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UDI in Switzerland

Overview​

The Swiss UDI system mirrors the EU MDR/IVDR UDI requirements. All medical devices (with limited exceptions) placed on the Swiss market must carry a Unique Device Identifier (UDI). The UDI system is implemented through the DAPI database rather than EUDAMED.

UDI Structure​

UDI-DI (Device Identifier) — Fixed component specific to the device model (labelled item). Identifies the specific version or model of the device. The BASIC UDI-DI identifies a device group.

UDI-PI (Production Identifier) — Variable component identifying specific production units. Includes: lot/batch number, serial number (where applicable), manufacturing date, expiry date, software version (for software devices).

Issuing Agencies​

Manufacturers must use an accredited UDI issuing agency to obtain a UDI-DI:

  • GS1 — Uses GTIN (Global Trade Item Number) structure
  • HIBCC — Health Industry Business Communications Council
  • ICCBBA — For blood, tissues, cellular therapy products

DAPI UDI Registration​

The BASIC UDI-DI (and device-specific UDI-DIs) must be registered in DAPI before placing the device on the Swiss market. DAPI registration requires: device description; intended purpose; device class; manufacturer and CH REP details; UDI-DI data.

Carrier and Labelling​

The UDI carrier (barcode or RFID) must appear on the device label. The carrier type (linear barcode, 2D DataMatrix, RFID) depends on device type and class. The human-readable interpretation of the UDI must accompany the barcode.

IVD UDI Requirements​

IVDs under IVDO are subject to equivalent UDI requirements. The UDI-DI for IVDs is registered in DAPI. Performance studies conducted under ClinO-MD may be exempt from UDI labelling requirements.

Official Sources​

Disclaimer

AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.