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New Changes in Switzerland's Medical Device Market: Key Points for Swissdamed Database Registration

Recently, the Swiss Agency for Therapeutic Products (Swissmedic) officially announced that the second module of the medical device database Swissdamed, namely "Device Registration", will release its first version (voluntary registration) in 2025, which is expected to accelerate market supervision and information transparency.

## About the Swissdamed Database

Swissdamed is a new database developed by Swissmedic. Its core function is to serve as a public platform for the registration and management of economic operators and medical devices (including In vitro Diagnostic Medical Devices, IVDs) in the Swiss market, and it functions in a similar vein to the European Union’s Eudamed database. The database will integrate, process, and disclose information about medical devices and relevant enterprises (e.g., manufacturers), enabling the public and healthcare professionals to access such information more conveniently and significantly enhancing market transparency.

## Launch Schedule of Database Modules To ensure a smooth transition, Swissdamed will roll out its modules in phases:

- **August 6, 2024**: The first module "Actors (Economic Operators Registration)" was officially launched, allowing economic operators to complete registration online immediately. (Manufacturers not based in Switzerland are not required to complete the relevant registration and filing procedures on their own; this will be handled by their Swiss Authorized Representative (CH-REP).)

- **From 2025 onwards**: The second module "Devices (Medical Device Registration)" will be launched in multiple phases. After the initial release, "regulated devices" (i.e., devices compliant with the Medical Device Regulation (MDR) and In vitro Diagnostic Regulation (IVDR)) can be registered, and subsequent updates will continuously improve the functionality of this module.

## Key Timelines for Medical Device Registration - **From July 1, 2026**: All devices, systems, and procedure packs placed on the Swiss market must be registered in Swissdamed. - **By December 31, 2026**: Manufacturers or their authorized representatives must complete the registration of all devices by this date.

Special Reminder: From July 1, 2026, if reports of serious incidents, field safety corrective actions, or relevant trends are involved, the corresponding devices must be registered immediately.

## Compliance Actions for Manufacturers to Market Products in Switzerland 1. Must appoint a Swiss Authorized Representative (CH-REP). 2. With the assistance of the Swiss Authorized Representative, manufacturers shall complete the economic operator filing in Switzerland’s Swissdamed database (voluntary from now on and mandatory from 2026). 3. Complete medical device registration, including the Unique Device Identifier (UDI), Basic Unique Device Identifier (Basic UDI-DI), etc.

4. Improve post-market surveillance procedures to ensure prompt reporting of adverse events when they occur.

Original Official Source: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank.html