Purpose and Scope of This FAQ
This FAQ is designed for medical device and IVD manufacturers, regulatory affairs teams, UDI teams, and other stakeholders responsible for EUDAMED device registration and compliance. It provides practical guidance for organizations preparing, submitting, and maintaining device information in EUDAMED.
This FAQ focuses on EUDAMED actor and UDI/device registration, including timelines, manufacturer responsibilities, UDI requirements, legacy devices, data submission, and record maintenance. It does not provide comprehensive guidance on MDR/IVDR conformity assessment, clinical requirements, labeling, or other regulatory obligations.
Understanding EUDAMED
EUDAMED is the European Database on Medical Devices established under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). It is designed to provide a centralized source of regulatory information covering medical devices, IVDs, economic operators, certificates, market surveillance, and other regulatory activities throughout the device lifecycle.
EUDAMED was established to improve:
- Device identification and traceability
- Transparency of medical device information
- Access to information for healthcare professionals and the public
- Coordination between EU Member States
- Regulatory oversight throughout the device lifecycle.
For industry, EUDAMED also provides a centralized European system that reduces the need for separate device registrations across multiple EU Member States.
EUDAMED consists of six interconnected modules:
- Actor Registration
- UDI/Device Registration
- Notified Bodies and Certificates
- Clinical Investigations and Performance Studies
- Vigilance and Post-Market Surveillance
- Market Surveillance
EUDAMED also includes a public website through which applicable regulatory information can be accessed.
As of May 28, 2026, four modules are mandatory:
- Actor Registration
- UDI/Device Registration
- Notified Bodies and Certificates
- Market Surveillance
This followed the European Commission’s formal declaration in November 2025 that these modules were functional and met the required functional specifications.
The Clinical Investigations and Performance Studies module and Vigilance and Post-Market Surveillance module are not yet mandatory and will follow separate implementation timelines.
Yes. EUDAMED includes both restricted and public areas. Economic operators use the restricted environment to perform regulatory activities such as maintaining actor and device information. Applicable information is also made available through the EUDAMED public website, supporting greater transparency for healthcare professionals, patients, regulators, and other stakeholders.
Key Takeaway
EUDAMED is no longer a voluntary future requirement. Four modules, including Actor Registration and UDI/Device Registration, have been mandatory since May 28, 2026, making EUDAMED part of manufacturers’ ongoing MDR and IVDR compliance processes.
Device Registration Requirements and Timelines
The EUDAMED UDI/Devices module became mandatory on May 28, 2026. Manufacturers must now use the module to register applicable MDR and IVDR devices placed on the EU market.
Yes. For an applicable MDR or IVDR device whose first unit is placed on the market on or after May 28, 2026, the manufacturer must register the device in EUDAMED before placing it on the EU market.
November 28, 2026 is an important transitional deadline for device registration.
Where a Regulation device or applicable legacy device was already placed on the EU market before May 28, 2026 and additional units of that device continue to be placed on the market after May 28, 2026, the required device registration must generally be completed by November 28, 2026.
Not necessarily.
If a device was placed on the market before May 28, 2026 and no additional units are placed on the market after that date, the general transitional EUDAMED device-registration requirement does not apply solely because historical units remain in the supply chain. Other EUDAMED requirements can still apply in specific circumstances, such as where a device becomes subject to vigilance activities.
Yes.
Persons responsible for systems and procedure packs (SPPs) subject to Article 22 of the MDR must register the applicable systems or procedure packs in EUDAMED. Where Article 22(4) applies, the responsible person assumes manufacturer obligations and must register accordingly.
Key Takeaway
May 28, 2026 is the dividing line for mandatory EUDAMED use. New applicable devices must be registered before being placed on the market, while certain devices already on the market have a transitional registration deadline of November 28, 2026.
Manufacturer and Other Economic Operator Responsibilities
Economic operators subject to actor-registration requirements include:
- Manufacturers
- Authorized Representatives
- Importers
- System and procedure pack producers where applicable.
Actor Registration became mandatory on May 28, 2026.
SRN stands for Single Registration Number.
It is the unique identifier issued to applicable economic operators following validation of their actor registration by the responsible national competent authority. The SRN is used to identify the economic operator consistently across EUDAMED and applicable regulatory documentation.
Manufacturers subject to actor-registration requirements need to complete the applicable Actor Registration process and obtain the necessary EUDAMED access before performing device-registration activities. Establishing the correct actor account and user permissions should therefore be an early step in EUDAMED implementation.
Yes.
Manufacturers established outside the EU that place devices on the EU market must meet the applicable EUDAMED actor and device-registration requirements.
