Where exactly does the UDI carrier have to be placed under MDR?

Article 27(4) requires the UDI carrier on the label of the device and on all higher levels of packaging. Annex VI Part C, Section 4.1 adds that it may be placed on the device itself instead of a label, which is how devices with no label of their own comply. Reusable devices must additionally be directly marked under Section 4.10. Shipping containers are expressly excluded from both provisions.

Does the UDI carrier go on the shipping box?

No. Article 27(4) states that higher levels of packaging shall not be understood to include shipping containers, and Annex VI Part C, Section 3.2 exempts them from the UDI requirement as well. Part C defines a shipping container as one whose traceability is controlled by a process specific to logistics systems. If the outer box is a trade item a hospital orders and stocks as a unit, it is a packaging level and does need a carrier.

Do I need both a barcode and human readable text?

Normally yes. Part C defines the UDI carrier as the means of conveying the UDI using AIDC and, if applicable, its HRI. Section 4.7 allows AIDC alone where there are significant constraints limiting the use of both on the label, but reverses that for devices used outside healthcare facilities, such as home-care devices, where the HRI must appear even at the cost of the AIDC. If RFID is used, a linear or 2D barcode is also required on the label.

When did UDI carrier requirements start applying to class I devices?

Article 123(3)(f) applies Article 27(4) to class I devices from 26 May 2025, after implantable and class III devices from 26 May 2021 and class IIa and IIb from 26 May 2023. Reusable class I devices that must bear the carrier on the device itself have until 26 May 2027 under Article 123(3)(g)(iii), as amended by Regulation (EU) 2020/561. The certificate extensions in Regulation (EU) 2023/607 did not change these dates.

Is the Basic UDI-DI printed in the UDI carrier?

No. The carrier encodes the UDI, which is the UDI-DI plus, where applicable, the UDI-PI such as a lot or serial number. The Basic UDI-DI is a model-level identifier that never appears on the label or in the carrier; under Article 27(6) it appears on the EU declaration of conformity and, for notified-body devices, on certificates. The two identifiers serve different purposes and must not be interchanged in Eudamed submissions.

Can a distributor or repackager apply the UDI carrier?

Annex VI Part C, Section 2.3 provides that only the manufacturer may place the UDI on the device or its packaging. A company that repackages or relabels a device under its own name becomes a manufacturer for MDR purposes in the circumstances set out in Article 16, and Section 3.10 then requires it to retain a record of the original manufacturer's UDI. A distributor acting as a distributor cannot add or alter a carrier.

UDI Carrier Requirements Under MDR: Where the Carrier Goes and From When

Q: Which reusable devices are exempt from direct marking?

Annex VI Part C, Section 4.10 exempts a device only where any type of direct marking would interfere with the safety or performance of the device, or where the device cannot be directly marked because it is not technologically feasible. Both grounds are narrow and must be justified and documented in the technical documentation. Cost, production complexity and inconvenience are not grounds for exemption.

Sep 6

7 min read

Under MDR 2017/745 the UDI carrier goes in three places: on the label of the device, on every higher level of its packaging, and — for reusable devices — directly on the device itself. Shipping containers are deliberately left out. Those placements are the whole of the UDI carrier requirements; the rest of Annex VI Part C is detail about how the carrier is drawn, which packaging levels can be skipped, and from which date each class of device had to comply.

The obligation is timed by class. Implantable and class III devices have had to carry it since 26 May 2021, class IIa and IIb since 26 May 2023, and class I since 26 May 2025. Direct marking of reusable devices follows two years behind each of those dates, ending with class I reusables on 26 May 2027. Every one of those dates sits in Article 123(3), and none of them has been postponed.

Article 27(4): the placement rule in one sentence

The operative text is short. Article 27(4) provides that "UDI carriers shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging shall not be understood to include shipping containers." (MDR Article 27(4)) The sentence does two jobs at once. It fixes the minimum placements — label plus all higher packaging levels — and it removes the outermost logistics layer from scope, so a manufacturer does not have to barcode the pallet or the transport carton that the individually labelled cartons travel in.

Annex I, Section 23.2(h) then lists "the UDI carrier referred to in Article 27(4) and Part C of Annex VI" (MDR Annex I, Section 23.2(h)) among the particulars the label itself must bear, which is why the carrier is a labelling item and not merely a database exercise. The rest of the label content is covered in our guide to medical device labelling requirements.

How the UDI carrier requirements work across packaging levels

Annex VI Part C, Section 4.1 restates and slightly widens Article 27(4): "The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers." (MDR Annex VI, Part C, Section 4.1) The addition of or on the device itself matters — a device with no label of its own, such as a bare instrument, satisfies the rule by direct marking.

