UDI Assignment and EUDAMED Registration: What Is Mandatory Now

Why UDI and EUDAMED are confusing — and why it matters

The phased rollout of EUDAMED has been extended multiple times since MDR's application date, which means the picture of what is mandatory now versus what is still voluntary keeps shifting. That confusion is not manufacturers' fault — the rollout has genuinely been unpredictable. The consequence is that some manufacturers have underinvested in EUDAMED readiness on the assumption that delays will continue, while others are uncertain what they are actually obligated to do today.

The practical answer is that the UDI system and some EUDAMED modules are now mandatory, regardless of where the broader EUDAMED rollout stands. Not having a UDI in place is not a posture that can be justified by pointing to delays in other modules. This resource walks through the actual obligations as they stand.

Step 1 — Understand the UDI structure

A UDI consists of two parts: the Device Identifier (UDI-DI) and the Production Identifier (UDI-PI). The UDI-DI identifies the device model — it is the same across all units of a given device version. The UDI-PI identifies the specific production unit: lot or batch number, serial number, manufacturing date, and/or expiry date, depending on what applies to your device.

The UDI-DI is what gets registered in EUDAMED. The UDI-PI appears on the label and packaging and, for active implantable devices and implantable devices, must be readable in the patient's health record.

UDI must be applied at each level of packaging: the device level, the higher packaging levels (box, case), and the shipping container. Not every packaging level requires the same data carrier, but each must carry the UDI in a format readable by both human and machine (AIDC — Automatic Identification and Data Capture, e.g., a barcode or QR code).

Step 2 — Select a UDI issuing entity

EUDAMED does not assign UDIs — you obtain your UDI from an issuing entity designated by the European Commission. The designated entities are GS1, HIBCC, and ICCBBA (for blood, cells, tissues, and organs). Each uses a different coding standard and data structure.

GS1 is by far the most widely used for medical devices. If your organisation already uses GS1 for other products, the choice is straightforward. If not, you need to register with the issuing entity and obtain your company prefix before you can generate any UDI-DIs. This takes time — build it into your timeline.

The issuing entity also defines the format of the data carrier (barcode type, QR code). Check your labelling and packaging process can produce and verify the required carrier format before you finalise your UDI structure.

Step 3 — Register the UDI-DI in EUDAMED

Once you have your UDI-DI, it must be registered in EUDAMED before the device is placed on the market. The EUDAMED UDI/device registration module (Module B) is the relevant module, and registration in this module is now mandatory.

The information required for UDI registration in EUDAMED includes: UDI-DI, device name, device description, risk class, applicable standards and Common Specifications, whether the device is intended for single use, whether it contains latex, whether it is sterile, and clinical size information if relevant. There is also a requirement to link the UDI-DI to the Basic UDI-DI — a higher-level grouping identifier that connects device variants sharing the same intended purpose, risk class, and common design.

The Basic UDI-DI is a common source of confusion. It is not printed on labels — it exists only in EUDAMED. One Basic UDI-DI can cover multiple UDI-DIs (different sizes, packaging configurations, variants) as long as those devices share the relevant characteristics. Getting the Basic UDI-DI structure right before you start registering individual UDI-DIs saves significant rework.

Step 4 — EUDAMED actor registration

Before you can register devices or UDIs, the manufacturer must be registered in EUDAMED as an actor (Module A). Actor registration is also mandatory. The actor registration captures the manufacturer's identity, address, and the Authorised Representative (if applicable). For non-EU manufacturers, the AR's EUDAMED registration must be in place before the manufacturer's devices can be registered.

Actor registration requires a Single Registration Number (SRN). The SRN is assigned by EUDAMED and is the manufacturer's identifier across all EUDAMED interactions. You will need the SRN for the DoC, for NB correspondence, and for labelling in some regulatory contexts.

What is still phased in — and what to watch

As of the time of writing, the modules for clinical investigations (Module C), vigilance (Module E), and post-market surveillance market surveillance (Module F) have had delayed mandatory application dates. These modules have been open for voluntary use but are not yet required for market access.

The EUDAMED dashboard at ec.europa.eu/tools/eudamed publishes the current mandatory/voluntary status of each module. Check this before making assumptions about what is required — the status has changed several times and may change again.

One obligation that is unambiguously in force regardless of EUDAMED module status: UDI labelling on the device itself. A device without a compliant UDI label cannot be placed on the EU market under MDR, regardless of whether EUDAMED registration is phased. These are separate obligations.

Common sticking points

SRN not obtained before NB contract. The NB needs the manufacturer's SRN as part of the certification process. Teams that have not completed actor registration before engaging an NB can find themselves in a delay they did not anticipate.

Basic UDI-DI structure designed incorrectly. Restructuring the Basic UDI-DI hierarchy after devices have been registered is complex and requires updating multiple linked records. Design this correctly before first registration.

Label artwork frozen before UDI carrier is validated. Artwork needs to be reissued if the AIDC carrier does not scan correctly. Run a verification scan of the physical label before artwork is approved for production.

EUDAMED account access issues at launch. EUDAMED access is managed per user. If the person who set up the account leaves the organisation, access problems can arise. Make sure at least two users have administrative access to your organisation's EUDAMED account at all times.