Under MDR Article 22, a kit or procedure pack combining multiple CE-marked devices into a single offering is itself treated as a system or procedure pack, and the natural or legal person who puts it together. The system or procedure pack producer. Has distinct obligations. For UDI purposes, this means the kit itself carries its own UDI-DI at the kit level, assigned by the system producer under the rules of a Commission-designated issuing entity and placed on the kit label in accordance with Annex VI Part C. The individual CE-marked components inside the kit keep their own UDIs from their original manufacturers. The kit-level UDI identifies the assembled package; the component UDIs identify each device inside it. Both layers coexist. Neither replaces the other, and both must be traceable through the supply chain.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • MDR Article 22 governs systems and procedure packs. Combinations of CE-marked devices (and sometimes other products) placed on the market as a single unit for a specific medical purpose.
  • The system or procedure pack producer is the natural or legal person who assembles the combination. Under Article 22(1) and 22(3), that producer takes on specific obligations, including a written declaration for the combination.
  • A kit placed on the market as a system or procedure pack under Article 22 is identified by a kit-level UDI-DI assigned by the system producer, following the rules of a Commission-designated issuing entity (GS1, HIBCC, ICCBBA, or IFA).
  • The individual CE-marked components inside the kit keep the UDIs assigned by their original manufacturers. Those UDIs are not removed or overwritten.
  • Annex VI Part C of the MDR sets out when and how the kit-level UDI is carried on the kit label and in the UDI carrier, alongside the component identifiers inside.

The problem a founder hits on day one

A founder designs a procedure pack for a specific surgical workflow. Inside the pack are six CE-marked devices from three different manufacturers: a pre-sterilised drape, a suction set, two clamps, a sterile saline bottle, and a single-use cautery tip. The pack is sold as one SKU, for one procedure, with one IFU on the outside. The hospital scans one barcode at intake. That barcode needs to mean something. But what?

Does the kit get its own UDI? Do the component UDIs still matter? What happens when one component's lot changes while the others stay the same? Who is the manufacturer of the kit for regulatory purposes. The assembler, or the original component makers?

These questions are not edge cases. They are the ordinary questions any team assembling a kit under MDR has to answer before the first unit ships. This post walks through them, grounded in MDR Article 22, Article 27, and Annex VI Part C. The conceptual orientation to UDI as a whole sits in What is UDI?, and the article-by-article reading of the UDI regime is in MDR Articles 27 to 29 UDI requirements decoded.

Article 22. Systems and procedure packs

MDR Article 22 is titled "Systems and procedure packs" and it does three jobs.

Article 22(1) recognises that a natural or legal person can combine CE-marked devices together with other CE-marked devices (and, under specific conditions, with non-device products such as medicinal products or products falling under other regulations) to place them on the market as a system or procedure pack. The combination is made for a specific medical purpose and is offered as one unit. For each combination, the person assembling it draws up a written statement. Commonly called the Article 22 declaration. Confirming specific facts about the combination.

Article 22(1)(a) to (e) sets out what that written statement must confirm, including that the mutual compatibility of the devices has been verified in accordance with the manufacturers' instructions, that the system or procedure pack has been packaged and relevant information supplied to users incorporating the information to be supplied by the manufacturers of the devices that have been put together, and that the activity of combining devices was subjected to appropriate internal monitoring, verification, and validation.

Article 22(3) addresses the case where the system or procedure pack incorporates devices that do not bear the CE marking, or where the chosen combination of devices is not compatible in view of their original intended purpose, or where sterilisation has been carried out to place the combination on the market in a sterile condition. In those cases, the system or procedure pack is treated as a device in its own right, and the person assembling it takes on full manufacturer obligations under the MDR. Including conformity assessment for the combination as a whole.

Article 22(4) clarifies that systems and procedure packs referred to in Article 22(1). The "declaration" route. Do not themselves bear an additional CE marking, but they must carry the name, registered trade name or registered trade mark of the person making the combination, the address at which they can be contacted, and the information referred to in Annex I Section 23 relating to the information supplied with the device.

Read together, Article 22 creates two distinct regimes. The first is the declaration route under 22(1). Combining already-CE-marked devices without becoming their manufacturer, with a written statement and the Article 22 obligations. The second is the full-manufacturer route under 22(3). Where sterilisation, incompatible combinations, or non-CE-marked components force the assembler to take on manufacturer obligations for the combination.

