Swissmedic publishes updated guidance on Systems and Procedure Packs (SPP)
Swissmedic has released a new version (v1.2, valid from 23 March 2026) of its information sheet on systems and procedure packs (SPP), providing detailed clarification on regulatory obligations for economic operators placing these products on the Swiss market.
What are systems and procedure packs?
The document reinforces the distinction between systems and procedure packs:
A procedure pack is a combination of products packaged together for a specific medical purpose.
A system is a combination of products (packaged or not) intended to be interconnected to achieve a medical purpose.
Importantly, both must include at least one medical device and can combine devices with other products, provided all components comply with applicable regulations and are used according to their intended purpose.
Key regulatory obligations for manufacturers and assemblers
One of the central aspects of the guidance is the role of the assembler (System and Procedure Pack Producer – SPPP), who carries specific responsibilities.
Assemblers must:
Verify compatibility of all components according to manufacturers’ instructions
Ensure proper packaging and inclusion of all required product information
Implement internal monitoring, verification, and validation processes
Issue a formal statement under Article 22 EU MDR confirming compliance
This statement is not equivalent to a Declaration of Conformity for individual devices but is a mandatory regulatory document.
When an SPP becomes a medical device
Swissmedic highlights critical scenarios where an SPP is no longer treated as a simple combination, but as a medical device in its own right:
If included devices do not bear CE marking
If components are combined outside their intended purpose
If sterilisation is not performed according to manufacturer instructions
In such cases, the assembler assumes full manufacturer responsibilities, including conformity assessment and CE marking.
Impact for manufacturers:
This is a high-risk area. Incorrect combinations can unintentionally shift regulatory responsibility, significantly increasing compliance burden.
Swiss-specific requirements: CH-REP obligation
A major point of attention is the Swiss requirement for a Swiss Authorised Representative (CH-REP):
Each individual device within the SPP must have a CH-REP if the manufacturer is located outside Switzerland
Additionally, the SPP itself requires a CH-REP if assembled abroad
This requirement is specific to Switzerland and linked to the absence of a Mutual Recognition Agreement (MRA) with the EU.
Impact for manufacturers:
Companies exporting to Switzerland must carefully manage representation at both device level and system level, which can create duplication and operational complexity.
Labelling and documentation requirements
SPPs that are not considered devices do not carry their own CE mark but must include:
Identification of the assembler
Full product information from all included devices
CH-REP details (when applicable)
Instructions for use aligned with MDR Annex I requirements
Additionally, product information must generally be available in Switzerland’s official languages (with some flexibility).
Impact for manufacturers:
Ensuring consistency across multiple IFUs and labels becomes critical, especially when combining devices from different manufacturers.
Registration, notification and vigilance
The guidance also confirms that:
SPP assemblers must register with Swissmedic within 3 months of placing products on the market
Notification obligations remain applicable under transitional provisions
Assemblers and CH-REPs are responsible for vigilance reporting, including serious incidents and FSCA
Healthcare professionals also have a legal obligation to report incidents.
Transitional considerations
Swissmedic clarifies that SPPs under legacy legislation may still be placed on the market, provided all included devices comply with applicable transitional provisions.
However, new placements on the market require compliance with Article 22 EU MDR, including a formal statement.
What manufacturers should do now
This updated guidance reinforces that SPPs are not a “simplified pathway” but a complex regulatory construct requiring careful assessment.
Manufacturers should:
Reassess whether their product combinations qualify as SPPs or standalone devices
Review contractual responsibilities between manufacturers and assemblers
Ensure alignment of IFUs, intended purposes, and technical documentation
Verify CH-REP strategy for Switzerland
Evaluate risks of triggering full manufacturer obligations
Read the full document below.
