Systems and Procedure Packs Under MDR Article 22

What Are Systems and Procedure Packs?

Systems and procedure packs are combinations of products placed on the EU market for a specific medical purpose. Regulation (EU) 2017/745 defines them in Article 2 and sets the rules in Article 22. The person who combines the products is called the system or procedure pack producer in MDCG 2018-3 Rev.1.

The main difference is packaging. Products in a procedure pack are packaged together. Products in a system may or may not be packaged together, but they are intended to be interconnected or combined. A combination can sometimes meet both definitions, and the duties under Article 22 are the same.

What are common examples?

The right answer always depends on the intended medical purpose and on how the products are placed on the market. These examples show how the terms are commonly used:

Which products can be included?

Under Article 22(1), a producer can combine CE-marked devices with:

• Other devices that bear the CE marking.
• In vitro diagnostic devices that bear the CE marking under Regulation (EU) 2017/746. See our IVDR guide.
• Other products that conform to the legislation that applies to them, only where they are used within a medical procedure or their presence is otherwise justified.

What Must Systems and Procedure Packs Producers Do?

Among the EU MDR procedure pack requirements, the central duty is the Article 22(2) statement. It is not a declaration that the combination is a new CE-marked device. It confirms how the combination was verified, packaged and controlled. In the statement, the producer declares that:

What evidence should support the procedure pack statement?

Article 22 does not list a full technical file for a pack that stays within Article 22. However, the producer still needs evidence behind each declaration. A practical file usually includes:

• The intended medical purpose and a complete component list.
• A specification for the combined system or pack.
• CE certificates, declarations of conformity and instructions for each component.
• A compatibility assessment and a risk analysis for the combination.
• A justification for any non-device product.
• Verification, validation and in-process monitoring records.

How long must the statement be kept?

The statement must stay available to competent authorities for the Article 10(8) period that applies to the combined devices. That is at least 10 years, or at least 15 years for implantable devices. If the periods differ, the longest applies.

When should the statement be reviewed?

The statement describes a specific combination, so it should not be treated as a one-time document. Review it when a component, supplier, manufacturer instruction, intended purpose, sterilisation method or packaging changes. Also review it when a component’s CE certificate or legal status changes. A change could affect compatibility, shelf life or labelling, and it could move the combination into Article 22(4).

What must be registered in EUDAMED?

The producer registers as an actor to obtain a Single Registration Number (SRN). Before placing the combination on the market, the producer assigns a Basic UDI-DI and submits the core data, as required by Article 29(2). The HPRA reports that mandatory use of the EUDAMED actor and UDI/device modules began on 28 May 2026. New devices must be registered before first placement, and earlier-placed devices by 28 November 2026.

How Are Sterile Systems and Procedure Packs Assessed?

Sterile combinations need extra planning. Sterilising a system or pack before placing it on the market requires a notified body. Under Article 22(3), the producer selects Annex IX or Annex XI Part A. Notified body involvement is limited to the aspects that ensure sterility until the sterile packaging is opened or damaged.

The producer must also state that sterilisation followed the manufacturer’s instructions. Check that each component’s instructions allow the chosen method, and plan the sterilisation validation early.

What Labelling and UDI Do Systems and Procedure Packs Need?

Under Article 22(5), the combination must not bear an additional CE marking. It must show the producer’s name, registered trade name or registered trade mark, and an address for contact. It must also carry the information in Annex I, section 23.

Under MDCG 2018-3, the combination has its own UDI, with a UDI-DI and UDI-PI. The Basic UDI-DI identifies combinations with the same group of components and the same intended purpose. Annex VI Part C generally places the UDI carrier on the outside of the packaging. Check whether each component also needs its own carrier inside the pack.

Systems and Procedure Packs Support from I3CGLOBAL

I3CGLOBAL is a global regulatory consulting company for medical devices, IVDs, pharmaceuticals and life sciences. Our EU MDR consultants provide procedure pack compliance support, from the first route decision through to maintenance. Non-EU companies can also ask about EU representative services.

Every project starts with your component list, intended purpose and target markets. We use these to show which duties apply to your combination, what evidence already exists and where the gaps are. You then receive a clear plan that separates the producer route from full device conformity assessment.

Official References and Related Guides

• Regulation (EU) 2017/745 (MDR), Articles 2(10), 2(11), 22, 29(2) and 52
• MDCG 2018-3 Rev.1: UDI for systems and procedure packs
• EUDAMED help: registering a system or procedure pack
• HPRA: mandatory use of EUDAMED modules
• Norwegian Medical Products Agency: systems and procedure packs

• Medical Device CE Marking
• Medical Device Technical File
• EUDAMED Registration
• MDR Article 117
• Sterilization Validation
• CE Marking Consultants

Updated 7 November 2026 | Author: Sobha Augustine, Founder, I3CGLOBAL | Reviewed by: Asha Johnson, Manager, I3CGLOBAL