UDI and EUDAMED: What Manufacturers Need to Know and Do

Why UDI and EUDAMED matter beyond compliance

The Unique Device Identification (UDI) system and the EUDAMED database exist to make medical devices traceable across their entire lifecycle — from manufacture through distribution to post-market surveillance. For manufacturers, they translate into concrete operational obligations: you have to assign identifiers to your devices, label them correctly, and register them in a central EU database before you can legally place them on the EU market.

Getting this wrong is not just a documentation problem. If your device is not correctly registered in EUDAMED, it can be challenged at the point of customs, purchase, or market surveillance — regardless of whether your CE certification is in order. Think of UDI and EUDAMED registration as the operational layer that runs alongside your technical compliance work, not as an optional step at the end.

Understanding the UDI structure

A UDI consists of two parts. The Device Identifier (UDI-DI) identifies the device model — it is specific to a combination of device, labelling, and packaging configuration. The Production Identifier (UDI-PI) identifies the specific production unit — it can carry information like lot number, serial number, manufacturing date, or expiry date. The UDI-DI is what gets registered in EUDAMED. The UDI-PI appears on the label and in the device master record.

UDIs are issued by accredited issuing entities: GS1 (using GTIN-based identifiers), HIBCC, and ICCBBA. You choose one and apply to become a member. The issuing entity gives you the framework to generate your own UDI-DIs — they do not generate them for you for each product. The system then requires that your UDIs be printed on the device label (as both human-readable text and a machine-readable barcode or datamatrix), on each level of packaging, and in your technical documentation.

What has to go into EUDAMED

EUDAMED is the EU's central medical device database. It has multiple modules: actor registration (manufacturers, authorised representatives, importers), UDI/device registration, notified body and certificate information, clinical investigations, vigilance, and market surveillance. Manufacturers interact primarily with the actor registration module and the UDI/device registration module.

Before placing a device on the EU market, you must:

1. Register your organisation as an actor in EUDAMED (obtaining an SRN — Single Registration Number)
2. Register each device's UDI-DI in the UDI/device registration module
3. Keep that registration current — if anything changes (labelling, intended purpose, device configuration), the registration needs updating

The SRN is not just an administrative reference. It needs to appear on your label for certain device classes, and national competent authorities use it to link your organisation to your device registrations. If your Authorised Representative is handling some of this on your behalf, make sure there is a clear ownership structure — both your organisation and your AR can have registration obligations, and confusion about who owns what leads to gaps.

The phased rollout and where things stand

MDR set out a phased timeline for UDI labelling and EUDAMED registration by device class, and that timeline has been subject to delays. As of early 2026, UDI labelling is mandatory for Class III and Class IIb implantable devices, with Class IIa and Class IIb non-implantable following, and Class I and Class Is/Im following after. EUDAMED modules have come into force progressively. The current status of each module is published on the European Commission website — checking this regularly is important because the timeline has moved before.

One thing that catches manufacturers off guard: EUDAMED registration requirements apply to devices already on the market, not just new ones. Legacy devices under MDD certificates still being sold need to be registered once the relevant obligations kick in. Teams managing large device portfolios often underestimate the cataloguing work involved in getting all their UDI-DIs registered accurately.

Practical steps to get started

If you have not started with UDI and EUDAMED yet, the sequence looks like this:

1. Identify your issuing entity and become a member (allow several weeks for this process)
2. Audit your device portfolio — catalogue every distinct device configuration that will need its own UDI-DI
3. Assign UDI-DIs to each configuration and plan the labelling updates
4. Register your organisation in EUDAMED to get your SRN
5. Register each device's UDI-DI in EUDAMED once the module obligations apply to your device class
6. Build a process for keeping registrations current as devices change

The cataloguing step is where most teams discover they have more distinct device configurations than they thought. Different packaging sizes, different sterile and non-sterile variants, devices sold in kits — each can require its own UDI-DI. Starting the inventory early saves significant rework later.