI: How It Works
Classifies products according to their purpose, risk class, and key design features.
Acts as a reference for certificates, declarations of conformity, and technical documentation
Does not go on labeling and packaging (internal regulatory reference only).
Connects all the related UDI-DIs.
Example: If you sell three variants of the glucose meter (Standard, Pro, Lite), then each variant has a separate UDI-DI but the same Basic UDI-DI.
What Information Is Needed For Basic UDI And UDI Registration?
During UDI registration in EUDAMED, the following pieces of information are required:
Basic Device Information
Basic UDI-DI: Top level identifier for a set of devices having the same intended purpose and classification.
Name of the device, model name, trade name, catalogue / reference numbers.
Intended purpose and classification according to risk.
UDI-DI and UDI-PI (if required).
Organization Information
Manufacturer and/or Authorized Representative in the EU.
Designing and manufacturing organization (in case they are different).
Documents & Classification
Detailed CE certification information (when the Notified Body is needed).
Device classification (Class I, IIa, IIb, III or A, B, C, D for IVD).
EMDN (European Medical Device Nomenclature).
Marketing information: places, where a device is marketed or intends to be marketed.
Device characteristics (sterile, latex, single-use, handling/storage conditions, warnings / contraindications etc. depending on device characteristics).
Clinical evaluation information (if required).
What Is The Legal Framework?
The implementation of UDI system is obligatory for:
Mandatory activation of EUDAMED (new update 2026)
According to Commission Decision (EU) 2025/2371, four major EUDAMED modules (Actor Registration, UDI/Device Registration, Notified Bodies & certificates, and Market Surveillance) are recognized as fully operational. Accordingly, following the phased approach outlined in Regulation (EU) 2024/1860, the use of these modules became obligatory as of May 28, 2026. Any alternate national or parallel systems became not applicable anymore.
Manufacturers have to:
Assign UDI-DI and (if applicable) UDI-PI before placing the device on the EU market.
Mark UDI on the label/packaging or directly on the device itself if it is reusable.
Register devices' data (including Basic UDI-DI and UDI-DI) in EUDAMED before placing the device on the market.
Perform updates in case of any changes affecting identification and traceability.
Special Cases
Regulations and guidance above aim to assure that all medical devices, including legacy devices, are correctly registered in EUDAMED in Europe.
Legacy Devices:
Legacy devices (marketed under previous Directives) may use temporary identifiers in the process of transition. According to Regulation (EU) 2024/1860 and Commission Decision (EU) 2025/2371, the manufacturer has to perform full EUDAMED registration of all legacy devices, which are still marketed or distributed till the last date – November 27, 2026.
Key Regulations & Guidance for Legacy Devices:
Regulation (EU) 2024/1860: Guidelines how to register legacy medical devices in EUDAMED.
MDCG 2021/25: Guidelines how MDR applies to pre-MDR devices.
MDCG 2022/8: Guidelines how IVDR applies to pre-IVDR devices.
Custom made devices:
Custom-made devices (CMDs) do not have to be registered in the EUDAMED Devices/UDI module. According to Article 29(4) of the MDR, it is only necessary to register devices in EUDAMED (excluding CMDs) prior to putting them on the market.
Highly Individualised Devices & Master UDI-DI:
Some highly individualised products utilise the Master UDI-DI approach to group the variants which share specific clinically relevant parameters in order to avoid a disproportionate number of data entries in EUDAMED.
Contact Lenses: Subject to the Commission Delegated Regulation (EU) 2023/2197 (as amended by Commission Delegated Regulation (EU) 2025/788). From 9th November 2026, the Master UDI-DI approach will be mandatory. More details can be found in MDCG 2024-14 Rev. 1 (August 2025).
Spectacles and Eyewear: From Commission Delegated Regulation (EU) 2025/1920, spectacle frames, spectacle lenses and ready-to-wear reading spectacles are subject to the mandatory Master UDI-DI approach from 1st November 2028. Detailed information can be found in MDCG 2025-8.
Maintaining Compliance
After registration, it’s necessary to:
Regularly review and update device information.
Make sure that all supporting documents and label samples correspond with the registered data.
Make sure that your Authorised Representative keeps valid registration and SRN.
Follow up any new MDCG guidance and European Commission notices.
Summary And Next Steps
Registration of devices according to the UDI/EUDAMED will help manufacturers comply with the EU regulation and gain easier market access.
Manufacturers should:
Map their Basic UDI-DI and Master UDI-DI scheme (if any).
Validate UDI codes issued by one of the authorised issuing agencies (GS1, ICCBBA, HIBCC, IFA).
Assign internal roles for UDI/EUDAMED data management.
Make sure that all data about their devices is up-to-date in EUDAMED in order to comply with the mandatory dates 2026 onwards.
Conclusion
The UDI system is one of the essential requirements under the MDR and IVDR. The UDI system improves traceability, safety and transparency of medical devices in the EU. Assigning unique identifiers and keeping up-to-date data in EUDAMED allows efficient market surveillance, quick recalls, anti-counterfeiting and safe use of devices.
How Morulaa Can Help?
Morulaa is a platform powered by artificial intelligence technology that will assist medical devices manufacturers with UDI code generation, EUDAMED registration and compliance with the requirements of EU MDR/IVDR.
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