Each packaging level carries its own UDI-DI, so a box of ten is not the same identifier as the single unit inside it. Where a level genuinely cannot take a carrier, Section 4.2 gives relief: "In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level." (MDR Annex VI, Part C, Section 4.2)

Section 4.3 adds a further relief: "For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices." (MDR Annex VI, Part C, Section 4.3) Where the healthcare provider is not expected to reach that higher level, as in home healthcare, the UDI goes on the individual packaging after all. Section 4.12 removes duplication: "If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the device's packaging, the placing of the UDI carrier on the packaging shall not be required." (MDR Annex VI, Part C, Section 4.12)

Why shipping containers sit outside the UDI carrier requirements

The exclusion is not an oversight, and it is stated twice. Article 27(4) says higher levels of packaging shall not be understood to include shipping containers, and Section 3.2 of Annex VI Part C repeats it for the UDI itself: "Shipping containers shall be exempted from the requirement in Section 3.1." (MDR Annex VI, Part C, Section 3.2) The reasoning is in the definition. Part C, Section 1 defines a shipping container as follows: "A shipping container is a container in relation to which traceability is controlled by a process specific to logistics systems." (MDR Annex VI, Part C, Section 1)

The test is therefore functional, not physical. If the outer box exists only because a customer ordered twelve units and its traceability is handled by a despatch note or consignment number, it is a shipping container and needs no carrier. If the same box is a defined trade item a hospital stocks and reorders as a unit, it is a packaging level and needs one. Treating every outer case as exempt is a common error.

AIDC and HRI: what the carrier must actually show

A UDI carrier is not simply a barcode. Part C, Section 1 defines it: "The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI." (MDR Annex VI, Part C, Section 1) The same section defines the readable half: "HRI is a legible interpretation of the data characters encoded in the UDI carrier." (MDR Annex VI, Part C, Section 1) In practice a compliant carrier normally shows a machine-readable symbol plus the same data in plain characters next to it.

Section 4.7 sets out the only relief, and it runs one way: "If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label." (MDR Annex VI, Part C, Section 4.7) The same provision then reverses the priority for devices used outside healthcare facilities, such as home-care devices, where the HRI must appear even if that leaves no room for the AIDC. Where RFID is chosen, Section 4.9 requires a fallback: "If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label." (MDR Annex VI, Part C, Section 4.9)

Section 4.11 adds a durability condition: "The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device." (MDR Annex VI, Part C, Section 4.11) A carrier printed on a peel-off sticker discarded at unpacking does not meet it.

Direct marking of reusable devices, and the two exemptions

The direct-marking duty is not in Article 27(4) itself; it is in Annex VI Part C, Section 4.10, which Article 123(3)(g) then times by reference to Article 27(4). Section 4.10 opens: "Devices that are reusable shall bear a UDI carrier on the device itself." (MDR Annex VI, Part C, Section 4.10) It continues: "The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device." (MDR Annex VI, Part C, Section 4.10) That is a materials and process requirement as much as a regulatory one — laser etching, dot peen or an equivalent that survives repeated autoclaving.

Section 4.10 then exempts a device where "any type of direct marking would interfere with the safety or performance of the device" (MDR Annex VI, Part C, Section 4.10(a)) or where "the device cannot be directly marked because it is not technologically feasible" (MDR Annex VI, Part C, Section 4.10(b)) Both are narrow and both must be justified and documented in the technical documentation; neither is a general hardship clause, and cost or inconvenience is not among the grounds. Note also Section 4.13: for a single finished device made up of parts that must be assembled before first use, marking one part is enough.

Application dates for the UDI carrier requirements, by class

Article 123(3)(f) staggers Article 27(4) by risk class: "for implantable devices and for class III devices Article 27(4) shall apply from 26 May 2021. For class IIa and class IIb devices Article 27(4) shall apply from 26 May 2023. For class I devices Article 27(4) shall apply from 26 May 2025" (MDR Article 123(3)(f)). Point (g), as amended by Regulation (EU) 2020/561, then adds two years for reusable devices that must bear the carrier on the device itself, and spells out the resulting dates: "with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to:" (MDR Article 123(3)(g)) implantable devices and class III devices from 26 May 2023; class IIa and class IIb devices from 26 May 2025; class I devices from 26 May 2027. None of these dates was moved by the certificate extensions in Regulation (EU) 2023/607, which changed Article 120, not Article 123(3)(f) or (g).

Device category	UDI carrier on label and packaging from	Direct marking of reusables from	Legal basis
Implantable devices and class III	26 May 2021	26 May 2023	Art. 123(3)(f); Art. 123(3)(g)(i)
Class IIa and class IIb	26 May 2023	26 May 2025	Art. 123(3)(f); Art. 123(3)(g)(ii)
Class I (including class Im, Is, Ir)	26 May 2025	26 May 2027	Art. 123(3)(f); Art. 123(3)(g)(iii)

Two consequences follow. The date turns on the class, so a classification error becomes a carrier-timing error too — see medical device classification under MDR. And the date governs the carrier only: assigning a UDI and submitting data under Articles 27(3) and 29 is timed by Article 123(3)(d) and (e) instead.

The UDI-DI in the carrier is not the Basic UDI-DI

The code encoded in the carrier is the UDI: a UDI-DI plus, where applicable, a UDI-PI such as a lot or serial number. The Basic UDI-DI never appears in the carrier at all — it is the model-level identifier that appears on the EU declaration of conformity and on certificates, under Article 27(6). Confusing the two is the most common error in UDI data submissions; the relationship is set out in full in our post on the Basic UDI-DI.

Where Medex fits

As EU authorised representative under Article 11 — EUDAMED SRN TR-AR-000057550 — Medex verifies that the UDI has been assigned and that the declaration of conformity and Eudamed entries are consistent before a device is placed on the market, and handles Eudamed registration for the manufacturers it represents. Medex does not perform notified-body conformity assessment, does not write clients' technical documentation and does not source distributors; artwork and direct-marking decisions remain the manufacturer's. If you want the UDI carrier requirements checked against your artwork before submission, get in touch.