SWISSMEDIC SWISSDAMED Registration Obligations for Devices 2026

SWISSMEDIC SWISSDAMED registration 2026 clarifies mandatory device registration for IVDs, medical devices, and MD-DEVIT products in Switzerland. Effective 1 July 2026, all registrations must be completed in SWISSDAMED, with a transition period until 31 December 2026. Manufacturers, importers, and authorized representatives should plan device registration carefully, aligning with EU EUDAMED timelines, to ensure compliance and avoid regulatory actions.

Scope of SWISSDAMED Registration

SWISSMEDIC now requires registration for the following categories:

• Medical devices, systems, and procedure packs – per Art. 108 MedDO  

• MD-DEVIT products – per Art. 2a para. 2 Therapeutic Products Act and Art. 108 MedDO  

• In-vitro diagnostic devices (IVDs) – per Art. 90 IvDO  

These requirements align Switzerland with EU EUDAMED registration obligations, which take effect in the EU from 28 May 2026 (transition period until 27 November 2026).

Key Deadlines and Transition Period

• Mandatory registration starts: 1 July 2026  

• Transition period ends: 31 December 2026  

• Economic operators must ensure that devices, systems, and procedure packs are registered within this timeframe to avoid noncompliance penalties.  

Alignment with EU EUDAMED Database

The EU Commission Decision (EU) 2025/2371 confirmed that EUDAMED modules—Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance—are functional. SWISSDAMED will follow a similar structure approximately one month later, requiring:

• Registration of EU economic operators placing devices on the market in Switzerland  

• Registration of all devices, systems, and procedure packs  

• Updating internal QMS procedures to reflect the registration process  

Compliance Considerations for Economic Operators

• Ensure complete and accurate device registrations in SWISSDAMED.  

• Align internal QMS and SOPs with new registration requirements.  

• Be aware that noncompliant data may be easily identified, triggering audits or inspections.  

• Coordinate registration timelines with EU EUDAMED deadlines to avoid gaps.  

Internal links:

• Learn more about Swissmedic Switzerland Medical Device Registration

External links:

• SWISSMEDIC Medical Devices Market Access

• SWISSMEDIC MD-DEVIT Notification

• SWISSMEDIC IVD Registration

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