Swissmedic Launches swissdamed UDI Devices Module Ahead of 2026 Compliance Deadline

Switzerland’s Swissmedic has introduced the swissdamed UDI Devices module for medical device registration. Since August 2024, swissdamed has served as the national database for medical devices, and now it supports registration of medical devices, in vitro diagnostic devices (IVDs), and procedure packs. While use of the module is currently voluntary, it will become mandatory from 1 July 2026 for all devices placed on the Swiss market.

Key Updates in Swissdamed UDI Devices Module

Swissmedic has rolled out the swissdamed UDI Devices module to strengthen regulatory oversight. Companies can now register:

• Medical devices

• In vitro diagnostic medical devices (IVDs)

• Systems and procedure packs

This phased approach allows manufacturers and other operators to adapt before the 2026 compliance deadline.

Who Must Register Under Swissdamed?

Registration applies to specific economic operators, including:

• Swiss manufacturers

• Authorised representatives in Switzerland

• Persons assembling systems and procedure packs

Compliance Timeline and Deadlines

• August 2024: Swissdamed database went live

• February 2025: UDI Devices module opened for voluntary use

• 1 July 2026: Registration becomes mandatory for all devices placed on the market in Switzerland

Impact on Medical Device Market Access in Switzerland

The new swissdamed requirements align Switzerland more closely with international UDI systems, improving traceability, safety, and transparency. Companies that prepare early will benefit from smoother compliance and avoid last-minute bottlenecks before the 2026 deadline.

How to Prepare for Swissdamed Registration

To stay compliant:

1. Familiarize your regulatory team with swissdamed functionality

2. Collect UDI data for all devices and IVDs

3. Ensure authorised representatives understand their responsibilities

4. Begin voluntary registration ahead of the mandatory deadline

Internal Links

• Pure Global - Swissmedic Switzerland Medical Device Registration

External Links

• Swissmedic – Swissdamed Registration Information (official site)

• IMDRF – Unique Device Identification (UDI) guidance

Switzerland’s Swissmedic requires medical devices, IVDs, and procedure packs to be registered in swissdamed. The UDI Devices module, launched in 2025, is voluntary until 1 July 2026, when registration becomes mandatory. Obligations apply to Swiss manufacturers, authorised representatives, and system assemblers. The update improves traceability and aligns Switzerland with global UDI systems.