Unique Device Identification (UDI) in Switzerland – Swissmedic Implementation

Legal Basis and Scope

Unique Device Identification (UDI) became mandatory in Switzerland following the revision of the Medical Devices Ordinance (MedDO) effective 26 May 2021. The requirement aligns Swiss regulation with the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), which introduced UDI globally through the International Medical Device Regulators Forum (IMDRF) framework. UDI applies to all medical devices (except certain low-risk custom-made and investigational devices) placed on the Swiss market, regardless of risk class. UDI – Eindeutige Produktidentifikation - Swissmedic

UDI Components

A complete UDI consists of two parts:

• UDI-DI (Device Identifier): Static code identifying the device model/version, labeler (manufacturer or private labeler), and specific attributes (e.g., packaging level).
• UDI-PI (Production Identifier): Variable code containing production-specific data such as lot/batch number, serial number, expiration date, or manufacturing date.

The UDI must be presented in both human-readable form (HRI) and machine-readable form (AIDC – e.g., barcode, QR code) on the label and packaging.

Assignment and Issuing Agencies

Manufacturers assign UDIs using one of the accredited issuing agencies recognised by Swissmedic:

• GS1
• HIBCC
• ICCBBA (for blood/tissue products)
• IFA GmbH

The agency provides the UDI-DI prefix and structure; the manufacturer generates the full UDI and ensures consistency across markets.

Implementation Timeline and Transition

Swissmedic adopted phased implementation mirroring EU timelines:

• Class III and implantable devices: Full UDI compliance required since May 2021 (with transitional provisions for legacy devices).
• Class IIa and IIb: Subsequent phases.
• Class I: Final phase. Legacy devices (previously certified under old directives) benefit from transitional arrangements until expiry of certificates or specific cut-off dates.

Database Integration and Obligations

• Swiss Database: UDI-DI and core data elements are registered in the Swiss Product Registration Database.
• Economic Operators: Manufacturers, authorised representatives, and importers must ensure UDI is correctly applied and maintained in documentation.
• Post-Market: UDI facilitates rapid identification during vigilance activities, field safety corrective actions, and recalls.

Practical Guidance

Swissmedic publishes detailed FAQs, technical specifications, guidance on compatible barcodes, and examples of correct UDI presentation. Manufacturers are encouraged to integrate UDI early in labelling processes and verify compatibility with Swiss-specific requirements (e.g., language rules). The Swissmedic website provides tools, checklists, and contact points for clarification.

UDI implementation strengthens device traceability across the supply chain, supports faster response to safety issues, and enhances overall regulatory oversight of medical devices in Switzerland. Full details, timelines, issuing agency links, and compliance resources are available on the Swissmedic UDI dedicated page. UDI – Eindeutige Produktidentifikation - Swissmedic