Which regime applies matters enormously for UDI, because it determines who the manufacturer of the kit is, and therefore who assigns the kit-level UDI.

The kit-level UDI

A kit placed on the market under Article 22 needs to be identifiable as a kit. A hospital does not scan the inside of the pack at goods-in. It scans the outer label. That scan has to resolve to the kit, not to one of its components picked at random.

MDR Article 27 requires every device other than custom-made and investigational to carry a UDI. Annex VI Part C sets out the structure. UDI-DI plus applicable UDI-PI elements. And the carrier requirements. For a system or procedure pack placed on the market under Article 22, the kit itself is the thing being placed on the market. It carries a kit-level UDI-DI, assigned by the system or procedure pack producer under the rules of the chosen issuing entity (GS1, HIBCC, ICCBBA, or IFA), together with the applicable UDI-PI elements for the kit. Typically the lot number of the assembly run, the expiry date where the kit has a defined shelf life, and the manufacturing date where that is the relevant anchor.

The kit-level UDI-DI is unique to the specific combination. Change the combination. Swap one component for a different model, add a new component, remove one. And the kit is a different kit with a different UDI-DI. A new size, a new variant of the pack, a new packaging configuration: each is its own UDI-DI.

The kit-level UDI carrier is placed on the outer label and on higher packaging levels in accordance with Annex VI Part C. Human-readable interpretation accompanies the machine-readable carrier. If the kit falls under the declaration route of Article 22(1), it does not bear an additional CE marking, but it does bear the assembler's name and address under Article 22(4) and it does carry its own UDI.

The mental model is clean. The kit is a thing placed on the market. The thing placed on the market needs a UDI. The producer of that thing. The Article 22 assembler. Is the party that assigns it.

The component UDIs

The components inside the kit do not lose their UDIs. Each CE-marked device inside the pack was manufactured by a legal manufacturer who assigned a UDI under Article 27 when they first placed the device on the market. That UDI stays on the component. Packaging a device into a kit does not strip its identity.

This matters for several reasons. First, traceability to the original manufacturer remains intact. If a specific lot of clamps turns out to have a non-conformity, the recall has to reach every unit of that lot. Including the clamps inside assembled kits. The component UDI is how the recall finds them. Second, vigilance reporting under Articles 87 and 88 relies on being able to identify which specific device was involved in an incident. If a drape inside a procedure pack is implicated, the drape's own UDI is the identifier used. Third, the hospital's own inventory and traceability systems often scan at the component level when the pack is opened in the operating room. Each component is logged individually against the patient record.

The result is that an assembled procedure pack carries identity at two layers. The outer label carries the kit-level UDI-DI assigned by the Article 22 producer. The inner components carry their original manufacturer-assigned UDIs. Neither layer replaces the other. Both are required for full traceability, and both survive through the supply chain.

A corollary: the Article 22 producer cannot overwrite or re-label component UDIs. Removing a component manufacturer's UDI and replacing it with a producer-assigned identifier is not permitted. The component UDIs are the property of the component manufacturers and the instruments of their own regulatory obligations.

The system or procedure pack producer obligation

Under Article 22(1), the person combining the devices into a system or procedure pack is not automatically the manufacturer of the combination. They are the system or procedure pack producer, with the specific obligations laid out in Article 22.

For UDI, those obligations include the following practical steps. The producer chooses an issuing entity (GS1, HIBCC, ICCBBA, or IFA) under which to assign kit-level UDIs. They define the UDI-DI structure so that each kit configuration has its own identifier. They define the applicable UDI-PI elements for the kit. Usually driven by the sterilisation regime, the shelf life of the combined pack, and the batch-level assembly process. They design the kit label to carry the kit-level UDI carrier in machine-readable and human-readable form under Annex VI Part C. They ensure that the Article 22 written statement is drawn up and retained. And they register the kit in EUDAMED as required under the applicable rules for Article 22 combinations, noting the specific EUDAMED treatment of systems and procedure packs.