Their relationship with an EU Authorized Representative is an important part of the actor-registration process.
For manufacturers established outside the EU, the Authorized Representative is a key economic operator under the MDR and IVDR. The manufacturer-Authorized Representative relationship is represented within EUDAMED, and the Authorized Representative verifies applicable registration information associated with the manufacturer’s actor-registration request.
The manufacturer is responsible for ensuring that applicable device information is correctly submitted to EUDAMED.
For systems and procedure packs, the applicable system or procedure pack producer is responsible for registration. Using a third-party technology provider or regulatory service provider to facilitate submissions does not transfer the manufacturer’s underlying regulatory responsibility.
Importers have their own Actor Registration obligations but do not take over the manufacturer’s responsibility for registering UDI/device information. The manufacturer remains responsible for ensuring applicable device data is registered in the UDI/Devices module.
Key Takeaway
EUDAMED device compliance starts with establishing the correct economic operator registration, SRN, Authorized Representative relationships, and user access. Manufacturers remain accountable for the accuracy and completeness of their device registrations.
UDI and Device Data Requirements
A Unique Device Identifier (UDI) is a globally unique identifier assigned to a medical device.
It consists of:
- UDI-DI: The Device Identifier, which identifies a specific device and manufacturer.
- UDI-PI: The Production Identifier, which identifies production-related information such as lot, serial number, manufacturing date, or expiration date where applicable.
The Basic UDI-DI is the primary identifier of a device model or device family within the EU regulatory framework.
Unlike the UDI-DI, it does not appear on the device label. It connects devices with the same intended purpose, risk class, and essential design and manufacturing characteristics and serves as an important key connecting information across EUDAMED and regulatory documentation.
The Basic UDI-DI is used as a key reference across regulatory information including:
- EUDAMED
- Certificates
- EU Declarations of Conformity
- Technical documentation
- Summary of Safety and Clinical Performance, where applicable.
This makes accurate Basic UDI-DI governance important beyond the EUDAMED submission itself.
The manufacturer is responsible for assigning applicable UDI identifiers according to the rules of an EU-designated issuing entity. The manufacturer must assign a UDI to the device and applicable higher levels of packaging before placing the device on the market.
The four currently designated issuing entities are:
- GS1
- HIBCC
- ICCBBA
- IFA GmbH
Their designations were renewed in 2024 for an additional five-year period through June 27, 2029.
Manufacturers must provide the applicable UDI and device information specified under MDR or IVDR Annex VI, Part B.
Depending on the device, this includes information such as:
- Basic UDI-DI
- UDI-DI
- Manufacturer information
- Device name and model
- Risk class
- Nomenclature
- Device characteristics
- Packaging information
- Market status
- Applicable certificates and regulatory information.
The exact dataset depends on whether the product is an MDR device, IVDR device, legacy device, or another applicable device type.
UDI-PIs representing individual production values such as the actual serial number or lot number of every manufactured device are not registered as individual EUDAMED device records. Instead, EUDAMED captures applicable information about the types of production identifiers associated with the device.
Yes, where applicable.
Manufacturers must assign UDI-DIs to applicable higher levels of packaging in accordance with MDR/IVDR and issuing-entity requirements. Shipping containers are not considered higher levels of packaging for this purpose.
Key Takeaway
EUDAMED registration requires structured regulatory device data, not simply a UDI-DI. Manufacturers need reliable governance of Basic UDI-DIs, UDI-DIs, packaging hierarchies, device attributes, and related regulatory information.
Legacy Device Registration
Legacy devices are devices that continue to be placed on the EU market under applicable MDR or IVDR transitional provisions based on certificates or declarations issued under the previous medical device Directives. They can remain subject to EUDAMED registration requirements even though they are not fully MDR- or IVDR-certified devices.
Applicable legacy devices must be registered when the EUDAMED transitional provisions require registration. For example, where additional units of an applicable legacy device continue to be placed on the market after May 28, 2026, registration is generally required by November 28, 2026.
Legacy devices are not subject to the MDR/IVDR UDI requirements in the same way as Regulation devices and therefore do not require assignment of a Basic UDI-DI solely for legacy-device registration. EUDAMED provides specific identifiers and registration structures for legacy devices.
The EUDAMED DI serves as the primary identifier for a legacy device registration where a Basic UDI-DI is not applicable. The manufacturer can assign the EUDAMED DI according to the applicable EUDAMED rules.
Where a legacy device does not have an applicable UDI-DI, EUDAMED can generate a EUDAMED ID to identify the device within the system. Legacy-device identification therefore differs from the Basic UDI-DI and UDI-DI structure used for MDR/IVDR Regulation devices.
