Swissmedic Guidance Regarding System & Procedure Packs 

Swissmedic has issued a new guidance document outlining the obligations for the assembly and labelling of systems and procedure packs(SPPs), as well as the associated obligations of economic operators in Switzerland and Liechtenstein. It applies to: 

• Assemblers / System & Procedure Pack Producers (SPPPs) 

• Swiss Authorized Representatives (CH-REP) 

• Manufacturers, importers, and distributors 

It covers assembly, labelling, registration, and vigilance reporting — complementing the general obligations for individual medical devices. 

Key Takeaways From Swissmedic’s New System and Procedure Pack Guidance

Key Definitions 

• Procedure Pack – Devices packaged together for a specific medical purpose (e.g., surgical kits, first-aid kits). 

• System – Combination of devices intended to be connected or combined for a specific medical purpose (packaged together or not). 

• Assembler (SPPP) – Person or company assembling or sterilizing SPPs. 

• CH-REP – Swiss-based authorized representative for foreign manufacturers or assemblers. 

Note: A system or procedure pack can include medical devices, IVDs, or other products, but each item must meet its own regulatory requirements and be combined in line with its intended use. 

Examples of Procedure Packs and Sytems not Included

Specific examples of SPPs and product combinations not considered an SPP are included below: 

Examples of Systems	Examples of Procedure Packs	Delimitations – Not Considered SPPs
Modular components of a knee implant	Combination of surgical instruments for a specific operation	IVD kits – Sets of components for specific in vitro diagnostic examinations
Computed tomography system consisting of a device, monitor and software	First aid kits	Combination products – Medicinal product + medical device inseparable units (medicinal part primary)
X-ray system	—	Assembled on request – Products assembled/provided by a supply chain actor for a professional user or hospital, not combined for a specific medical purpose and not placed on the market
—	—	Healthcare institution manufacture/use – Devices made and used within healthcare institutions under Article 5(5) MDR
Examples of Systems	Examples of Procedure Packs	Delimitations – Not Considered SPPs

Swissmedic System Procedure Packs Obligations

1. Assembler’s Statement (Art. 22 MDR) 

Assemblers must confirm: 

• Devices are compatible as per manufacturer instructions. 

• Correct packaging and inclusion of all required product information. 

• Internal monitoring, verification and validation of assembly activities. 

• For sterile packs: sterilization done per manufacturer instructions using an approved conformity procedure. 

2. When SPPs Become Devices in Their Own Right 

If an SPP contains: 

• Non-CE-marked devices 

• Incompatible combinations 

• Non-compliant sterilization (it must be treated as a device in its own right and undergo a full conformity assessment before market placement.) 

3. CH-REP Requirements 

• Every foreign-manufactured device in an SPP must have a CH-REP. 

• If the SPP itself is assembled or sterilized outside Switzerland, it also needs its own CH-REP. 

4. Labelling & Product Information 

• SPPs (not devices in their own right) do not get a CE mark, but must show: 

• The name, registered trade name, or registered trademark and contact address of the assembler/sterilizer. 

• CH-REP details if foreign 

• Must include all MDR Annex I Chapter III labelling elements (e.g., identification, intended purpose, lot/serial number, storage conditions). 

• Instructions for Use must meet MDR requirements and be in all three Swiss official languages (exceptions possible). 

Note: For SPPs produced by foreign assemblers under the old legislation, the details of the CH-REP for the SPP must be provided on the label or in the instructions for use. 

5. Registration & Notification 

• Anyone placing an SPP on the market must register their contact name and address with Swissmedic within 3 months. 

• Swiss-based suppliers of SPPs must notify Swissmedic of their name, address, and a description of the devices no later than the date the devices are first placed on the market. 

6. Vigilance 

• Assemblers (or CH-REP if applicable) must report serious incidents and field safety corrective actions (FSCA) to Swissmedic. 

• Professional users must also report serious incidents. 

FAQs – Quick Points 

• Legacy SPPs (under MDD) can still be marketed if they meet transitional requirements — but can’t be newly notified under old law. 

• Systems don’t need to be packaged together, but compliance information must be available. 

• Procedure packs don’t carry a CE mark but must include assembler/sterilizer identification, UDI, and traceability details. 

How MedEnvoy Can Support 

MedEnvoy helps manufacturers, assemblers, and distributors navigate Swissmedic’s SPP requirements by providing: 

• Swiss Authorized Representative (CH-REP) services for both individual devices and assembled packs. 

• Compliance gap assessments to identify missing documentation, labelling, or conformity steps. 

• Preparation and review of Assembler’s Statements (Art. 22 MDR) and supporting evidence. 

• Registration support with Swissmedic. 

• Ongoing vigilance management, including incident reporting and FSCA coordination. 

• Training for internal teams on SPP assembly, labelling, and regulatory obligations. 

MedEnvoy offers expert regulatory support to manufacturers in navigating Swissmedic requirements. Whether you need full regulatory management or targeted support, MedEnvoy ensures your systems and procedure packs meet Swiss requirements and avoid market delays. We encourage you to reach out to our regulatory experts here.