MDR Article 22: Systems, Procedure Packs and Who Becomes Responsible

Why Article 22 exists

Hospitals do not buy devices one at a time. They buy a caesarean set, an arterial line kit, a dental implant tray, an X-ray installation. Somebody assembles those combinations, and that somebody is usually not the manufacturer of any component in them. Article 22 of Regulation (EU) 2017/745 is the provision that decides what that person owes the Union market — and, in a small number of cases, decides that they have quietly become a manufacturer.

It rests on two definitions in Article 2. A "‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose", while a "‘system’ means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose". The distinguishing element in both is the specific medical purpose that the assembler intends. Without that intent, there is no system and no procedure pack.

What Article 22(1) covers, and what it does not

Article 22(1) applies where a natural or legal person combines CE-marked devices with any of three things, compatibly with each product's intended purpose and within the limits of use specified by their manufacturers: other CE-marked devices; CE-marked in vitro diagnostic medical devices conforming to Regulation (EU) 2017/746; or other products conforming to the legislation that applies to them, where those products are used within a medical procedure or their presence is otherwise justified.

That last category is the one people forget. A sterile drape, a scalpel and a marker pen can sit in the same tray. The drape and scalpel are devices; the marker pen is not, and it does not need to be, provided it complies with whatever law does govern it and its presence in the pack is justified.

The Article 22(2) statement: three things you are declaring

The person who assembles the pack does not issue an EU declaration of conformity. They issue a statement, and Article 22(2) fixes its content precisely. In it they declare that:

1. they verified the mutual compatibility of the devices and, if applicable, other products, in accordance with the manufacturers' instructions, and carried out their activities in accordance with those instructions;

2. they packaged the system or procedure pack and supplied relevant information to users, incorporating the information to be supplied by the manufacturers of the products put together;

3. the activity of combining the products was subject to appropriate methods of internal monitoring, verification and validation.

Point three is where audits go wrong. "Appropriate methods of internal monitoring, verification and validation" is a quality-system obligation in everything but name. It is not satisfied by a packing list. Article 22(5) requires the statement to be kept at the disposal of competent authorities for the period applicable under Article 10(8) to the combined devices, and where those retention periods differ, the longest one governs.

When combining CE-marked devices does not create a system or procedure pack

This is the most useful and least known part of the subject, and it comes from MDCG 2018-3 Rev.1. A person in the supply chain may put different CE-marked products into one shipment at a client's or hospital's request without the entire combination being placed on the market by them or intended by them for a specific medical purpose. In that case the combination is not a system or procedure pack at all, and that person is a distributor under Article 2(34), not a system or procedure pack producer.

The guidance gives two examples. A distributor supplying, on a client's request, sterile tweezers, a sterile needle and surgery gloves in one shipment. And multi-device surgical sets delivered in trays for replenishment and sterilisation, assembled for the convenience of the healthcare provider. Neither triggers Article 22.

The test is intent and placing on the market, not physical proximity. If your catalogue offers "hip revision kit, reference HRK-2" as a product with a stated clinical use, you are a system or procedure pack producer. If your warehouse ships whatever a theatre manager listed on a purchase order, you are a distributor doing distribution.

Sterilisation: the only route into a notified body under Article 22(3)

Anyone who sterilises a system or procedure pack for the purpose of placing it on the market must apply either one of the procedures in Annex IX or the procedure in Part A of Annex XI, at their choice, and must draw up a statement that sterilisation was carried out in accordance with the manufacturer's instructions. Crucially, the scope is narrow: "The application of those procedures and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged."

The notified body is not reviewing the clinical suitability of the pack, its design, or the components. It is auditing sterility assurance and nothing else. That is a far smaller certificate than a full conformity assessment, and it produces no CE marking of its own.

When Article 22(4) turns the pack into a device

Three failures convert a pack into a device in its own right: "Where the system or procedure pack incorporates devices which 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 the sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52." The next sentence is the one that changes a company: the natural or legal person shall assume the obligations incumbent on manufacturers.

"Not compatible in view of their original intended purpose" is the trap that catches innovative pack designers. Combining a CE-marked catheter with a CE-marked syringe in a way neither manufacturer contemplated is not clever kitting; it is manufacturing a new device.

	Article 22(1) and (3) producer	Article 22(4) manufacturer
Instrument issued	Statement under Article 22(2)	EU declaration of conformity
CE marking on the pack	None — components keep theirs	Yes, on the pack as a device
Notified body	Only for sterility, and only under Article 22(3)	Full conformity assessment under Article 52
Technical documentation	Not required as such; compatibility and validation records are	Annexes II and III in full
EU Authorised Representative if based outside the EU	Not required	Required under Article 11
Clinical evaluation	Not required for the pack	Required under Article 61

Registration: an identity that is not an SRN

Article 2(35) lists the person referred to in Article 22(1) and 22(3) as an economic operator in their own right, alongside manufacturers, authorised representatives, importers and distributors. Article 29(2) then requires that before placing a system or procedure pack on the market, that person assigns it a Basic UDI-DI and provides it to the UDI database together with the core data elements in Part B of Annex VI.

To do that they must be registered as an actor in EUDAMED — and here is the detail almost nobody outside the database knows. MDCG 2021-13 Rev.1 states that registered system and procedure pack producers are assigned an Actor ID that is not an SRN. The identifier looks similar, functions similarly, and is formally a different thing from the single registration number that manufacturers, authorised representatives and importers receive under Article 31.

Two further consequences follow from the same guidance. A producer established outside the Union has no obligation to designate an authorised representative — Article 11 is written for manufacturers, and an Article 22(1) producer is not one. And for such a producer, the competent authority responsible for approving the registration is the authority of the place where the first system or procedure pack of that producer is to be placed on the market. Choosing that Member State is a real decision, and MDCG 2021-13 asks the producer to explain the choice in the free-text field of the registration request.

Assignment of the Basic UDI-DI follows a specific rule too: it identifies packs having the same group of components and the same intended purpose, regardless of who manufactured the original components. That is deliberate, so that swapping a component supplier does not force a new Basic UDI-DI. The wider mechanics are covered in our post on the Basic UDI-DI, and we handle the database side as part of EUDAMED registration.

Labelling the pack

Article 22(5) is blunt about marking: "The systems or procedure packs referred to in paragraph 1 of this Article shall not themselves bear an additional CE marking". What the pack must bear instead is the name, registered trade name or registered trade mark of the Article 22(1) or 22(3) person, and an address at which that person can be contacted so that their location can be established. The pack must also be accompanied by the information referred to in Section 23 of Annex I — which in practice means the component manufacturers' instructions travel with the pack, consolidated so a user can actually follow them.

If you are unsure which side of Article 22(4) your assembly sits on, that question is worth resolving before the first shipment rather than after an inspection. Our team is reachable at contact.