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The Implementing Act has been officially published in the Official Journal as of 27 November 2025
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Important Deadlines for Medical Device Manufacturers:
The following EUDAMED modules are now active:
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16 Oct 2025 Updates to UDI/Devices (EUDAMED v2.18.0, 2025)
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The 16 October 2025 EUDAMED v2.18.0 (2025) release introduces targeted improvements to the UDI/Devices Module that strengthen how manufacturers manage and synchronize their UDI data within EUDAMED.
Key updates include:
1. New notifications for Authorized Representatives — ARs now receive alerts when a Basic UDI-DI linked to them is submitted or registered. This ensures real-time oversight and accountability in multi-actor workflows.
2. Terminology harmonization — Consistent labeling of Clinical Investigation/Performance Study terms across the module improves clarity and reduces confusion during device submission.
3. Improved data visibility — Fixed issues where related devices and legacy device details were not appearing correctly in search and view functions.. Known issue: Approval notifications for VAT/EORI/NTR updates require manual checking.
4. Public site accuracy — Resolved display errors for related legacy devices, strengthening public traceability.
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HOW DOES THE UDI SYSTEM WORK?
Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), every manufacturer must implement Unique Device Identification (UDI) and register product data in EUDAMED, the EU medical device database. The UDI framework improves device traceability, market transparency, and patient safety across the EU. This guide explains what UDI is, how it links to EUDAMED, and the steps manufacturers must take to comply.
WHAT ARE THE MAIN UDI COMPONENTS?
UDI = UDI-DI + UDI-PI
- UDI-DI (Device Identifier): The fixed element that uniquely identifies the manufacturer and the specific device model or version.
- UDI-PI (Production Identifier): The variable element that carries manufacturing details such as batch/lot, serial number, and/or production and expiry dates.
Together, these elements ensure each product can be uniquely identified at every stage of distribution and use.
WHAT IS THE BASIC UDI-DI (BUDI-DI)?
Beyond the device-level UDI, each product family requires a Basic UDI-DI, a higher-level identifier used for regulatory and administrative purposes in EUDAMED.
How Basic UDI-DI works
- Groups devices with the same intended purpose, risk class, and essential design features
- Serves as the reference key for certificates, declarations of conformity, and technical documentation
- Does not appear on labels or packaging (it’s an internal regulatory reference)
- Links all related UDI-DIs within a product family
Example:
If you market three versions of a glucose monitor (Standard, Pro, Lite), each version has its own UDI-DI, but all three share one Basic UDI-DI.
WHAT INFORMATION IS NEEDED FOR BASIC UDI AND UDI REGISTRATION?
When registering a device, EUDAMED requires the following:
Basic Device Information
- Basic UDI-DI: The top-level identifier for a group of devices with the same intended purpose and classification
- Device name, model, trade name, catalogue/reference numbers
- Intended purpose and risk class
- UDI-DI and UDI-PI (if applicable)
Organizational Details
- Manufacturer and/or EU Authorized Representative
- Design and manufacturing company (if different)
Documentation & Classification
- CE certificate details (if a Notified Body is required)
- Device classification (e.g., Class I, IIa, IIb, III; or A, B, C, D for IVDs)
- EMDN code (European Medical Device Nomenclature)
- Marketing information: where the device is available or intended to be sold
- Device characteristics (e.g., sterile, latex, single-use, storage/handling conditions, warnings/contraindications, as applicable)
- Relevant clinical evaluation information (if applicable)
WHAT IS THE LEGAL FRAMEWORK?
The UDI system is mandatory under:
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
Manufacturers must:
- Assign a UDI-DI and (where applicable) UDI-PI before placing devices on the EU market
- Mark the UDI on the label/packaging or directly on reusable devices
- Register device data (including Basic UDI-DI and UDI-DI) in EUDAMED
- Update registrations whenever changes affect traceability or identification
SPECIAL CASES
The purpose of these regulations and guidelines is to ensure that all medical devices, including older (legacy) devices, are properly identified and tracked within the European Union’s EUDAMED database are
Legacy devices : Â (placed on the market under previous directives) can use temporary identifiers until full UDI implementation.
Key Regulations for Legacy Devices
Regulation (EU) 2024/1860 : This rule explains how manufacturers should register older medical devices (legacy devices) in EUDAMED, the EU’s device database. This helps ensure all devices are properly tracked and meet safety standards.
Helpful Guidance Documents:
- MDCG 2021/25: This explains how the MDR (Medical Device Regulation) applies to devices that were on the market before May 2021.
- MDCG 2022/8: This document focuses on IVDR (In Vitro Diagnostic Regulation) for devices that were sold before May 2022.
Custom-made devicesÂ
Custom-made devices (CMDs) do not need to be registered in the EUDAMED Devices/UDI module. As per Article 29(4) of the MDR, manufacturers are only required to register devices in EUDAMED, excluding custom-made devices, before placing them on the market. Therefore, CMDs are exempt from this full registration process.
Certain product types (e.g., lenses) may use a Master UDI-DI approach when individual identification is impractical. Under the MDCG 2024-14 – rev.1 Guidance on the implementation of the Master UDI-DI solution for contact lenses.
MAINTAINING COMPLIANCE
After registration, it’s important to:
- Review and update device information regularly
- Keep supporting documents and label samples aligned with registered data
- Ensure your Authorized Representative maintains a valid registration
- Track new MDCG guidance and European Commission notices
SUMMARY AND NEXT STEPS
Registering devices under the UDI/EUDAMED framework supports EU compliance and smoother market access.
Manufacturers should:
- Map their Basic UDI-DI structure
- Validate UDI codes from approved issuing agencies (GS1, ICCBBA, HIBCC, IFA)
- Assign clear internal roles for UDI/EUDAMED data management
- Keep all device data current within EUDAMED
CONCLUSION
The UDI system is a central MDR/IVDR requirement that strengthens traceability, safety, and transparency for medical devices across the EU. By assigning unique identifiers and maintaining accurate EUDAMED records, manufacturers support effective market surveillance, enable efficient recalls, reduce counterfeiting, and enhance safe device use.
HOW WE CAN HELP
At Morulaa, helps medical device manufacturers streamline UDI code generation, EUDAMED registration, and regulatory compliance. It automates tasks like generating UDI-DI and UDI-PI codes, managing device data, and ensuring adherence to EU MDR/IVDR regulations. Morulaa also tracks regulatory updates, integrates with global standards, and provides reporting tools, making it easier for manufacturers to maintain compliance and improve efficiency.