Swissmedic 2025 Guidance on Systems and Procedure Packs

On 8 August 2025, Swissmedic published its updated Information Sheet on Systems and Procedure Packs (SPPs), aligning Switzerland’s requirements with the EU MDR and IVDR. The guidance sets out obligations for assembly, labelling, and vigilance reporting under the Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Medical Devices Ordinance (IvDO)—critical compliance steps for manufacturers and distributors in Switzerland and Liechtenstein.

Key Updates in the Swissmedic SPP Guidance

Swissmedic confirms that any operator placing SPPs on the market under Art. 11 MedDO must, within three months, register their name and contact address with Swissmedic. This registration requirement formalises a clear timeline for compliance and strengthens traceability in the medical device supply chain.

The guidance also:

• Stresses the importance of vigilance reporting for SPP assemblers.

• Clarifies expected levels of documentation detail.

• Highlights differences between the old Directives framework and the current MDR/IVDR-based legal obligations in Switzerland.

Impact on Medical Device Operators

Economic operators—manufacturers, authorised representatives, and distributors—should expect random checks and compliance inspections from Swissmedic.

Key risks for non-compliance include:

• Delays in market access.

• Potential enforcement actions or penalties.

• Reputational impact with healthcare providers and partners.

How to Comply with the 2025 Swissmedic Requirements

1. Registration: Ensure your business registers with Swissmedic within three months of first placing an SPP on the market.

2. Vigilance Reporting
   Implement systems for prompt identification and reporting of incidents or safety issues.

3. Documentation & Labelling
   Review assembly procedures, labelling, and supporting documentation for MDR/IVDR compliance.

Learn More About Switzerland Medical Device Registration, visit:

Pure global – Swissmedic Switzerland Medical Device Registration

External links

• Swissmedic – Systems and Procedure Packs Information Sheet  

Swissmedic’s August 2025 guidance aligns Switzerland’s systems and procedure packs rules with EU MDR/IVDR. SPP assemblers must register with Swissmedic within three months of placing products on the market, meet vigilance reporting requirements, and ensure MDR/IVDR-compliant labelling. The guidance clarifies differences from the old Directives system and signals that random compliance inspections are expected.

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