When is a medical kit a procedure pack—and when is it a new device?

A procedure pack is a combination of products packaged together and placed on the market for a specific medical purpose. A system is a combination of products, packaged together or not, intended to be interconnected or combined for a specific medical purpose. The regulatory route in Article 22 is substantially the same, but the physical presentation and UDI-carrier placement may differ.

No additional CE marking is placed on a compliant system or procedure pack assembled under Article 22(1). The individual devices retain their own CE markings. The outer product must identify the system or procedure pack producer and carry the required information and its own UDI. If Article 22(4) applies, the combination is treated as a device in its own right and follows the applicable conformity assessment and CE-marking route.

Yes, but only when those products comply with the legislation applicable to them and are used within a medical procedure or their presence is otherwise justified. Their use must remain compatible with the intended purposes and limits specified by the relevant manufacturers. A convenience item is not automatically justified merely because it fits in the box.

No. If a component that should be a medical device does not bear the required CE marking, the Article 22(1) route is unavailable. Under Article 22(4), the combination is treated as a device in its own right and the responsible person assumes manufacturer obligations and must complete the applicable conformity assessment.

Not merely because compliant CE-marked devices are combined under Article 22(1). A Notified Body is required under Article 22(3) when the producer sterilises the system or procedure pack for placing it on the market; its involvement is limited to the aspects that ensure sterility until the sterile packaging is opened or damaged. Full Notified Body involvement may also arise when Article 22(4) makes the combination a device in its own right and its classification requires it.

The producer declares that mutual compatibility was verified in accordance with the component manufacturers’ instructions, that combining activities followed those instructions, that the system or procedure pack was packaged with the relevant information for users, and that combining was controlled through appropriate internal monitoring, verification and validation. A sterilising producer also declares that sterilisation followed the manufacturers’ instructions.

It must remain available to competent authorities for the Article 10(8) retention period applicable to the combined devices. If the periods differ, the longest applies. This generally means at least 10 years after the last relevant device was placed on the market and at least 15 years where an implantable device determines the longer period.

Yes. Article 22 systems and procedure packs receive their own Basic UDI-DI and UDI, distinct from the identifiers of their components. The UDI carrier is generally placed on the outside of the pack, or must remain readable or scannable through transparent packaging. Since 28 May 2026, the EUDAMED Actor and UDI/Devices modules are mandatory to use.

No. MDCG guidance distinguishes a combination placed on the market for a specific medical purpose from products merely supplied together at a customer’s request. If the supplier neither markets the products as one combination nor intends them to be used together for a specific medical purpose, it may remain ordinary distribution rather than Article 22 production.