If the kit falls under Article 22(3). Because it is sterilised before placing on the market, or because the combination is incompatible with the components' original intended purposes, or because it contains non-CE-marked elements. The producer is treated as the manufacturer of the combination. In that case, full Article 10 manufacturer obligations apply, full conformity assessment for the combination is required, and the UDI regime follows the ordinary manufacturer path: Basic UDI-DI, UDI-DIs, UDI-PIs, EUDAMED submission under Article 29, Notified Body involvement where the classification requires it. The kit is no longer just a combination; it is a device in its own right.

The distinction between 22(1) and 22(3) is the single most important question a kit producer answers, because it determines the entire regulatory footprint. Including the UDI structure above the kit.

Multi-component examples

Three concrete examples make the structure visible.

A non-sterile procedure pack under Article 22(1). Six CE-marked devices assembled together for a specific surgical workflow, not sterilised by the assembler, all components compatible with their original intended purposes, no non-CE-marked elements. The assembler draws up the Article 22(1) written statement. The kit carries a kit-level UDI-DI assigned by the assembler under GS1 rules, with the kit's lot number as the UDI-PI. Inside the pack, each component keeps its original manufacturer's UDI on its own primary packaging. The outer label shows the kit UDI and the assembler's name and address. The kit does not bear an additional CE marking.

A sterile procedure pack under Article 22(3). The same six devices, but the assembler terminally sterilises the combined pack before placing it on the market. Article 22(3) applies: the assembler is treated as the manufacturer of the combination for MDR purposes. The kit is a device in its own right, classified under Annex VIII, subject to full conformity assessment, and assigned a Basic UDI-DI, a UDI-DI, and UDI-PIs by the assembler acting as manufacturer. The component UDIs remain intact inside, but the kit's own UDI is now a full manufacturer-assigned UDI with all the Article 29 database submission obligations attached.

A mixed system incorporating a medicinal product. A kit that combines CE-marked devices with a medicinal product in its final packaging, placed on the market as a single offering for a specific medical purpose. Article 22 governs the combination, with the specific treatment of medicinal products and the interaction with Regulation (EU) 2017/745 Article 1 scope. The UDI structure is built around the Article 22 framework: a kit-level UDI-DI for the combination, component UDIs inside, and careful reading of which regime. 22(1) or 22(3). Applies given the specific configuration.

In every case the logic is the same. Identify which Article 22 route applies. Assign a kit-level UDI accordingly. Leave the component UDIs alone.

Common mistakes

Assuming the kit UDI replaces the component UDIs. It does not. Both layers coexist. Stripping component UDIs is a regulatory and traceability failure.

Treating Article 22(1) as a lighter version of manufacturing. The declaration route has real obligations. The written statement, mutual compatibility verification, the information supplied to users, internal monitoring. It is not a shortcut around Article 10; it is a distinct regime with its own requirements.

Missing the 22(1) versus 22(3) determination. Sterilising the combined pack, introducing a non-CE-marked element, or combining components in a way incompatible with their original intended purposes pushes the producer into full manufacturer territory. Teams that miss this end up with a kit UDI but without the manufacturer obligations that should have come with it.

Using one UDI-DI for multiple kit configurations. A new configuration is a new kit. A new size, a new component swap, a new packaging level. Each gets its own kit-level UDI-DI. Reusing one identifier across variants defeats traceability.

Forgetting Annex VI Part C on the kit label. The kit UDI carrier is governed by the same Annex VI Part C rules as any other UDI carrier: machine-readable plus human-readable, on the label and on higher packaging levels. A kit label without a compliant carrier is a label without a UDI.

Ignoring EUDAMED treatment of Article 22 combinations. Systems and procedure packs have specific EUDAMED handling. The kit-level registration is not identical to a standalone device registration, and the producer's role needs to be correctly represented. Read the specific EUDAMED guidance for Article 22 combinations before first submission.

The Subtract to Ship angle on kit UDIs

Kits are where the Subtract to Ship framework for MDR earns its keep, because kit projects accumulate speculative work faster than single-device projects. A kit touches three or more manufacturers, two layers of UDI, an Article 22 written statement, and a label design that has to survive both the outer scan and the inner contents.

The real work is finite. Determine whether Article 22(1) or Article 22(3) applies, and write the determination down with its reasoning. Draw up the Article 22 written statement. Choose an issuing entity. Assign a kit-level UDI-DI per kit configuration and define the applicable UDI-PI elements. Design the kit label under Annex VI Part C. Preserve the component UDIs. Register the kit in EUDAMED under the Article 22 regime that applies. That is the list.

