From May 28, 2026, the EUDAMED UDI/Devices module becomes mandatory for medical device manufacturers placing products on the EU market. Before investing time, internal resources, or paid submission tools, the first question worth answering is simpler than most assume: which of your devices actually need a UDI-DI in EUDAMED, and which do not? This guide walks through the scope, the identifiers, the genuine exemptions, and the access prerequisites that often delay registration by weeks.

What EUDAMED Requires — and When

Commission Decision (EU) 2025/2371 of 26 November 2025 declared four EUDAMED modules functional and mandatory from 28 May 2026: Actor registration, UDI/Device registration, Notified Bodies and Certificates, and Market Surveillance. The remaining two modules (Clinical Investigations and Vigilance) will follow on a later date.

For the UDI/Devices module specifically, two deadlines apply:

Important: device registration in EUDAMED is the manufacturer’s responsibility. According to the official EUDAMED User Guide, Authorised Representatives and Importers cannot register devices or System and Procedure Packs on behalf of a manufacturer. This is a frequent misunderstanding among SMEs that delegate regulatory work to an AR.

The Three Identifiers: Basic UDI-DI, UDI-DI, Package UDI-DI

The single most common source of confusion in EUDAMED registration is the difference between the identifiers. The official EUDAMED User Guide (v2.27.0, 2026) groups them as three distinct codes that work together inside the UDI/Devices module:

A frequent mistake: confusing UDI-PI with UDI-DI. The Production Identifier (UDI-PI) carries batch, lot, serial or expiry data and appears on the physical label. The EUDAMED User Guide is explicit: “In EUDAMED, device/SPP registration in the UDI/Devices module means registering a device/SPP at the level of the device identifier. Production identifiers are not required.” UDI-PI exists, but it is not entered into the EUDAMED registration.

Which Medical Devices Need a UDI-DI

The default rule under MDR Article 27 and IVDR Article 24 is broad: every device placed on the EU market needs a UDI assigned by the manufacturer and registered in EUDAMED. The obligation applies regardless of risk class:

Risk class influences when the UDI carrier must appear on the device. Under MDR Article 123(3)(g), the staggered deadlines for direct marking of UDI on reusable devices are: from 26 May 2023 for Class III and implantable devices, from 26 May 2025 for Class IIa and Class IIb devices, and from 26 May 2027 for Class I devices. These deadlines affect the physical marking on the device itself; they do not change whether a UDI-DI is required in EUDAMED. If the device is on the EU market under MDR or IVDR, a UDI-DI must be registered.

Which Devices Are Exempt

The exemptions are narrow and well-defined. MDR Article 27(1) explicitly excludes custom-made devices from the UDI requirement; investigational devices fall outside the UDI/Devices module because they are governed by the separate clinical investigation regime (MDR Articles 62–82); and Article 5(5) creates a third practical exemption for in-house devices:

A special case worth noting: spectacle frames, spectacle lenses and ready-to-wear reading spectacles can use the Master UDI-DI solution defined in MDCG guidance, which adapts the standard structure to the realities of the optical sector. Manufacturers in adjacent niches sometimes ask whether similar accommodations exist for their product type — the answer is generally no; the Master UDI-DI is sector-specific.

Exempt from UDI does not mean exempt from EUDAMED. Even manufacturers of custom-made or in-house devices have obligations — including actor registration, vigilance reporting where applicable, and (for custom-made devices) the specific declarations required by MDR Annex XIII.

Five Common Mistakes That Delay Registration

Based on the EUDAMED User Guide and public MDCG guidance, these are the recurring errors that turn a one-day registration into a several-week ordeal:

  1. Attempting to register devices before the access chain is complete. EUDAMED requires, in order: an EU Login (ECAS) account, registration of the manufacturer in the Actor (ACT) module, approval by a Local Actor Administrator (LAA), and an upgrade of the user profile from Viewer to Proposer or Confirmer. Skipping any of these steps blocks device entry.
  2. Treating the Basic UDI-DI as a product catalogue number. The Basic UDI-DI groups devices by intended purpose, risk class and design family — not by SKU. Creating one Basic UDI-DI per pack size is wrong and creates downstream certificate issues.
  3. Issuing UDI codes without an Issuing Entity contract in place. Only four entities are designated by the Commission: GS1, HIBCC, ICCBBA and IFA. The Basic UDI-DI and UDI-DI must follow the format of the chosen entity; switching later is painful.
  4. Delegating device registration to an Authorised Representative or Importer. Per the official User Guide, only manufacturers and SPP producers can register devices in EUDAMED. The AR’s role is upstream of registration, not a substitute for it.
  5. Assuming “possible in EUDAMED” equals “allowed by MDR/IVDR.” The User Guide is explicit: “EUDAMED does not contain all constraints defined in the MDR/IVDR, guidance and good practices, and therefore, it is not because something is possible in EUDAMED that it is necessarily allowed.” The platform validates structure, not regulatory compliance.

Before Investing in a Submission Tool

The market for EUDAMED submission tools is real, and several vendors offer machine-to-machine APIs that genuinely save time for large manufacturers. But before subscribing, three checks pay for themselves:

  1. Confirm your registration scope. Count the devices that actually need a UDI-DI under your MDR/IVDR portfolio, separating regulation devices from any legacy devices still benefitting from Article 120 transitional provisions. A small manufacturer with under 20 UDI-DIs per year rarely needs an automated tool.
  2. Use the EUDAMED Playground environment first. The European Commission provides a separate Playground instance with dummy Actor IDs/SRNs intended for testing the registration flow without committing live data. Most teams discover their information gaps here, not by paying a vendor.
  3. Make sure your Issuing Entity decision is made. The UDI format is locked to the entity you choose. Pick this before evaluating any submission tool, since tool compatibility depends on it.

Manual submission through the EUDAMED web interface remains the practical choice for portfolios under 50–100 UDI-DIs per year, especially since the interface is available in all official EU languages and accepts data entered in any of them. Automated tools become genuinely cost-effective higher up the volume curve, or where ERP/QMS integration is the real driver.

Plan your UDI registration scope

Use our free MDR Classification Wizard to confirm which of your devices fall under MDR (and therefore need a UDI-DI), and the Submission Tracker to organize your EUDAMED registration timeline.

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