EU IVDR Device Registration in the UDI Database and EUDAMED: SRN and Articles 25-26

1. Key takeaways

The UDI database is established under Article 25, which refers to the electronic system set up under Article 28 of the MDR. Article 26 carries the device registration obligation: before placing a device on the market, the manufacturer must obtain a single registration number (SRN) under Article 28 and submit the device information of Annex VI Part A Section 2 together with the UDI data of Annex VI Part B to EUDAMED. From 2026-05-28, the first four EUDAMED modules become mandatory, and device registration must be completed within that system.

Two practical points frame everything else. First, registration is a sequence: the SRN is obtained through economic operator registration, and only then can device records be submitted, so any delay in operator registration delays every device on the portfolio. Second, data maintenance is a standing duty with defined deadlines and confirmation cycles, meaning that registration is not a one-time submission but an ongoing data operation that must be staffed and calendared.

2. Legal basis

3. Expert insights

Insight 1: The order is first the SRN, then the devices, and it cannot be reversed.

Article 28(1) requires manufacturers, authorised representatives and importers to submit the information of Annex VI Part A Section 1 to the electronic system referred to in Article 30 before placing a device on the market, thereby obtaining their SRN. Article 28(3) then states that the manufacturer shall use the SRN when applying for conformity assessment to a notified body, and when accessing EUDAMED to fulfil the obligations under Article 26. Without the SRN, device records simply cannot be submitted, and notified body applications are not processed. Project planning should therefore treat operator registration as the first milestone of any EU launch, because it gates both the conformity assessment and the registration of every device in the portfolio.

Insight 2: Legacy devices use the EUDAMED-DI and do not need a Basic UDI-DI.

According to MDCG 2019-5 and the Commission questions and answers on the progressive rollout of EUDAMED, legacy devices can be registered in the UDI/Devices module using a system-generated EUDAMED-DI, without a Basic UDI-DI assigned by an issuing entity. This distinction determines whether a manufacturer must first complete UDI assignment when registering legacy devices, which materially changes the project scope: legacy registration becomes a data-entry exercise rather than a coding project. Manufacturers should nevertheless verify which devices qualify as legacy in their portfolio, because the answer defines which pathway, and the difference should be documented so that registration teams apply it consistently.

Insight 3: Data maintenance is a continuous obligation, with a periodic confirmation duty.

Article 28(4) requires economic operators to update the information referred to within 1 week of a change. Article 28(5) requires verification of the accuracy of the data within 1 year of the first submission and thereafter every 2 years; where the economic operator fails to verify the data within 6 months of the deadlines, any Member State may take appropriate corrective measures on its territory. Article 28(7) further provides that the data recorded in the first subparagraph shall be publicly accessible. These are not soft expectations: the one-week update duty must be embedded in change management, and the confirmation calendar must be owned by a named person, because missed confirmations trigger real corrective measures.

Insight 4: Member States may charge fees on the basis of Article 28(8).

Article 28(8) allows competent authorities to charge manufacturers, authorised representatives or importers in accordance with Article 104. The level of fees must be transparent and based on the cost-recovery principle under Article 104(1), and the structure of the fees must be notified to the Commission and the other Member States at least 3 months in advance under Article 104(2). For budgeting purposes this means registration costs vary by Member State and can change over time as fee structures are published. Compliance budgets should carry a line for registration fees, and teams should track national fee notifications so that renewals and new registrations are not delayed by unbudgeted charges.

4. Practical recommendations

1. Apply for the SRN at project start and treat it as the prerequisite node for both the notified body application and device registration, tracking it in the launch plan as a gating milestone.
2. Build an EUDAMED data maintenance responsibility table defining who submits, who updates and who performs the periodic accuracy confirmations under Article 28(5).
3. Embed the duty to update within 1 week of a change into the change management procedure under Article 28(4), with a checklist identifying which registered records each type of change touches.
4. Register legacy devices through the EUDAMED-DI pathway and verify the data items against the list in MDCG 2019-5, documenting which devices qualify for that pathway.
5. Include potential national registration fees under Articles 28(8) and 104 in the annual compliance budget and monitor fee structure notifications.

5. Verification checklist

• □ The SRN has been obtained under Article 28 and is used for the notified body application and device registration
• □ Device information and UDI data have been submitted in accordance with Annex VI Part A Section 2 and Part B
• □ An update mechanism within 1 week of any change has been established under Article 28(4)
• □ An annual and biennial data confirmation calendar has been set up under Article 28(5)
• □ Legacy devices have been confirmed for registration through the EUDAMED-DI pathway
• □ Potential Member State registration fees are included in the budget under Articles 28(8) and 104

GRZAN supports manufacturers entering or operating in the EU in vitro diagnostic market with device registration in the UDI database and EUDAMED under the IVDR: SRN onboarding, Annex VI Part A and Part B data preparation, legacy device registration via the EUDAMED-DI pathway, maintenance calendars under Articles 28(4) and 28(5) and fee budgeting support. Contact us at info@grzanglobal.com to set up your registration operations.

Legal information verified as of 29 October 2026.