Everything outside that list is a candidate for removal. Parallel UDI schemes that overwrite component identifiers, custom kit-identifier databases that duplicate EUDAMED, speculative RFID layers for kit-level tracking that are not grounded in Annex VI Part C, "kit governance frameworks" that do not end in an Article 22 determination. All waste. If a proposed activity does not trace to Article 22, Article 27, Annex VI Part C, or the issuing entity rules, it comes out.

Reality Check. Is your kit UDI story solid?

  1. Have you determined whether your kit falls under Article 22(1) (declaration route) or Article 22(3) (full manufacturer route), with the reasoning written down?
  2. Do you have the Article 22(1) written statement drafted, covering mutual compatibility, packaging, information supplied to users, and internal monitoring?
  3. Have you chosen a UDI issuing entity for the kit-level UDI-DI and confirmed that the choice is consistent with the component manufacturers' ecosystems?
  4. Can you state the kit-level UDI-DI for each kit configuration and packaging level?
  5. Have you defined which UDI-PI elements apply to the kit. Lot, expiry, manufacturing date. And documented the reasoning?
  6. Does your kit label carry the kit-level UDI in machine-readable and human-readable form per Annex VI Part C?
  7. Are the component UDIs preserved intact on each component inside the kit?
  8. Have you confirmed the EUDAMED registration approach for Article 22 combinations and mapped it to your SRN and producer role?

If you cannot answer five or more of these cleanly, the kit UDI is not yet a solved workstream.

Frequently Asked Questions

Does a procedure pack get its own UDI under MDR? Yes. A procedure pack placed on the market under MDR Article 22 is identified by a kit-level UDI-DI assigned by the system or procedure pack producer under the rules of a Commission-designated issuing entity, with applicable UDI-PI elements, carried on the kit label under Annex VI Part C.

Do the individual components inside the kit keep their UDIs? Yes. The UDIs assigned by the original component manufacturers stay intact. Packaging devices into a kit does not remove their identifiers. Both the kit-level UDI and the component UDIs are required for full traceability.

Who assigns the kit-level UDI? The system or procedure pack producer. The natural or legal person who combines the devices under Article 22. Under Article 22(1), that producer is not the manufacturer of the components, but they are the producer of the combination and they assign the kit-level UDI-DI under their chosen issuing entity's rules.

What is the difference between Article 22(1) and Article 22(3)? Article 22(1) is the declaration route: CE-marked devices combined without sterilisation or incompatibility, with a written statement from the producer. Article 22(3) applies when the combination is sterilised before placing on the market, contains non-CE-marked elements, or combines devices in a way incompatible with their original intended purposes. In which case the producer is treated as the manufacturer of the combination with full Article 10 obligations.

Does an Article 22(1) kit bear an additional CE marking? No. Article 22(4) makes clear that systems and procedure packs under Article 22(1) do not bear an additional CE marking, but they must carry the name, registered trade name or trade mark of the producer, a contact address, and the information supplied with the device under Annex I Section 23.

Where is the kit-level UDI carrier placed? On the outer label of the kit and on all higher levels of packaging, in accordance with Annex VI Part C. The carrier is machine-readable (typically a linear barcode or a 2D data matrix) and accompanied by a human-readable interpretation.

Do component UDIs still need to be scanned when the kit is opened? That is a hospital operational decision rather than a regulatory requirement imposed on the producer, but the component UDIs must remain present and legible on each component so that hospital systems, vigilance investigators, and recall workflows can identify individual devices. Preserving component UDIs is a regulatory obligation of the kit producer; scanning them at point of use is a hospital choice.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 22 (systems and procedure packs), Article 27 (Unique Device Identification system), and Annex VI Part C (the UDI system, including UDI-DI and UDI-PI structure, carrier requirements, and change categories). Official Journal L 117, 5.5.2017.
  2. Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed). OJ L 426, 29.11.2021.

This post is part of the EUDAMED, UDI and Registration category in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. For questions about how Article 22 and the UDI regime apply to a specific kit configuration. Particularly the determination between the declaration route and the full manufacturer route. Read this post alongside What is UDI? and MDR Articles 27-29 UDI requirements decoded.