UDI Carrier Timeline under MDR Article 123(3)(g): Dates by Class

UDI carrier deadlines in the EU MDR arrive in phases that differ by device class and by carrier location. This article explains the two separate timelines under MDR Article 123(3)(g), why the 2027 date for Class I reusable devices matters, and how the carrier duty differs from the EUDAMED registration duty.

1. Key takeaways

Under MDR Article 123(3)(g), the application of UDI carriers on labels is phased in three stages by device class: Class III and implantable devices from 2021-05-26; Class IIb and Class IIa devices from 2023-05-26; and Class I devices from 2025-05-26. For reusable devices, for which the UDI carrier must be placed on the device itself, the corresponding dates are 2023-05-26, 2025-05-26 and 2027-05-26.

The label timeline has now fully expired for all classes, while the device-itself timeline still has one date ahead for Class I reusable devices. The two schedules must not be conflated, and the carrier duty must also be kept distinct from the duty to register UDI data in the EUDAMED database, which becomes mandatory from 2026-05-28 under Commission Decision (EU) 2025/2371.

For planning purposes, the two timelines should be entered into the product roadmap as separate milestone rows, because they are driven by different provisions and fail independently. A device can be fully compliant on the label timeline while still missing its device-itself milestone, and the reverse is not possible: the device-itself marking never substitutes for the carrier on the label and the higher packaging levels, both of which remain required under Article 27(4).

2. Legal basis

The table below lists the provisions and sources cited in this article.

The phase dates above are fixed in the text of Article 123(3)(g) and are echoed in national authority summaries such as the Irish HPRA page, which is useful as an operational cross-check when planning product roadmaps.

3. Expert insights

Insight one: two timelines must be distinguished — the carrier on the label and the carrier on the device itself.

The first timeline governs when the UDI carrier must appear on the label: Class III and implantable devices from 2021-05-26, Class IIb and IIa from 2023-05-26, and Class I from 2025-05-26. The second timeline governs when reusable devices must carry the UDI carrier directly on the device itself: Class III from 2023-05-26, Class IIb and IIa from 2025-05-26, and Class I from 2027-05-26. All label deadlines have expired; the device-itself timeline still holds one open milestone for Class I reusable devices.

Insight two: 26 May 2027 for Class I reusable devices is the next hard deadline.

For Class I reusable devices still in use, the UDI carrier must be placed on the device itself from 2027-05-26, and under the requirements of Annex VI the marking must be permanent and remain readable after each reprocessing cycle. This is a product design and process task, since direct part marking of metal components differs fundamentally from printed labels, and it cannot be completed by merely updating the label artwork. Process validation must therefore start well ahead of the deadline.

Insight three: this timeline is not the same as the legacy certificate transition period.

The dates of 2027-12-31 and 2028-12-31 in Article 120(3a) govern how long legacy devices may continue to be placed on the market; the date of 2027-05-26 in Article 123(3)(g) governs when the UDI carrier must appear on the device itself. The two have different legal sources and different consequences, and neither can substitute for or offset the other in planning.

Insight four: the UDI carrier and the UDI database registration are two independent obligations.

Even where carriers have been applied according to the timeline, the registration of UDI data in the database under Article 29 remains a separate duty. From 2026-05-28 the EUDAMED UDI and device registration module is mandatory, following Commission Decision (EU) 2025/2371, so the two obligations run in parallel and are checked in parallel during market surveillance.

The verification of readability after reprocessing deserves particular care in the validation plan, because marking methods degrade differently under cleaning agents, autoclave cycles and mechanical abrasion. The validation protocol should therefore sample the full specified cycle count, not an abbreviated run, and define objective acceptance criteria for readability before the process is released for production.

4. Practical recommendations

1. Build a matrix of device class against reusability and determine the applicable carrier deadline for every SKU individually.
2. Start permanent marking process validation for Class I reusable devices early, including readability verification after reprocessing.
3. Split the UDI carrier duty and the UDI database registration duty into two separate check lines, each with its own pre-release checkpoint.
4. Link marking validation with the sterilisation and reprocessing validation, confirming that the marking remains readable after the specified number of cycles.
5. Enter 2027-05-26 into the schedule for product changes and process modifications now, so tooling and validation work lands before the deadline.

Because the two obligation lines run in parallel, the release checkpoint for a single batch should verify both at once: that the carrier is present and readable at every required level, and that the database record for the Basic UDI-DI and UDI-DI is complete and current. Splitting the checks into two named lines with different owners keeps responsibility clear when one of them fails.

5. Verification checklist

• □ A class-by-reusability matrix has been built and applied to every SKU
• □ Label UDI carriers are in place according to the class timeline (2021-05-26 / 2023-05-26 / 2025-05-26)
• □ Reusable devices are scheduled against 2023-05-26 / 2025-05-26 / 2027-05-26
• □ Permanent marking process validation for Class I reusable devices has started
• □ Marking readability after reprocessing has been verified
• □ UDI database registration status has been confirmed (mandatory module from 2026-05-28)

Regulatory information verified as of 2026-10-29.

GRZAN supports medical device manufacturers entering and maintaining the EU market under Regulation (EU) 2017/745. Our team maps UDI carrier deadlines under MDR Article 123(3)(g) to individual SKUs, validates permanent marking processes, and coordinates carrier duties with EUDAMED registration. For technical file and conformity support for the EU MDR market, contact info@grzanglobal.com.