Not always.
Where a legacy device and its corresponding Regulation device are considered the same device under the applicable transitional rules, registration of the Regulation device can remove the need for a separate legacy-device registration. This generally depends on whether the devices share identifiers and characteristics. A Regulation device requiring a new UDI-DI because of relevant changes would generally not be considered the same device.
No.
Devices described as “old” devices—that is, devices placed on the market before the applicable MDR or IVDR date and not qualifying as legacy devices—cannot be registered in the UDI/Devices module. Limited device information may still be required if such a device becomes involved in a serious incident or Field Safety Corrective Action once the applicable Vigilance functionality becomes mandatory.
Key Takeaway
Legacy-device registration follows different identification and data rules from MDR/IVDR device registration. Manufacturers should first determine whether a separate legacy record is actually required before creating duplicate records for legacy and Regulation versions of the same device.
Submitting Device Data to EUDAMED
EUDAMED supports different approaches for managing UDI/device data, including:
- Web Portal: Manual entry and maintenance through EUDAMED
- XML upload: Upload of structured device data files
- Machine-to-Machine (M2M): Automated system-to-system exchange.
The appropriate approach depends largely on portfolio size, submission volume, source systems, and automation requirements.
Manual registration can be practical for manufacturers with relatively small device portfolios or low registration volumes. For larger portfolios, manually maintaining individual records can become difficult to scale and can increase the risk of inconsistent or outdated information.
XML Upload enables manufacturers to prepare structured UDI/device information outside EUDAMED and submit it using EUDAMED-supported XML formats. This can be useful for manufacturers managing larger datasets without implementing a fully automated M2M integration.
Machine-to-Machine submission enables an organization’s systems to exchange structured device information directly with EUDAMED. It is designed for manufacturers and solution providers managing larger submission volumes or requiring more automated regulatory data processes.
Technology and service providers can support manufacturers in preparing, validating, and transmitting EUDAMED data using supported submission mechanisms. However, manufacturers remain responsible for the accuracy and regulatory compliance of the information submitted for their devices.
Key Takeaway
EUDAMED supports both manual and automated device registration. Manufacturers should select a submission approach that matches their product portfolio size and operating model while establishing validation controls before regulatory data reaches EUDAMED.
Maintaining EUDAMED Compliance
No.
Manufacturers must maintain accurate EUDAMED information throughout the applicable device lifecycle. EUDAMED submission should therefore be incorporated into product change-management, regulatory data governance, and ongoing compliance processes rather than treated as a one-time registration project.
Manufacturers must assess changes to determine whether the existing EUDAMED record can be updated or whether the change requires assignment of a new UDI-DI. Changes to certain device characteristics can trigger a new UDI-DI under MDR/IVDR and issuing-entity rules.
A new UDI-DI is required when a change could lead to misidentification of the device or ambiguity in its traceability.
Examples can include changes to:
- Name or trade name
- Device version or model
- Labeled single-use status
- Sterile packaging
- Need for sterilization before use
- Quantity of devices provided in a package
- Critical warnings or contraindications
- Certain software characteristics.
The applicable MDR/IVDR and issuing-entity rules should be used to determine whether a specific change triggers a new UDI-DI.
Manufacturers should establish processes to:
- Maintain authoritative UDI and device master data
- Monitor regulatory and product changes
- Determine whether changes trigger new identifiers
- Validate data before submission
- Maintain alignment between EUDAMED and internal source systems
- Monitor submission status and resolve errors
- Maintain appropriate auditability and data governance.
Key Takeaway
EUDAMED compliance does not end when a device is successfully registered. Sustainable compliance requires manufacturers to govern device data, manage product changes, monitor registrations, and keep EUDAMED synchronized with authoritative regulatory information.
Conclusion
With the UDI/Devices module mandatory since May 28, 2026, EUDAMED has moved from a future regulatory initiative to an active compliance requirement for device manufacturers. Manufacturers placing new MDR and IVDR devices on the EU market must now incorporate EUDAMED registration into their standard market-entry processes, while organizations with applicable devices already on the market should address the November 28, 2026 transitional registration deadline.
Successful EUDAMED compliance also requires more than completing an initial device registration. Manufacturers need a trusted source of regulatory device data, well-governed Basic UDI-DIs and UDI-DIs, clearly defined data ownership, appropriate validation controls, and processes for keeping EUDAMED current as products and regulatory information change. Organizations managing large or global device portfolios should therefore approach EUDAMED as an ongoing regulatory data-management process that can support accurate, scalable, and sustainable compliance throughout the device lifecycle.
