MDR Article 22: The Line Between Producer and Manufacturer

Article 22 of Regulation (EU) 2017/745 is the provision that lets a hospital-kit assembler, a device distributor, or a systems integrator combine CE-marked devices into a procedure pack or a system without becoming a manufacturer and without applying a new CE mark to the combination. It is also the provision most teams treat as a formality — sign a declaration, ship the pack — when it is actually a conditional exemption. Three conditions break it, and when they do, the producer is not fined for a paperwork gap. It becomes the manufacturer, retroactively, of the whole assembled device.

What Article 22 actually covers

Article 2 draws the line between the two activities Article 22 governs. A procedure pack is a combination of products packaged together and placed on the market for a specific medical purpose — a first aid kit, an orthodontic procedure pack, a skin traction kit. A system is a combination of products, packaged together or not, intended to be inter-connected or combined to achieve a specific medical purpose — an X-ray system built from separately sourced components is the standard example. Article 22(1) lets a natural or legal person combine CE-marked medical devices, CE-marked in vitro diagnostics conformant with the EU MDR & IVDR framework, or other products whose own legislation applies only within the medical procedure, provided the combination is compatible with each device's intended purpose and stays within the limits of use its manufacturer specified.

The declaration is three specific promises, not one general one

Article 22(2) does not ask for a general statement of conformity. It requires three separate declarations, and a producer who cannot evidence all three does not have a valid Article 22 declaration regardless of what the document says:

1. Verified mutual compatibility. The producer confirms it checked the devices' — and any other products' — compatibility against each manufacturer's own instructions, and that its assembly activity followed those instructions.
2. Packaging and information. The producer packaged the system or pack and supplied users with the relevant information, incorporating what each constituent manufacturer already requires to be supplied — not a rewritten summary of it. See how this interacts with regulatory labeling obligations and the UDI data on the pack label, since the pack itself carries its own Basic UDI-DI as a distinct trade item.
3. Internal monitoring, verification, and validation. The combining activity itself — not just its output — was subject to documented internal controls. This is the element audits find weakest, because it is process evidence, not a finished declaration.

The declaration is not a summary of what the constituent manufacturers already certified. It is the producer's own evidence that it verified, packaged, and controlled the combination — three separate things a notified body or competent authority can ask to see proof of. Reading Article 22(2) as three obligations, not one

Where sterilization brings in a notified body

A system or procedure pack assembled entirely from CE-marked, compatible devices generally does not need notified body involvement. Sterilization changes that. Under Article 22(3), any producer who sterilizes the assembled system or pack before placing it on the market must apply one of the conformity assessment procedures in Annex IX or the procedure in Annex XI Part A, at its choice. The involvement of the notified body is deliberately narrow: it is limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged. It does not extend the notified body's review to the constituent devices themselves, which already carry their own CE marking and conformity assessment. Producers who skip this — sterilizing in-house without a notified-body-assessed procedure — create the single most common trigger for the manufacturer conversion described below, and one worth cross-checking against the notified body's designated scope before assuming a given NB can perform it.

The three conditions that make you a manufacturer

Article 22(4) sets out the conditions that strip a system or procedure pack of its Article 22 status entirely. If any one applies, the assembled pack is treated as a device in its own right and becomes subject to the full conformity assessment procedure under Article 52 — the same pathway a manufacturer of a newly designed device would follow. Article 22(5) then states the consequence directly: the natural or legal person assumes the obligations incumbent on manufacturers. The three conditions are:

• A non-CE-marked component. Any device or product in the combination that does not bear a valid CE marking removes the exemption for the whole assembly, not just that component.
• An incompatible combination. If the chosen combination is not compatible in view of the devices' original intended purpose — using components together in a way their own manufacturers did not intend or validate — Article 22 status is forfeited.
• Non-compliant sterilization. Sterilizing the pack other than in accordance with the manufacturer's instructions has the same effect, whether or not a notified body was otherwise involved.

None of this is exotic, but it is easy to under-govern because the Article 22 pathway feels administrative compared to full CE marking. It is not. A producer that cannot evidence the three declarations, that sterilizes outside a notified-body-assessed procedure, or that assumes compatibility instead of verifying it against the manufacturers' own instructions has, in the regulation's own terms, been manufacturing a device the whole time — it just has not been treating that as true. Teams building or auditing a systems/procedure-pack program should treat the declaration as a controlled document with the same rigor as a technical file, not a cover sheet.