Swissmedic information sheet on systems and procedure packs

From 4 August 2025, Swissmedic clarifies the obligations for systems and procedure packs (SPPs) containing at least one medical device in Switzerland and Liechtenstein, under the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). The guidance covers assembly, labelling, registration, notification and vigilance duties for economic operators.

Who is concerned

The information sheet addresses assemblers (SPPPs), Swiss authorised representatives (CH-REPs), importers, distributors and users making SPPs available on the Swiss market.

What SPPs are

• Procedure pack: a combination of devices packaged together and placed on the market for a specific medical purpose.
• System: a combination of devices, packaged together or not, intended to be interconnected or combined to achieve a specific medical purpose.

Each SPP contains at least one medical device, and the individual products must comply with applicable regulations and be combined according to their intended purposes.

Core obligations

1) Assembler’s statement

Any natural or legal person who combines devices to place them on the market as an SPP must draw up a statement declaring that:

• mutual compatibility has been verified and activities were carried out per manufacturers’ instructions;
• the SPP was packaged and relevant information supplied to users, incorporating the manufacturers’ information;
• appropriate internal monitoring, verification and validation methods were applied.

This statement must be kept available for the statutory retention period applicable to the combined devices (the longest period applies).

If an SPP is sterilised for placing on the market, the person who sterilises it must also draw up a statement that sterilisation followed the manufacturer’s instructions and that one of the procedures in Annex IX or Part A of Annex XI EU-MDR was applied. Completion is confirmed by a certificate of conformity from a designated/notified body. This Art. 22 statement is not a DoC for the individual devices.

2) When the SPP becomes a device in its own right

If an SPP includes devices without CE marking, or the combination is not compatible with the original intended purposes, or sterilisation was not performed per the manufacturer’s instructions, the SPP is treated as a device in its own right and is subject to a conformity assessment; the assembler/steriliser then fulfils manufacturer obligations and the SPP bears a CE marking.

3) Swiss authorised representative (CH-REP)

All individual devices in an SPP that are from foreign manufacturers must meet Swiss requirements, including mandating a CH-REP for each device. If the SPP is assembled or sterilised outside Switzerland, a CH-REP must also be mandated for the SPP. This CH-REP is responsible for the formal and safety-related aspects of placing the SPP on the market, while the CH-REPs for the individual devices remain responsible for their respective devices.

4) Labelling and product information

SPPs that are not devices in their own right do not bear an additional CE marking. They must, however, bear the name/trade name/trademark and contact address of the person(s) who assemble and sterilise the SPP, and, if the assembler is foreign, include the CH-REP details for the SPP on the labelling (legacy packs: on the label or IFU). In addition, the information required by Annex I Chapter III(23) EU-MDR (e.g., device name, identification, intended purpose where not obvious, manufacturer/CH-REP details, lot/serial number, expiry, storage/handling, single-use status, “medical device” indication, and IFU elements like performance, residual risks, training needs, sterile-pack instructions, revision date, and incident reporting notice) must be enclosed. Product information must be in all three Swiss official languages; fewer languages or English are allowed only in justified cases.

5) Registration

Registration: anyone placing SPPs on the market under Art. 11 MedDO must register their name and contact address with Swissmedic within three months after placing the SPP on the market.

6) Vigilance

Assemblers of SPPs made available in Switzerland must report serious incidents and field safety corrective actions to Swissmedic. If a CH-REP is required, the CH-REP is responsible for these reports. Healthcare professionals also have a legal duty to report serious incidents (materiovigilance).

FAQs at a glance

Swissmedic clarifies how legacy SPPs may continue to be placed on the market if devices meet the applicable requirements and transitional provisions; how to verify compliance for systems not packaged together or for packs that are sealed; and which labelling elements help identify conforming SPPs.

For more detailed information, please refer to the official Swissmedic information sheet available here: Swissmedic – Systems and procedure packs (MU600_00_018)