EU IVDR UDI System under Article 24: Assignment, Carriers and Class-Based Deadlines

1. Key takeaways

The Unique Device Identification (UDI) system is established under Article 24 and consists of the UDI-DI, the device identifier specific to a manufacturer and a device, and the UDI-PI, the production identifier identifying the unit of production and, where applicable, the packaging units, as set out in Article 24(1)(a). The manufacturer must assign the UDI to the device and all higher levels of packaging before placing it on the market, under Article 24(3). The deadlines for placing the UDI carrier on the label are staggered by class: Class D on 2023-05-26, Class B and Class C on 2025-05-26, and Class A on 2027-05-26, in accordance with Article 113(3)(e).

Because assignment and carrier placement are separate obligations with different dates, planning is essential. Devices already on the market at the date of application already required assignment, while Class A products still face a carrier deadline ahead. Companies that treat the UDI system as a single labelling project usually discover late that the master data, the issuing entity choice and the database submission are the critical path, not the artwork itself.

2. Legal basis

3. Expert insights

Insight 1: Assignment and carrier placement are two distinct obligations at two different points in time.

Article 24(3) requires the manufacturer to assign the UDI to the device before it is placed on the market and to submit the core data elements referred to in Annex VI Part B relating to the UDI to the UDI database. Article 24(4) separately requires the UDI carrier to be placed on the label of the device and on all higher levels of packaging, with transport containers excepted. The application dates for the carrier obligation are staggered by class under Article 113(3)(e), whereas the assignment obligation has applied since the date of application of the Regulation, 2022-05-26. Organisations that scheduled only one date per class risk having devices on the market without assigned UDIs and without the required database submission, which is a compliance gap independent of the label artwork.

Insight 2: The issuing entity is designated by the Commission, and its qualification carries quantified thresholds.

Under Article 24(2), an issuing entity must be an organisation with legal personality whose assigning system is adequate to identify devices throughout their distribution and use, complies with the relevant international standards, is open to all interested users on predetermined and transparent terms, and commits to keep its assigning system operating for at least 10 years after designation. For manufacturers, the consequence is that the choice of issuing entity is a long-term decision: the identifier system selected must remain stable and accessible for the life of the product portfolio, and switching systems later carries costs across labelling, registrations and supply chain records. The decision belongs in the project plan before label redesign begins, not after.

Insight 3: The UDI is not only a label element; it is also the index key for vigilance and traceability.

Article 24(5) provides that the UDI is used for reporting serious incidents and field safety corrective actions (FSCA) under Article 82, which makes the identifiers a mandatory field in vigilance workflows rather than a marketing detail. Article 24(8) requires economic operators to keep records of the UDIs of the devices they have supplied or received, for the classes or groups of devices determined by the measures adopted under Article 24(11)(a). Article 24(9) encourages, or allows Member States to require, health institutions and healthcare professionals to keep such records. Read together, these provisions make the UDI the connective tissue of the traceability chain from manufacturer to point of use, and every internal system that handles incidents or supply records should carry UDI fields accordingly.

Insight 4: The Basic UDI-DI is the connection key between documentation and databases.

Article 24(6) requires the Basic UDI-DI to appear on the EU Declaration of Conformity, and Article 24(7) requires the manufacturer to retain in the technical documentation, as part of Annex II, the latest list of all UDIs assigned. Taken together with the device-level identifiers, the three tiers, Basic UDI-DI, UDI-DI and UDI-PI, form a complete hierarchy from documents to individual units. This hierarchy should be designed once and used everywhere: registration records, the DoC, the technical documentation list and vigilance forms all point into the same structures, and discrepancies between the tiers are among the most frequent findings in registration audits.

4. Practical recommendations

1. First select the issuing entity and complete the assignment of Basic UDI-DI and UDI-DI values, then schedule the label redesign, so that artwork work is not redone when identifiers change.
2. Schedule the carrier-on-label milestones per class under Article 113(3)(e), planning the Class A artwork well ahead of 2027-05-26, and confirm the higher packaging levels and the transport container exception in the same pass.
3. Maintain a UDI master data ledger, kept consistent with the UDI list in the technical documentation under Article 24(7) and with the EUDAMED records, with one accountable owner for the data.
4. Include UDI fields in the vigilance and FSCA report templates under Article 24(5), so that incident reporting and traceability use the same identifiers.
5. Agree the UDI record-keeping arrangements with importers and distributors under Article 24(8) and write them into contracts, defining which device classes or groups are covered.

5. Verification checklist

• □ UDI assignment and database submission have been completed before placing devices on the market, under Article 24(3)
• □ Carrier-on-label dates have been scheduled per class: Class D 2023-05-26, Classes B and C 2025-05-26, Class A 2027-05-26
• □ The Basic UDI-DI appears on the EU DoC under Article 24(6)
• □ The UDI list in the technical documentation has been established and kept updated under Article 24(7)
• □ Vigilance and FSCA report templates include UDI fields under Article 24(5)
• □ UDI record-keeping obligations of importers and distributors are covered in contracts under Article 24(8)

GRZAN supports manufacturers entering or operating in the EU in vitro diagnostic market with UDI system implementation under the IVDR: issuing entity selection, Basic UDI-DI and UDI-DI assignment, carrier-on-label scheduling per class against Article 113(3)(e), master data ledgers and EUDAMED submission support. Contact us at info@grzanglobal.com to plan your UDI rollout.

Legal information verified as of 29 October 2026.